clinical research community news


Issue 3 | November 2015


the Network

Meet the new

Specialty Cluster


What makes a

good commercial

research partner?

The NHS tells all

'OK to ask' review

Taking the campaign

to the next level

Oral and



Paving the

way for

future trials




The latest news from the

Clinical Research Network and

the organisations we work with


on the cover




Getting in shape for

the future

The Clinical Research

Network's CEO talks

about organisational

change and progress


Maintaining the

UK's leading-edge

Meet the new clinical

academics who will

help the UK to stay

at the forefront of

clinical research


'OK to ask' ups the


Learn how the

campaign gathered

momentum during



What makes a good

commercial research

delivery partner?

Survey reveals NHS

employees views

research delivery

22 26

The changing face New beginnings at

of community the end of life


The UK's pharmacies

are getting 'researchready'

Research culture is on

the rise in palliative

care hospices in the

south east



foundations for oral

and dental research

Learn how the

Network has

overcome challenges

to pave the way for

future research


Local satellite units

lead international



dialysis units address

key question for

the renal research



PROFILE: Patient


Meet Esther Harris,

expert patient


Weighing up the


Could stepping on

the scales at midwife

appointments prevent

pregnant women

from gaining excessve



Students prove

vital to vaccine


CRN: North West

Coast takes research

out of the clinic and

into the colleges


Enriching the

lives of care home

residents with


Now in its fourth

year, the ENRICH

network is



in view

Get in touch:


Emma Bender

0113 343 0330

Deputy Editor:

Daniel Spiers

0113 343 0372

NIHR Clinical Research

Network Central

Communications Team:

0113 343 0330


Visit the Clinical Research

Network website:

Sign up to receive Insight



Follow us on Twitter:


Tweet using


Find us on Facebook:



Join our LinkedIn community:



The Autumn 2015 edition of Insight comes hot on the heels of the publication of our

annual research activity league table. We were delighted to announce that for the third

year running over 600,000 people took part in clinical research studies supported by the

Network. Alongside a year-on-year five per cent increase in the number of studies we

support, the league table reflects the progress we are continuing to make in embedding

clinical research in the NHS (find out more on p.11).

The table also highlights the range of Trusts involved. It’s exciting that environments

historically associated with lower levels of research activity, such as Care and Mental

Health Trusts, are among the top ten to have achieved the largest percentage increase

in the amount of research studies they undertake.

That’s good timing for Insight, since it validates the focus of this issue: introducing

clinical research to new environments. What really shines through is an increased

connection between clinical research and local communities. And we’re not just talking

about GPs.

While GP surgeries continue to play a vital role in research engagement, this issue

shows we are working creatively with a range of other community services and

organisations, including dentists, pharmacists, care homes and universities. Crucially,

this innovative practice is giving more people the opportunity to take part in and benefit

from studies of relevance to them.

Of course, the very nature of clinical research promotes a culture of innovation. It’s one

of the qualities that defines our community, in terms of people and projects. It’s what

makes the Network such a vibrant place to work and it puts us in a strong position to

contribute to the improved health and wealth of the nation, now and in the future.

Jonathan Sheffield, Chief Executive Officer

Autumn 2015 | INSIGHT |



Free online course aims to inform about clinical discovery and evaluation

The Clinical Research Network has

partnered with the University of Leeds

Digital Learning team to create the

‘Massive open online course’ (MOOC)

to provide people around the world

with an opportunity to learn about

clinical research.

The course entitled ‘Improving

Healthcare through Clinical Research’

is a free online course and launched

on 2 November 2015. The course

looks at the detail of research and

how we do it, and is brought to

life through case studies covering

topics such as how research is

helping to find new ways of treating

and providing care for some of the

major diseases including cancer

and dementia. It also focuses on

important ethical questions raised by

clinical research.

The MOOC is being delivered through

the secure FutureLearn Platform and

hopes to reach up to 10,000 learners.

Over four weeks the course will


• Learning about the roles of

different members of a research


• Hearing from people who have

taken part in clinical research


• The ethical and scientific

principles that underpin the

research process

• Getting a better understanding

of the challenges of conducting

clinical research and the benefits

to modern healthcare

A YouTube trailer advertising the free

online course is available to view on

the NIHR TV channel:

The course is available to everyone,

from patients and the public, to

life-sciences industry and healthcare


You can join the course at any time

or find out more by going to:

The MOOC (Massive Open Online Course) is available to all

RCP and Clinical


Network Research

Awards winners


This award scheme recognises the

outstanding contributions of NHS

clinicians to the conduct of Clinical

Research Network Portfolio research

studies in two categories: consultant

and trainee.

Winners receive £1000 and are entitled

to informal mentorship from the

relevant Clinical Research Network

Speciality National Lead.

The Royal College of Physicians

presented the awards at the Harveian

Lecture on 15 October 2015.

• Consultant award winner:

Professor Colin Rees, Consultant

Gastroenterologist at South

Tyneside NHS Trust and Professor

of Gastrointestinal Endoscopy at

Durham University

• Trainee award winner:

Dr Christopher McAloon,

Cardiology Research Fellow and

Ph'D Candidate, West Midlands


N.A.P.P. Research


Award 2015-16


The Research Engagement Award is now in its

second year and celebrates outstanding exemplars of

leadership by Patient Participation Groups in health

research in primary care.

The Clinical Research Network, in partnership with

the National Association of Patient Participation

(N.A.P.P.), launched the award on 10 September.

N.A.P.P. is a patient-led organisation with a particular

interest in patient involvement in primary care,

Patient Participation Groups and research.

The award aims to encourage more Patient

Participation Group members to find out about

health research and provide leadership to help ensure

research is part of the health care choices offered to

patients in general practice.

Applications are sought from general practices,

pharmacies and dentists that show innovative

approaches to research engagement as a result of

work with patients and Patient Participation Groups.

Find out more at:

Global first



The Clinical Research Network

provides support tools to enable

the life-sciences industry to

deliver high-quality clinical

research in the NHS.

Recruiting a first global/European

patient is a key performance

indicator for the life-sciences

industry in clinical research

delivery and demonstrates that

the Network can support the

rapid set-up of studies. To date

(from 2012 when records began)

over 100 first global/European

patients have been recorded by

the Network, with 78 per cent

of that figure representing first

global patients, and 22 per cent

first European patients. Seven

first global patients have been

recruited this finanical year.

To view our latest list of first

global patients visit:


| INSIGHT | Autumn 2015


The Clinical Research Network

has appointed eight clinical

leaders as Specialty Cluster

Leads to help shape clinical

research in the UK.

The role of the Specialty Cluster

Leads is to ensure that the UK

remains at the forefront of clinical

research so that NHS patients can

continue to benefit from leadingedge


Each Lead brings with them

significant clinical research expertise

which will aid development of the

nation’s research infrastructure

and workforce by bringing the

latest intelligence to the Network.

Their knowledge and insight will

also help the Network prepare

to support emerging areas of

technology and innovation, as well

as further improving the quality

and productivity of ongoing clinical


Speaking about the appointments,

Jonathan Sheffield, Chief Executive

Officer, said:

“I’m delighted to welcome our

new clinical leadership team. These

are some of the best brains in

the clinical research community.

Research is all about progress and

CRN and Pfizer



clinical trial

access for UK


A unique collaboration between the

Clinical Research Network and Pfizer

aims to see UK patients among the

first to benefit from a new wave of

innovative medicines development.

This is the first time an entire

national research network has been

invited to participate in Pfizer’s

INSPIRE (Investigator Networks, Site

Partnerships and Infrastructure for

Research Excellence) programme.

the Network must stay agile and be

ready to adapt. These appointments

will both strengthen the Network

and enable us to evolve with the

growing needs of UK healthcare,

so that we can develop better

treatments for patients faster.”

Find out more on page 15.

Professor Dame Sally Davies, Chief

Medical Officer for England, said:

“I am delighted to see the excellent

work of the NIHR Clinical Research

Network being recognised by Pfizer.

The UK has long played a pivotal role

in researching and developing new

medicines, benefiting patients around

the world. This new partnership

between [the Network] and Pfizer is

testament to the important role the

Clinical Research Network plays in

the battle against some of the most

challenging diseases of our time.”

Dr Berkeley Phillips, UK Medical

Director, Pfizer Ltd said:

"Our scientists dedicate their lives to

beating illness and disease, but they

can’t do it alone. We believe that this

exciting new partnership can help

us to find and deliver the treatments

of the future, advancing scientific

research for the benefit of us all.”

The INSPIRE programme will promote the sharing of expert

knowledge and experience of medicines research

Through INSPIRE, Pfizer and the

Clinical Research Network will share

expert knowledge and experience of

medicines research, to help bring more

clinical trials to the UK and to help

deliver the best results for patients in

the NHS. The strategic alliance also

supports the Government’s ambition

to make the UK a world leader in lifesciences.

Further to this strategic alliance, Pfizer

has selected the Greater Manchester

Clinical Research Network to be

part of the INSPIRE programme as a

preferred location for clinical research.

Read the full press release:

Network streamlines and standardises its study support service

The Clinical Research Network is launching its

new Study Support Service, across three phases,

during 2015.

The Network already provides added value to the

research community through a range of guidance

and procedures to support study delivery in the

NHS. The Study Support Service will bring these

separate elements together to improve the

consistency and visibility of Network support.

The service also means that regardless of topic,

location or care setting, investigators and

life-sciences industry companies will receive a

streamlined and standardised service to help

them deliver research throughout the NHS in


The service will consist of these core offerings:

• Early contact and engagement

• Early feedback

• Site identification

• Network delivery assessment

• Effective study set-up

• Performance review

Find out more about the Study Support Service


Watch an animation about the Network's

Study Support Service

Autumn 2015 | INSIGHT |





careers get


Healthcare professionals

are being encouraged to

develop a clinical academic

career through a new

animation developed by

Health Education England

(HEE) and the National

Institute for Health Research.

The animation describes

the opportunities on offer

to all professions as part

of HEE’s Clinical Academic

Careers Framework which

brings together research

programmes funded by HEE

and the National Institute for

Health Research.

The animation is available to

view at:

Further information is

also available on the NIHR




Details of all current

funding opprtunities for

researchers, research

teams and organisations

are available on the

NIHR website:


Generation-R members outside the White House; the official residence of the

President of the United States

Generation-R at iCAN

In June, members of NIHR’s Generation-R Young People’s Advisory

Group (YPAG) were invited to attend the International Children’s

Advisory Network (iCAN) Launch and Research Summit in

Washington DC, USA.

The purpose of the event was to bring together youth members

and their parents from around the world to share their experiences,

learn from one another, and engage with world leaders in medicine,

research, innovation and advocacy.

Katherine Shaw (15) and Sarah Moneypenny (18) attended the

event, alongside YPAG facilitator Kirsty Widdowson.

Katherine and Sarah said: “We learnt a lot of new things about

clinical research in children and how much the input of young people

is beneficial.

“We thoroughly enjoyed meeting new people and making new

friends with people who, like us, are in a Young Person’s Advisory

Group, as we could compare what we do in the groups and learn

from each other. Being given the opportunity to visit Washington DC

and to represent the United Kingdom was a fantastic experience and

one we will always remember.”

For more information read Katherine and Sarah’s blog: cr click on the 'play' icon to watch Katherine

and Sarah’s video diary.

Charity research investment infographics

The Association of Medical Research

Charities (AMRC) has produced

a new infographic looking at the

investment and impact of medical

research charities.

You can see the infographic

here: Medical research charities:

investment, innovation, impact -

Also available on the AMRC

website are some materials looking

in more detail at the areas explored

in the infographic.


of non-commercial research

on the NIHR portfolio in 2015

was funded by charities




in shaping



At the NIHR, patients and the

public are at the heart of what

we do. They help to ensure that

our research is relevant, useful

and accessible to everyone. But

did you know that they also

help us decide what needs to

be researched?

You don’t have to be a doctor,

a clinician or an academic to

submit a research suggestion

to the NIHR. We welcome

suggestions from patients,

carers and members of

the public whose detailed

knowledge of living with

conditions and insight into the

practicalities of treatment is

invaluable to us.

If you have identified

something we can investigate

and test, we want to hear from


Maybe it’s a treatment that

would work better than

current practice. Maybe

current care needs to be

delivered in a different way.

Whatever your idea is, let us

know by completing our short

suggestion form. Please give

as much information as you

can, but if you can’t answer a

section just leave it blank. We

still want to hear your ideas.

To find out more visit:

















& immune


AMRC members fund essential research

in all areas of health and disease


| INSIGHT | Autumn 2015

Dr Susan Hamer, the Network’s

Nursing, Learning and

Organisational Development

Director, has been recognised

in the first ever Nursing Times

Leaders list revealed this autumn.

The list, which also forms a special

supplement in the Nursing Times

publication, celebrates nurses

and midwives who have been

pioneers, entrepreneurs and

inspirational role models to their

profession. Nursing Times’s Editor,

Jenni Middleton, says in her

foreword for the new supplement:

“We were looking for a set

of nurses who have changed

practice for the better, shown

visionary thinking, had a major

positive impact and role modelled

exceptional behaviours for others

to imitate.”

Update from the HRA

HRA – a year in review

In 2014/15 the Health Research Authority

(HRA) continued its work to improve the

environment for health research in the UK

through its improvement programmes.

The organisation has shared progress from

the past year through its Year in Review

publication, which tells the story through

the experiences of patients, the public and


The highlights of the publication are:

• Listening to patients and the public –

read about HRA work with patients

and the public to lead on the new

UK wide policy framework to replace

the Research Governance Framework

and watch workshop videos on

proportionate consent in large

pragmatic trials

• Transparency in research – learn about

HRA work with partners to promote

transparency in research and continue

to build public confidence in it

• Making health research more efficient

– find out how the new pharmacy

and radiation reviews have created

efficiencies for researchers and


A Year in Review an be accessed via the

HRA website:

Earlier this year Dr Hamer was

also recognised in the HSJ

(Health Service Journal) Clinical

Leaders list for her work in

advancing clinical academic

careers for nurses and allied

health professionals. Speaking

about the HSJ recognition Dr

Hamer said:

“I’m really delighted to be

nominated and thrilled that the

importance of clinical leadership

for delivering high quality

research has been recognised.

This is an exciting time to be a

leader in a rapidly developing

and innovative field of practice.

The nurses and clinicians I work

with constantly strive to be the

best and deliver their best, the

least I can do is to try and do the


View the Nursing Times Leaders


HRA Approval roll out is simplifying

approvals for research

Research in primary care in England is now

benefiting from the new simpler approval

process implemented by the HRA.

The new HRA Approval process is being

implemented across the NHS in England

during the course of 2015 in a phased

approach. The new process involves an

assessment by the HRA alongside the

ethical review process, providing a single

authoritative approval for the NHS. This

means that NHS organisations no longer

need to duplicate research governance

checks and can focus on ensuring there is

the appropriate capacity and capability to

deliver studies on time.

Researchers who are planning to seek

approval for a new study over the next few

months should check the HRA website to

see whether their study is eligible to apply

for HRA Approval:

Local Clinical Research Network teams

and R&D Offices will continue to support

local research teams and sponsors with

the effective set-up and delivery of studies

across the NHS.

Sign up to the HRA bimonthly newsletter:

Network director receives double recognition for clinical leadership

Dr Susan Hamer

View the HSJ Clinical Leaders list:

Autumn 2015 | INSIGHT |




the NHS


The NIHR exhibited at this year’s

Health and Care Innovation Expo

on 2-3 September in Manchester.

The Expo is one of the NHS’

biggest events and celebrates

world leaders in science,

research and innovation. The

NIHR exhibition space focused

on increasing awareness of

clinical research as a means of

innovation. Find out more:

The NIHR also led two sessions

at the event’s ‘Pop-up University’

agenda; a series of high quality

workshops open to all delegates

at the event.

Matt Cooper, the Clinical

Research Network's Business

Development and Marketing

Director, presented a session

entitled ‘Growing the health and

New Industry Alliance partnership struck with Pfizer

will boost cancer research

Collaboration CRN and Pfizer working together to help

beat cancer

wealth of the nation’ alongside

other NIHR colleagues. He said:

“In the past the NHS has had

a reputation for being slow at

delivering clinical research studies

but we know that today that’s

simply not true. The Clinical

Research Network has been

working hard at improving

relationships with life-sciences

companies internationally in

Ministerial visit Life-Sciences Minister, George Freeman, with the NIHR team at the NHS Expo

recent years, to encourage them

to bring more of their studies

to the UK. So opportunities like

this provide another chance to

bust those myths and get across

the real facts about delivering

research in the UK and how it

brings value to the UK economy.”

Find out more about the NIHR’s

contribution to the ‘Pop-up

The Clinical Research Network has

announced a new partnership with global

biopharmaceutical company, Pfizer, which

will further maximize cancer research

activity in England.

The Industry Alliance is an academic

partnership between the Network and

Pfizer with an objective of optimising early

phase testing of new anti-cancer therapies.

The primary driver behind the Industry

Alliance initiative is patient benefit – by

supporting the life-sciences industry in this

way more compounds can be tested for

clinical effectiveness across a wider range of

cancers, ultimately leading to more patients

gaining faster access to cutting edge


This is the fifth Alliance of its type to be

signed with the Network and a commercial

company with further Alliances already in

existence with AstraZeneca/MedImmune,

GlaxoSmithKline, and Verastem. These

existing Alliances have resulted in the rapid

growth of industry-supported, academically

sponsored trials.

University’ agenda:

Click on the 'play icon' to

watch a video of Matt Cooper,

CRN's Business Development and

Marketing Director, describing

the role of the Business

Development Directorate in

promoting the Clinical Research


George Freeman, Minister for Life-Sciences,

said: “Partnerships between the NIHR

and leading life-sciences research and

development companies are vital to improve

the health and prosperity of the nation

through pioneering biomedical innovation.

By harnessing the world leading expertise

that exists in our universities and NHS, we

can ensure that cancer patients are able

to access the latest medical innovations as

quickly as possible.”

Dr David Montgomery, Medical Director,

Pfizer Oncology UK commented: “Pfizer

is proud to be partnering with the NIHR

Clinical Research Network as part of our

ongoing commitment to developing medical

advancements to help in our fight to cure

or control cancer. Collaboration between

academia and industry is vital, and this

Alliance will help bring new trials and new

treatment options to patients in the UK.”

Read the full story on the Clinical Research

Network website:


| INSIGHT | Autumn 2015




One NIHR was launched

in June to promote and

celebrate the people

funded, supported and

working for the NIHR. Its

aim is for people to stand

proud and recognise that

no matter who they are,

where they work or what

they do, if they are part

of the NIHR, they are an

invaluable asset.

A ‘One NIHR’ website has

been created to support

the initiative. It is tailored

to the different groups of

people who make up the

NIHR with tools to help

them be ambassadors and

spread the word about

clinical research.

‘I am NIHR’ pin badges

are also available to NIHRfunded

and affiliated

colleagues to promote

their NIHR identity in their

working day and raise the

profile of the organisation

among colleagues,

patients and the public.

If you would like to find

out more about One NIHR

or to request an ‘I am

NIHR’ pin badge contact:

To find out more about

the NIHR and keep

up to date on news,

developments and


Visit the NIHR website:

Follow us on Twitter:


Celebrating UK bioscience

Bioscience is a fundamentally

important sector for the UK’s

health and wealth.

UK bioscience may seem to

hide its successes under a

bushel, due to the nature of the

business. Developing medicines

and technologies takes over

a decade. Multiple parties –

universities and companies,

small and large – are often

involved. You can’t touch, drive,

download or fly the output

of biotech. The science is

complicated and each product

has several confusing names

along the way. The net effect is

that there is a lack of awareness

of how successful UK bioscience

is in delivering astonishing new

innovations and therapies that

benefit patients and the public.

With this in mind, in June

this year, the UK BioIndustry

Association (BIA) published

Celebrating UK bioscience:

unravelling the stories behind

UK bioscience success which

explains how the sector develops

therapies and products that are

changing lives for the better. The

report aims to unravel the stories

Bioscience refers to sciences that deal with the biological aspects of living organisms

UK bioscience funding at 10 year high

Financing for UK bioscience

companies has reached its

highest level for at least a

decade in an echo of the

biotech boom in the USA.

According to a new report from

BIA and life-science market

intelligence firm, Evaluate Ltd,

over the past 10 years, the UK’s

biotech sector has outperformed

other European countries,

raising an impressive £923.7

million via IPOs (Initial Public

Offerings) and $2.4 billion in

venture capital (VC). The rise in

optimism has been most evident

in 2014 with the momentum

continuing into 2015.

2014 was a big turning point

for the UK biotech sector. In

this year alone, on the public

market, nine companies listed,

raising a total of £408 million,

almost half of the total IPO haul

for the past decade.

UK venture capital financing

also improved in 2014, jumping

71 per cent from the previous

year to $430m, with VC firms

doing fewer, bigger rounds

at an earlier stage. On the flip

side, seed funding of early

stage companies by venture

capital has fallen dramatically

and highlights the need for

alternative funding and the

return of specialist investors

behind just some examples of

UK bioscience success, through

six case studies. These are only

a snapshot of the full spectrum

of UK bioscience successes, past

or ongoing, but help illuminate

where UK bioscience is shaping

scientific innovation and is

delivering benefits to humanity.

The report aims to raise

awareness and understanding

of, and pride in, the pivotal

role of UK companies and the

ecosystem they thrive in. To

download the full report, visit

willing to take a more long-term

view of the industry.

The full version of the UK

Biotech: A 10 Year Horizon

report can be downloaded at:

Autumn 2015 | INSIGHT |



New research facility at Alder Hey

In October, Alder Hey Children's Hospital in Liverpool

took a significant step forward as a global leader in

children's health care, innovation and research, when

it opened ‘Alder Hey in the Park’, a new state-of-theart

children’s hospital, and new Research, Innovation

and Education Centre.

Alder Hey in the Park will bring together excellent

care, technology and design to provide the best

possible healing environment for children and

their families. Coupled with first class teaching and

research, it will help them continue to attract the best

talent in the world.

The three storey ‘Institute in the Park’ is home to

around 100 research, education and clinical staff,

including the Clinical Research Network Coordinating

Centre team overseeing the specialty cluster for

Children, Haematology, Musculoskeletal disorders,

Ophthalmology and Reproductive health and


Professor Beresford, Specialty Cluster Lead and

Borough Chair of Child Health in Liverpool, who has

been among the key leaders of this initiative, said:

"The new facility provides a world-class, child

centred centre of expertise that allows researchers

to significantly enhance our care for children and

young people and develop safer, better medicines

for children to use in the NHS and throughout the

world. It will also help give children in the north west

greater access to emerging life-saving technologies

and provide world-class facilities to continue to attract

outstanding researchers to Liverpool."

A video about the new hospital is available on the

BBC News website:

State of the art an artist's impression of the new

research facility




22 Sept 2015

Dr Susan Hamer discusses

the nurse's changing role

in clinical research - -


8 Sept 2015

My role as a patient

research ambassador has

inspired me to become a

service-user researcher -

now applying for #PhDs,

honoured! #PRATalk


14 Aug 2015

'Dementia research

boosted by surge in

volunteers' @BBCNews



2 July 2015

Sally Davies: "I am

delighted to see the

excellent work of the

@NIHRCRN being

recognised by @pfizer"


Winner The overall winning entry was submitted by Steve Wittikar, East Lancashire Hospitals NHS Trust

NIHR photographic competition 2015 winners revealed


21 May 2015

#ICTD2015 best

moment... Surprise

appearance of Ken Dodd

joining the #oktoask

party with foam hands

sans-tickle stick



The winning entries to the NIHR photographic competition 2015 were revealed in September. The

theme was ‘Equality and Diversity’ and celebrates the work of everyone involved in the NIHR including

patients, the public and carers. The competition attracted over 60 entries from across the NIHR. The

10 winning entries were selected by an independent panel including public and NIHR representatives.

Professor Dame Sally Davies, Chief Medical Officer and Chief Scientific Adviser, chose the overall winner.

The 10 winning entries can be viewed on the NIHR website:

10 | INSIGHT | Autumn 2015




In October the Clinical Research Network

published its annual league table,

revealing an increase in clinical research

activity across the NHS in England.

The league table, now in its fifth year,

details the number of clinical research

studies undertaken by each individual

Trust, and the number of participants

they recruit into those studies.

A special mention goes to Newcastle

Upon Tyne Hospitals NHS Foundation

Trust who currently top the table for

the fourth year running for quantity of

research with 486 studies, an increase

of seven studies on last year’s figure.

But the Network also recognises

University College London Hospitals

NHS Foundation Trust for showing the

largest increase in research activity by

conducting an additional 52 studies

compared to the previous year.

The league table categorises NHS

Trusts into organisations with

alike characteristics, which allows

comparisons to be made between Trusts

in similar circumstances. Viewing the

data in this way demonstrates that NHS

organisations of all types and sizes are

increasing the reach of research and

giving more patients the chance to take

part. Care and Mental Health Trusts –

historically both environments of lower

research activity – are among the top

ten Trusts that have achieved the largest

percentage increase in the amount of

research studies they undertake.

Over the last seven years more than

3.8 million people have taken part in

clinical research studies supported by

the Network which is evidence of the

growing profile of research throughout

the NHS. Commenting on the league

table results, Professor Dame Sally

Davies, Chief Medical Officer and Chief

Scientific Adviser, Department of Health,


“Yet again our world class National

Institute for Health Research

infrastructure has shown that it

continues to grow and is providing

exciting research projects to benefit our

health service. High quality research is

vital to bring new treatments to patients

as quickly as possible and the Clinical

Research Network is proving to be a real

success in driving forward this essential


The clinical research league table is available


Vital statistics Last year over 618,000 people took part in clinical research studies in the NHS

12,000 people

now signed up to


national service

for dementia


850,000 people in the UK are living with dementia

Over 12,000 people have signed up to

Join Dementia Research to register their

interest in volunteering for dementia

research studies.

The service promises to accelerate the

pace of dementia research by allowing

people, with and without dementia, to

register their interest in studies, helping

researchers find the right participants at

the right time.

Professor Martin Rossor, the NIHR National

Director for Dementia Research, said:

“The fantastic response we’ve seen to Join

Dementia Research so far is indicative of

the importance of dementia and research

to the wider public. With 850,000 people

in the UK living with dementia, there is a

collective agreement that more needs to

be done, that research plays an important

part in meeting the challenge and that the

public are willing to donate their time to

come together to make it happen.

“We still have a long way to go to spread

the word about the service to people

with dementia and their families living in

towns and cities in every corner of the UK

and make sure everyone knows that the

opportunity is available to them.”

To find out more about the initiative or

register your interest visit:

Autumn 2015 | INSIGHT | 11



the futu

This summer

marked the end of

a period of huge

change for the

Clinical Research

Network. Insight

magazine talks to

CEO Jonathan

Sheffield about


performance and



in good shape for


How has the organisation


The key thing is that we are a much

more streamlined organisation. We

now have a very clear research

delivery model that works across our

entire portfolio of research, across

the whole of England. Plus, we have

a single contract with the

Department of Health whereas

previously there were several. So

we’re a simpler, more straightforward


We also have a new consortium

leading the organisation. What’s

really important about the

consortium is that it’s a combination

of academic excellence through the

University of Leeds, and NHS

excellence through Guy’s and St

Thomas’ NHS Foundation Trust.

Having Guy's and St Thomas’ at the

helm - a flagship Trust in the NHS

- helps us to better understand and

work with the NHS which is

absolutely crucial to the success of

our organisation.

Our core business of delivering

research remains unchanged. But

there are a couple of new aspects to

the Network. One is the addition of

our national Specialty Cluster Leads

who will help us to stay at the cutting

edge of clinical research (find out

more on page 15). We have also

introduced a Business Development

and Marketing team to build new

partnerships, develop new

relationships and ultimately bring

more studies to England.

Why was the structural change


It was necessary for many reasons.

Our previous five year contract came

to an end and the new contract

presented a slightly different brief, so

we needed a refresh and some new

ideas in order to fulfil that brief.

We are also a maturing organisation.

The evolution of the Network has

been ongoing since 2001. We had a

multi-layered structure and

management system which meant

that, while we were very effective at

delivering studies, there was scope

for greater efficiencies and

effectiveness. It was time to look at

our structures to make sure they

were fit-for-purpose, represented

good value for tax-payers money and,

most importantly, fitted with an NHS

which has undergone two major

restructures since the Network


Also, with Simon Stevens, Chief

Executive of the NHS, having laid out

a Five Year Forward View* which

marks a shift in the way that care is

delivered, we have to be responsive

to that change in direction.

What does it mean for the future?

Firstly, we have a structure that is

easier to understand. Our research

and stakeholder consultation has

shown us that the general

understanding of the Network and

the wider NIHR is not as good as we

think it is. So the simplification of the

Clinical Research Network is really

important. If we have a simple

message about how we support and

deliver research we are more likely to

attract studies - that means more

opportunities for patient to

participate in research and better

access to new, cutting edge

treatments and technologies.

Our new structure also works much

better in terms of cross-specialty

working. The NHS Five Year Forward

View describes the complexity of the

modern healthcare environment.

People no longer have single disease

issues, they have multiple and often

chronic diseases. The research that

we support has to be in the context

of the population that we are

treating and therefore the isolation of

specialties is not the way forward.


Autumn 2015 | INSIGHT | 13


What impact have the changes

had on day to day delivery of


We’ve gone from 102 to 15 Local

Clinical Research Networks and from

seven separate coordinating centres,

overseeing eight different networks,

down to one national coordinating

centre. Yet, despite those huge

changes, I’m delighted that we’ve

continued to achieve high levels of

patient recruitment. In 2014/15 we

recruited more than 618,000 patients

which is absolutely remarkable given

the size and scale of the restructure.

Taking the helm Jonathan Sheffield, CEO, has guided the

Network through significant structural change

That said, we always thought that

would be the case because the

disruption was never at the patientfacing

end of the organisation. The

changes were about the

management of the organisation and

making sure that we used the money

in the most efficient way. Our annual

figures show that we have

maintained, and in some areas

improved, our position and that is a

tribute to our staff in the Local

Clinical Research Networks. They

have maintained their focus on

ensuring patients have the

opportunity to take part in research.

Is there more change to come?

As far as the structure of the

organisation is concerned, we can

now look forward to five years of

stability. Inevitably there will be

changes in the research landscape

that we operate in. The investment in

big data is now bearing fruit and the

digital health economy is taking off.

From a big data perspective - it

should become easier for us to find

patients and match them with studies

that are suitable for them. And from

the digital and technological point of

view it should become easier for us to

collect and manage study data and

also to track our delivery and

performance. So yes, there will be

changes in the way that we conduct

and deliver research.

We are moving into a generation of

personalised medicine and already we

are seeing a reduction in the numbers

of patients required to prove efficacy

of a treatment. That’s because

personalised medicine uses genomics

[a discipline of genetics] to identify

and target sub-types of diseases more

effectively with specific treatments.

So, for example, we now know that

there are six different genotypes of

Hepatitis C with multiple sub-types in

each genotype. We also know that

every patient has a different genetic

make-up and one way that our

biological variation makes itself clear,

is in our responsiveness to drugs.

If we can figure out which patients

are more likely to respond to which

treatments we will be able to get to

the evidence for a treatment quicker.

That will mean that the research

journey will be compressed and

ultimately we will move away from

the classic phase 1,2,3,4 model

towards licencing products as early as

phase two.

The first step in that journey will

involve much more screening and

diagnostic testing of patients so that

we can match them to the correct

study – and that can only be done by

a national Network. We will need a

flexible research workforce that is

capable of adapting to change, and

the good news is that we already

have it. Our workforce has already

demonstrated that it can adapt

incredibly well to organisational

change so we know we are in good

shape for any further changes that

are required of us in the future.

"...we can

now look

forward to

five years

of stability”

*The NHS Five Year Forward View:

14 | INSIGHT | Autumn 2015

clinical leadership

Maintaining the UK's

leading edge

Eight senior clinical academics joined the ranks of the Network earlier this year as

Specialty Cluster Leads. Their role? To ensure that the UK remains at the forefront

of clinical research so that NHS patients can continue to benefit from leading-edge

treatments. Insight magazine learns why and how.

Strengthening the Network (Back row left to right) Professors Desmond Johnston, Michael Beresford, Matt Seymour, Stephen Smye, Eric Alton.

(Front row left to right) Professors Paul Wallace, Nick Lemoine (Medical Director), Stuart Parker and Dr Philip Evans.

With a framework of clinical leadership

already in place in the form of National and

Local Specialty Leads, you might be forgiven

for wondering where Specialty Cluster Leads

fit in. Professor Nick Lemoine, the Network’s

Medical Director, sets the scene:

“The clinical research environment is

constantly evolving. The design of studies

is changing and the profile of the people

delivering the research is changing too.

We need to make sure that the Clinical

Research Network can meet the needs of

this changing environment and the key to

this is gathering the right intelligence from

the right people.”

Indeed, each Specialty Cluster Lead brings

with them significant research expertise.

Professor Lemoine continues:

“We are privileged to have been able to

attract such high-calibre academics to

these roles including some of the most

respected and experienced clinical academics

in the country. With their energy, insight

and commitment to excellence we are

well placed to take the Clinical Research

Network to even higher levels of quality and


So exactly how will this new constellation of

clinical leaders help increase the capacity and

capability of the Network to deliver research?

“A key focus of the Specialty Cluster

Leads will be to use their expertise to aid

the development of the nation’s research

infrastructure and workforce and ensure

that the UK is well prepared for supporting

the clinical studies of the future,” explains

Professor Lemoine.

“With that in mind, each new Lead will

spearhead different emerging technologies

in areas of clinical innovation. This includes

sharing the latest intelligence in groundbreaking

areas of medicine such as gene

therapy, metabolic phenotyping and

personalised medicine as well as other

pioneering areas of clinical research utilising

medical technology and informatics. In

addition, one of the Leads has a specific

focus on developing the next generation of

researchers through the National Institute for

Health Research (NIHR) training school.”

A further aspect of the role will be to act

as ambassadors. This will involve working

with the life-sciences industry, research

charities, Royal Colleges, national research

bodies and the Network’s National and Local

Specialty Leads to strengthen links and help

drive the research agenda across all areas of



Autumn 2015 | INSIGHT | 15

clinical leadership

To help contextualise these new roles Insight magazine caught up with two of the

Specialty Cluster Leads. A short biography of each Specialty Cluster Lead is available on

the Clinical Research Network website:

5 minutes with...

Professor Stuart Parker

How would you summarise

the role of Specialty Cluster


In my mind there are multiple

dimensions to fulfilling this

exciting role.

I think the main function is

to be what I call a ‘boundary

spanner’. It’s about bridging

the gap between the

Network and studies on

the Portfolio in my specialty

areas (Ageing, Dementias

and neurodegeneration,

Neurological disorders and

Genetics) with the wider NIHR

and other stakeholders. This

includes looking at alternative

ways of working with external

stakeholders such as research

charities and Royal Colleges.

Another dimension is to support

the clinical leadership through

national specialty meetings

across the Cluster. This is

very much about facilitating

interaction and aiding the

development of the research


A third aspect is having some

responsibility for driving

emerging areas of technology

and innovation for the Cluster

as well as further improving the

productivity of ongoing clinical

research. My special focus is on

the development of the next

generation of researchers by

developing the NIHR Training

School. This will enhance

the development, training

opportunities and research

careers for staff across the

Network and the wider NIHR.

What expertise do you bring

to the role?

Working at Barnsley Hospital

NHS Trust as Director for

Research and Development I

have seen and experienced firsthand

the challenges and barriers

that exist at the grass roots level

when delivering research.

My clinical practice focused

on providing comprehensive

assessment and management

for frail older people in acute

hospital care. That gave me

sound knowledge around

creating opportunities for

bringing the benefits of research

participation to “hard to reach”

or vulnerable participants, which

I shall certainly bring into the


I also spent five years as

Associate Director of the NIHR

South Yorkshire Collaboration

for Leadership in Applied Health

Research and Care which

gave me insight towards the

implementation end of the

research pathway. This was very

much a boundary spanning

role with multiple organisations

involved and different concepts

of research.

I’ve also held leadership roles in

both the acute and community

health care sectors, with service

providers and commissioners,

including chairing a joint agency

group which commissioned

integrated services for older

people for a health and social

care catchment.

How will it add value to the

work of the CRN?

With all this experience,

spanning across the research

pathway, I really hope to add

value to the Network by making

sure that all clinical specialties

within my area have a joined up

approach to research delivery so

that NHS patients can continue

to benefit from cutting-edge

clinical research.

The Specialty National Leads are

crucial in this approach. Each

Lead has existing relationships

with external stakeholders and

part of my role will be to help

them nurture and develop

those relationships, to act as an

ambassador for the Network and

strengthen those relationships

in addition to forging new ones.

For example, we already have

a strong collaboration with the

Royal College of Physicians and

the British Geriatrics Society and

I will be proactively working

with these stakeholders to find

new and exciting ways of linking

up the right people at the right


What do you anticipate to be

the next ‘big thing’?

The next big thing in my area

of research is all about adding

value to the research process and

infrastructure by harnessing large

and existing datasets to bring

data together from multiple and

routinely collected sources –

often referred to as ‘Big Data’.

Big Data has been identified by

the Government as one of 'eight

great technologies' that will

power scientific development

and economic growth over the

next decade and it is applicable

across the innovation and

research spectrum.

With an ageing population

it’s imperative that we look at

developments in using routinely

pooled data sets so that we can

use this information to develop

new methods of research to

enable benefits for patients

quickly and more effectively.

This kind of research is not only

relevant to the clinical specialties

within my area but also the

entire population.

Specialty Cluster Leads are

responsible for the following


Professor Stuart Parker

• Specialty Cluster Lead

for Ageing; Dementias

and neurodegeneration

(DeNDRoN); Genetics;

Neurological disorders

• Emerging technology/

innovation: Development

of the next generation of

researchers through the

NIHR Training School

Professor Michael Beresford

• Specialty Cluster Lead for

Children; Haematology;

Musculoskeletal disorders;


Reproductive health and


• Emerging technology/

innovation: Therapeutics

and personalised/stratified

medicine including clinical


Professor Desmond Johnston

• Specialty Cluster Lead for:

Cardiovascular disease;

Diabetes; Metabolic and

endocrine disorders; Renal

disorders; Stroke

• Emerging technology/

innovation: Medical

technology; Metabolic


16 | INSIGHT | Autumn 2015

Professor Eric Alton

Professor Eric Alton

• Specialty Cluster Lead

for Respiratory disorders;

Ear, nose and throat;


Hepatology; Infectious

diseases and microbiology

• Emerging technology/

innovation: Gene therapy

Professor Matt Seymour

• Specialty Cluster Lead for

Cancer; Oral and dental

health; Surgery

• Emerging technology/

innovation: Medical

informatics and data linkage

Professor Stephen Smye, Dr

Philip Evans and Professor

Paul Wallace (co-Leads)

• Specialty Cluster Lead

for Anaesthesia, perioperative

medicine and

pain management; Critical

care; Dermatology; Health

services and delivery

research; Injuries and

emergencies; Mental health;

Primary care; Public health

• Emerging technology/

innovation: Imaging,

genomics and translational


What attracted you to the

Network role of Specialty

Cluster Lead?

I am privileged to be

involved with the NIHR in

other roles. I’m currently

the Director of the NIHR

Biomedical Research Unit

(BRU) in Respiratory

Disease at The Royal

Brompton and Harefield

NHS Foundation

Trust and Imperial

College London, and

the National Lead

for Respiratory

Diseases for the

NIHR Rare Diseases


Research Collaboration

(TRC). This role with the

Network allows me to join these

to research delivery, rounding

up the research journey, from

scientific discoveries into

clinical trials and eventually into


My role at the BRU is where

the journey begins; it’s the

engine room where we begin

to ‘translate’ basic research

findings and innovations into

medical applications and

products that can go to trial.

The work within the TRC

with rare diseases involves, as

you might expect, working

with small, well characterised

patient cohorts with very

targeted treatments. But it’s

also crucial that we take that

knowledge to help advance

our understanding of more

common diseases so that more

patients can benefit. This is

where the Network comes

in - it is one of the publicfacing

parts of the NIHR which

delivers research opportunities

to the wider population. So

it’s about working along the

whole research path and taking

innovations in treatment right

the way through to patients.

I also believe there is real

scope in this role to bring

about strategic changes and

initiatives that could make a real

difference to clinical research in

the UK – that’s something I’m

really excited about.

Sounds fascinating - can

you give us an example of a

strategic initiative that you

have in mind and how you

plan to go about it?

Ensuring that studies deliver

efficiently to time and target

will always be the Network’s

priority, but I’m also interested

in developing a number of

strategic initiatives across the

whole cluster of specialties that

I, and my team, are responsible

for. So one of the questions

I’m hoping to investigate is

whether or not we should have

an even greater emphasis on

Clinical Research Facilities in

the community as well as in

hospitals. Not all patients are

in contact with hospitals all

of the time and building on

the work already underway to

further develop communitybased

Clinical Research Facilities

could increase our recruitment


I’d like to assess the appetite

for this and working with

the Specialty National Leads

within my Cluster will be a key

component. We’ve already

begun visiting them individually

and I hope there will be interest

and a willingness to be involved.

The discussions will also involve

the wider research community,

research charities, professional

bodies, the life-sciences

industry, patient organisations

and many others.

Each specialty cluster focuses

on an emerging technology

or area of innovation. What

specific area of expertise do

you bring to the Network?

My specialist area is gene

therapy as coordinator of the

UK Cystic Fibrosis Gene Therapy

Consortium which brings

together three major groups

(Imperial College and Oxford

and Edinburgh Universities) in

a translational programme to

deliver gene therapy into the

clinic for cystic fibrosis patients.

So part of the Specialty Cluster

Lead role is about adding value

to the work of the Network

by helping to drive forward

emerging technologies in areas

of clinical innovation. I’ve been

working in gene therapy for

20 years now and we recently

showed that we can produce

small, but significant, beneficial

impacts of gene therapy on

the lung function of cystic

fibrosis patients. The challenge

now is to make those positive

changes bigger and more

consistent. I’m working closely

with pharmaceutical companies

to work out how we take that

next step.

In terms of the Network I’m

keen firstly to look at other

disease areas where gene

therapy can make an impact.

With the current emphasis on

rare diseases and the Genomics

England 100K initiative there

are obvious opportunities.

Secondly, focusing on better

ways that the UK community

can share its considerable

knowledge and expertise.

Gene therapy in cystic


Cystic fibrosis is a genetic

condition caused by a faulty

gene. The gene mutation

causes the lungs and

digestive system to become

clogged up with sticky

mucus. The goal of gene

therapy for cystic fibrosis

is to deliver healthy copies

of the mutated gene to

target lung tissues. In this

latest study the researchers

delivered the healthy

gene into the lungs using

40-minute inhalations, once

a month for year with a

nebulising spray (type of

inhaler) containing fatty

droplets or “liposomes”

wrapped around a healthy,

synthetic copy of the cystic

fibrosis gene.

Autumn 2015 | INSIGHT | 17



clinical research


“...campaigns like ‘OK to

ask’ are absolutely vital

to give people a voice

and empower them to

understand more

about research”

'OK to ask'


ups the


The NIHR's ‘OK to ask’ campaign

entered its third year in 2015 and

has continued to gather momentum.

The campaign, which is led by Simon

Denegri, NIHR National Director for

Patients and the Public in Research,

provides Trusts and healthcare

professionals with an opportunity

to highlight and celebrate clinical

research that’s happening locally. More

importantly, it offers a chance to really

encourage patients and the public to

‘ask’ about research opportunities that

could be available to them.

In previous years, the campaign

has focused its efforts around

International Clinical Trials Day

in May. However this year, the

campaign got underway much

earlier on Twitter with ‘OK to ask

hours’ (tweet chats) running each

week in the month leading up to

International Clinical Trials Day.

Expert panellists from a range

of specialties joined an online

conversation with healthcare

professionals and members of the

public and answered questions

about research.

Simon Denegri describes the impact

of this new campaign feature:

“The specialty-focused ‘OK to

ask hours’ were a fantastic way

for people to get advice and

information from experts about

their conditions. The chats really

opened up the conversation about

making clinical research easier

to access and providing more

information about where patients

and the public can get involved –

not just as a participant in a trial or

study but in shaping research.”

Richard Elliott, Research

Communications Manager at

Diabetes UK, was a panel member

on the diabetes ‘OK to ask’ hour.

He was enthusiastic about being

directly involved in the campaign

and was a great ambassador for

diabetes research by signposting

participants in the hour to recruiting

studies. Along with other healthcare

professionals on the chat, he also

tackled the tricky subject of making

research available to everyone:

“While many people with

diabetes are offered the chance to

participate in research, we know

it’s not as widespread as we’d like

and we would really like to see

that improved. Opportunities like

the ‘OK to ask hour’ provide a

channel for

us to get our

voice heard

and try to

encourage the

NHS to really

get research

to be part of

their everyday y


Wendy Mitchell was

a panellist for the

dementia ‘OK to ask

hour’ in her capacity as

a patient representative. resentative.

This was Wendy’s first

Tweet chat of many relating to

clinical research. She had not

heard of ‘OK to ask’ previously and

explains why she feels public-facing

campaigns around clinical research

are important:

“I was diagnosed with early onset

dementia just over a year ago

and clinical research was never

mentioned as an option that could

be available to me by my clinicians,

so campaigns like ‘OK to ask’ are

absolutely vital to give people

a voice and empower them to

understand more about research.

My journey through the research

landscape has been fascinating and

I’m passionate about telling people

about the advantages of taking part

in research – more opportunities

like the dementia Tweet chat will

make research more accessible to

all and that can only be a good

thing for patients and the NHS.”

A refreshed set of free promotional

materials were made available

to support activities around

International Clinical Trials Day.

NHS Trusts and GP practices used

these resources to promote clinical

research at more than 100 events

18 | INSIGHT | Autumn 2015

Research on the road Northern Devon Healthcare NHS Trust was one of many NHS providers contributing to the 2015 campaign

Campaign leader Simon Denegri spearheads the 'Ok to ask' campaign

and activities across the country. These were

held in a range of places from Trust foyers

and research-active specialty departments, to

shopping centres and even the seaside.

Simon Denegri believes that healthcare

professionals are getting more confident

about the ‘OK to ask’ message and about

taking it out to the general public:

“This year the campaign had a real

grassroots feel to it which was fantastic.

Trusts and GP practices have really taken

ownership of it now and are taking the

message to where people conduct their daily

lives which was part of the original vision for

the campaign in 2013.”

Northern Devon Healthcare NHS Trust have

undertaken a range of activities over the

last couple of years including display stands

and a chocolate trial - designed to give an

understanding of what a clinical study is all

about. This year they decided to up the ante

and took research further afield by jumping

on board the hospital park and ride bus

which picks up patients, members of the

public and hospital staff.

Linda Henderson, Research and Development

Manager at Northern Devon Healthcare NHS

Trust said:

“For this year’s ‘OK to ask’ campaign we

really wanted to take clinical research out of

the hospital and bring it to local people. So

we badged up the bus stops and were out

telling people about clinical research and

why it’s important. Lots of people think that

because the Trust consists of a mix of district

and community hospitals that research

doesn’t happen here; and we really wanted

to remind people that we are a researchactive

Trust, with a growing portfolio of


Following the success of the day’s activities,

Northern Devon Healthcare NHS Trust’s

Chairman, Roger French, has agreed to

be their Research Ambassador meaning

research will now be championed at the

highest level at the Trust.

So as ‘OK to ask’ heads into its fourth year in

2016, which coincides with the NIHR 10 year

anniversary, Simon Denegri tells us his vision

for next year’s campaign:

“I would like ‘OK to ask’ to be an integral

part of the ‘NIHR at 10’ celebrations. It

would be great to see broader support and

more visibility for the campaign from other

national organisations such NHS England.

“This year we saw interest in the campaign

from one or two of the life-science

companies through the ‘OK to ask hours’. It

would be great to get more on board next

year and linking with organisations like the

Association of the British Pharmaceutical

Industry (ABPI) will be key. Research

charities are big influencers over patient

communities, so I would really like to get

more involvement from this sector to really

drive the message to a wider population.

“Ideally, I’d like to get the campaign design

agreed for next year by Christmas so that

people can really plan their own activities

much earlier. I’m sure that by collaboratively

working, we can ensure that 2016 will be

the campaign’s best ever year.”

The NIHR’s evaluation of this year’s campaign

is ongoing and includes a survey of patients,

researchers and others who got involved.

Feedback will be used to inform and improve

next year’s campaign. Look out for the report

which will be published later this year.

"This year the


had a real

grassroots feel

to it..."

Autumn 2015 | INSIGHT | 19

20 | INSIGHT | Autumn 2015

talking point

Online training via our BrightTALK channel


Network Experts training to develop

in-house experts within your company

Get up to date news from the Network by

signing up to our Fast Facts e-newsletter:

Access to standard model agreements

Use our Costing Templates to support

cost negotiations within the NHS

Dedicated support from feasibility, to

set-up and performance management

Query resolution pathway for study wide

and site specific issues

Dedicated assistance via our Study Support Service helpdesk:

Web: Tel: 0113 343 4555


Autumn 2015 | INSIGHT | 21


The following pages

focus on research

delivery across the

Clinical Research



The changing

face of



Traditionally, community pharmacies had a straight forward role:

they supplied medication. But over the last twenty years, as UK

healthcare has focused on moving patients out of hospitals and

into the community, this has changed. Pharmacies offer customers

more support, including clinical services and this is leading to

more potential research opportunities. Consequently, Local Clinical

Research Networks across England are reaching out to community

pharmacies to increase engagement with clinical research. Insight

magazine hit the road to find out more.

Jane Portlock is Professor

of Pharmacy Practice at the

University of Portsmouth and

is working with the Clinical

Research Network in Wessex

(CRN: Wessex) to engage

community pharmacies. She

explains some of the challenges:

“Pharmacists don’t know

what research opportunities

are available, how they could

potentially become involved and

what the possibilities are.

“There is a lack of realisation

within community pharmacy

that they have the expertise

and resource to collect data

for research studies. There is

also a lack of communication

regarding research between

research active GPs and

pharmaceutical companies with


The Network has been

working hard to address the

issues outlined by Professor

Portlock. It has helped the

Royal Pharmaceutical Society

develop the “Research Ready

for Community Pharmacies”

self-accreditation tool, which

is designed to build awareness

of pharmacies’ research

responsibilities to themselves

and to their patients. It also

provides guidance on how to

meet the needs of research


At the same time the Network

is bringing healthcare

professionals together from

across the UK. Anthea Mould,

the Network’s Head of Allied

Health Professionals and

Pharmacy, explains how the

organisation is making this


“We’re creating a community

of practice through our

Research and Pharmacy People

Network and seeking to embed

research practice at a local

level by recruiting Clinical

Research Community Pharmacy

Champions. These champions

work with the wider Network

across England, link nationally

to meet the needs of the

community pharmacy workforce

more effectively and are also

developing a clearer picture of

the infrastructure we need to

support research in this setting.”

These steps are beginning to

bear fruit. There are now 179

Research Ready Pharmacies

in the UK, with 128 being

recruited in 2014 alone.

The impact of this process can

be seen in CRN: West Midlands,

where two pilot schemes

have led the way in engaging

22 | INSIGHT | Autumn 2015

Championing research The Darlaston Jhoots Pharmacy team (left to right):

Kaldeep Singh, Development Services Manager; Robin Jassal, Dispenser and Habil Adamjee, (Locum) Pharmacist

pharmacies. Julie Shenton, the

lead pharmacist, explains the

Local Clinical Research Network’s

introductory process:

“We start off small and simple.

Initially, we ask pharmacies to

promote NIHR campaigns such

as ‘OK to ask’, to help us raise

awareness of clinical research

opportunities. We then ask them

to signpost patients to particular

research studies and finally to

become involved in the delivery

of clinical research.

“Before the pilot schemes there

were no community pharmacies

in the West Midlands engaged

with the Network. We’ve now

got 57.”

Kaldeep Singh is the

Development Services Manager

at Jhoots pharmacy; a small

multiple involved in one of

the CRN: West Midlands’ pilot

schemes. He’s also become the

Network’s Pharmacy Research

Champion for the area. Kaldeep

explains why Jhoots decided to

sign up:

“Jhoots is always looking at

new and innovative roles that

community pharmacists can get

involved in. Being involved in

clinical research has enabled our

pharmacies to offer our patients

new and exciting services.

“It hadn’t occurred to us before

that we could get involved in

"There is a lack of

realisation within

community pharmacy that

they have the expertise

and resource to collect

data for research studies."

research – now we are

wondering why we didn’t do it


Anthea Mould explains how the

Network was able to help:

“The study had to be delivered

during the cough season so there

were tight timelines. However,

because of the engagement

work carried out by the CRN

West Midlands team, the study

was prioritised and they pulled

out all the stops to get sites

signed up and recruitment


Kaldeep continues:

“We are brand new to clinical

research and we are very grateful

for the help we received from

the Network in understanding

how things work. It has played

an essential role in co-ordinating

everyone’s requirements. They

were always available with

support and advice, and to act as

intermediaries where needed.”

Whilst the Network team have

been breaking new ground in

the West Midlands, a similar

drive has been taking place in

CRN: South West Peninsula.

Alphington Pharmacy was the

first in Devon to successfully

complete a national, multi-site

health research study. It was led

by Chief Investigator, Dr Rod

Tucker, and explored diagnosis

and treatment of common skin

conditions by a local chemist

instead of a GP.

Pharmacy Manager Gareth

Smith said: “We signed up

to become research active

because I feel this is an area

where pharmacists already

have strong clinical skills and

experience of advising patients.

Our very first research study

explored community pharmacy

diagnosis and management

of acne and dermatitis. These

are common health conditions

which can easily be managed

by a community pharmacy

without the need for any extra

equipment or lots of additional



Autumn 2015 | INSIGHT | 23


"Patients taking part in health

research studies are able to

tap into the experience from

the pharmacist to complement

the existing primary health

care services. In the acne and

dermatitis study patients were

able to benefit from immediate

advice without having to wait for

a GP appointment."

Gareth’s team successfully met

their recruitment target of four

patients to the study – two with

previously undiagnosed acne

and two with undiagnosed

dermatitis. Using the

consultation room on the shop

premises, they photographed the

skin condition of each patient.

The consultation included

diagnosis, an explanation of their

condition and the recommended

treatment was audio recorded.

Gareth continues: “The

challenging aspect was

perception because there

isn’t the public expectation of

pharmacies to diagnose and

recommend a treatment but

after careful explanation of the

study we were conducting,

the patients we identified as

being suitable were happy to

take part. We raised awareness

within our shop about this

study through posters, shelf

markers in the skin care section

and on our digital information


Alphington Pharmacy has

already started its second

study with the Robert Gordon

University. They’re exploring

whether it is feasible for

community pharmacists

to deliver an educational

programme designed to help

patients self-manage the

skin condition psoriasis, as

effectively as possible.

Nicola, who was recruited to the

psoriasis study by the Alphington

Pharmacy, said:

“Having been diagnosed with

this condition about 15 years

ago I thought I understood

psoriasis and how to treat it but

I was mistaken. It really was a

revelation what I learnt from my

consultation with the pharmacist.

"The challenging

aspect was

perception because

there isn’t the

public expectation

of pharmacies

to diagnose and

recommend a


24 | INSIGHT | Autumn 2015

"I thought I

understood psoriasis

and how to treat it

but I was mistaken.

It really was a

revelation what I

learnt from my...


For example it was better not

to continue moisturising my

skin, which I thought was good

for my skin, when that wasn’t

the case. Also the prescribed

ointment I had been using nonstop

was not advisable. What I

should be doing is using it for

eight weeks then having a break

and only resuming the treatment

when the psoriasis flared up

again. Since following the

new treatment routine my skin

condition has improved.

“When you have a long-standing

health condition you don’t like to

bother your GP with repeat visits

and you tend to resign yourself

to living with the symptoms.

Visiting a pharmacy for a

consultation is more convenient

and it makes sense to keep up to

date with advances in treatments

and refresh your own knowledge

for self-management.”

The work being done to engage

community pharmacy is not

restricted to Wessex, the West

Midlands and South West

Peninsula, it is UK-wide. The

research community is keen

to make progress because it is

clear that community pharmacy

can have a significant impact

on public awareness and

engagement in research.

Prn’s Lindsay Caygill says:

“Pharmacists are ideally placed

to support over-the-counter

medicine research, but they need

more experience to improve

study delivery. Rococo was a

lot of hard work, but it was

really exciting to be part of

something ground-breaking and

I could see the value in what we

were doing. We need to think

about the long-term vision for

clinical research and community

pharmacies have a role to play.”

Professor Portlock agrees that

there is work to be done and

sees the Network as key to

making progress:

“This is really only just starting

– networks are being built

and relationships are being

established. There is huge

potential for pharmacies to

contribute and play an important

part in research. We’re at the

beginning of the story – we need

Network funding and support to

make it work.”

Research success Gareth Smith (left), manager

of the first Devon pharmacy to be research

active, with South West Community Pharmacy

Research Champion, David Bearman, (right)

Autumn 2015 | INSIGHT | 25

esearch in hospices

New beginnings

at the end-of-life

Hospices remain the bedrock of palliative care and although

clinical research is not the main focus of hospice care, more

and more of them are recognising the benefits for their

patients who take part in research studies. Insight magazine

investigates how research culture is changing in Kent, Surrey

and Sussex.

Each year, hospices in the UK support

around 360,000 people with terminal and

life-limiting conditions. As people are living

longer, the number of people receiving

hospice care will only rise. Therefore,

research is vital for hospices to determine

the best and most cost-effective models of

care to ensure that residents continue to

receive quality care at the end-of life.

Hospices do not have the same level of

research infrastructure and resources as

other organisations in the NHS, which has

proved an obstacle to fulfilling research

potential in this environment. This has

not stopped hospices in Kent, Surrey and

Sussex taking part in research studies, but

up until now they have worked in silos as

Dr Siva Subramaniam, from Ellenor Hospice


“We have all been conducting small

research studies in each unit, often carrying

out similar activities, at times unaware of

what each other were doing, so resources

were being wasted.”

Ellenor is one of four hospices in West Kent

who have collaborated on a successful bid

for a Research Practitioner to work across

the four sites to coordinate and support

research activity. Ellenor Hospice, Hospice

in the Weald, Heart of Kent Hospice and

Wisdom Hospice believe that in order to

provide the best possible palliative care, they

need to be part of developing best practice.

Furthermore, staff are keen to take part in

regionally led studies but dedicated support

is required to do so. Tricia Wilcocks, Head of

Development and Quality at Ellenor Hospice


“There is a need to identify Portfolio studies

at an earlier stage of their development, in

order that local hospices are able to take


The Clinical Research Network (CRN): Kent,

Surrey and Sussex supported the hospices

during the development of the bid and will

continue to work with, and support them.

The Network team will act as a mentor to

hospice staff, giving them the confidence

to conduct research activity. Tricia Wilcocks

explains why Network coordination is


“To work with a cohort of people whose

life expectancy is so short, means that you

need to have more of them to participate in

a study; therefore you have to collaborate

with other hospices.”

Another hurdle to conducting research

in a hospice is the underlying feeling

that carrying out research in this type

of environment is unethical, Dr Siva

Subramaniam explains:

“There is a need to change attitudes and

minds as we know that some patients are

keen to take part, but it is the clinical staff’s

attitude that is sometimes a barrier, as they

are protective of their patients. This idea sits

alongside a lack of resource as not having

effective research capacity means that staff

are not exposed to research and what it


Dr Subramaniam hopes that in five years’

time West Kent hospices will have a trackrecord

in delivering successful research

activity that will lead to more funding


Attitudes can be changed as Pilgrims

Hospice in Canterbury has discovered. Rose

Ward has been a Research Nurse at Pilgrims

since they started their first study five years

ago and is funded by the Clinical Research

Network, she said:

“It has been exciting to see how far we have

come, almost to the point that people are

approaching us to take part in studies as we

build on our expertise and reputation. We

are now working towards the opening of

our first controlled drug trial.

“As there is an ageing population, research

is important to give patients the best

possible care and ultimately this will affect

us all.”

26 | INSIGHT | Autmn 2015

What is palliative care?

Charlotte Brigden is a Research Facilitator at Pilgrims

and has seen a shift in research culture, she said:

“As we take part in more research our staff [team] is

becoming research aware and are more agreeable to

be involved. It has become easier to approach eligible

patients to participate in relevant studies.”

Looking to the future, Heather Gillham, Chief

Operating Officer at CRN: Kent, Surrey and Sussex


“It will be exciting to see the difference the new

Research Practitioner will make to the existing

research culture of the four hospices in West Kent

and also to see how research continues to flourish at


Palliative care is the active holistic care of patients

with advanced progressive illness.

Management of pain and other symptoms and

provision of psychological, social and spiritual

support is paramount. The goal of palliative care is

achievement of the best quality of life for patients

and their families.

Many aspects of palliative care are also applicable

earlier in the course of the illness in conjunction with

other treatments.

Improving care Research is vital for hospices to determine the best and most cost-effective models of care

(Image kindly provided by Ellenor Hospice)

Autumn 2015 | INSIGHT | 27

oral and dental health

Building foundations for

oral and dental research


research in


dental practices

has presented

a number of

unique challenges

in the past.

Insight magazine

learns how the

Network's Oral

and Dental

Specialty has been

paving the way

for future research

in this area.

Oral and dental research has

historically taken place in dental

schools (secondary care) yet 95

per cent of patients experiencing

oral and dental conditions are

treated in a primary care setting

by dentists, dental hygienists and

other oral health practitioners. It

makes sense then that research

addressing oral and dental health

questions should seek to recruit

patients in community dental

practices. But this isn't quite as

straightforward as it might seem.

Jimmy Steele, the Network’s Oral

and dental Specialty National

Lead, explains:

28 | INSIGHT | Autumn 2015

Overcoming fears Amy and her

Mum arriving for their appointment at

The Devonshire Quarter Dental Practice

“The business model in dentistry

is different from other aspects

of healthcare. Dental practices

operate as small businesses that

own the estate in which they

work and have traditionally been

paid on the basis of procedures

performed. The payment of the

money goes through different

routes too, resulting in those

responsible for commissioning

dentistry having no mechanism

for covering research costs.

NHS dentistry also carries a

patient charge in many cases,

unlike almost all of the rest of

the NHS, so deciding how that

should be covered was another

complication. We have had to

find new ways of addressing the

funding issues and remunerating

dental practitioners.

“Another major problem was

that each study was slightly

different and raised new

challenges. Variations between

health systems in devolved

nations also caused additional

headaches. We began by sharing

intelligence and setting out

some principles and using them

to underpin all of the business

arrangements. And now, by

using accumulated experience

and shared templates for costing

research support costs, we have

a foundation to work on.

"A further challenge was a lack

of links between primary and

secondary care practices. For the

last decade or more there have

been many efforts to engage

dental practices in research.

For small practices, finding

time to deliver the research is

a real challenge. A number of

academic centres have started

to make inroads with schemes

to train primary care dentists

in research. But it was the

arrival of the Clinical Research

Network that has made the

biggest difference. By supporting

some high quality studies it has

enabled the transformation

of embryonic groups of

research-interested dentists into

established networks of research

professionals delivering properly

funded and reimbursed research


This work is beginning to bear

fruit. Clinical Research Network

figures show a steady increase

in the number of oral and dental

studies over the last five years.

In 2010/11 just 12 studies were

recruiting compared to almost

three times that amount (35)

last year. This is great news

for the oral dental community,

many of whom are keen to get

involved in research that can

provide evidence-based answers

to questions about their everyday


Professor Janet Clarkson is

Co-Chief Investigator of three

Network supported-studies:


FiCTIoN, Interval and IQUAD - all

recruiting in dental practices

across the UK. Janet has firsthand

experience of working with

Network staff to overcome some

of the challenges described by

Professor Steele:

Say Ahhh Dentist and

practice owner Kathryn Houlding

carries out Amy's check up

Autumn 2015 | INSIGHT | 29

oral and dental health

“These studies were conceived

and planned in Scotland where

the rules around service support

costs and remuneration in

dentistry are different… there

was huge support from the

Network to implement changes

for the studies to go ahead in

England. Then, promotion of

the studies included information

events and evenings. Network

staff in Scotland and England

provided extra support and

literature to dental practice

staff… that generous offer of

practical, hands-on Networksupport

was always there.”

The FiCTIoN study compares

three commonly used

approaches to managing decay

in baby teeth. Over 1100

patients have been recruited

across 66 practices in Scotland,

Newcastle, Leeds, Manchester,

Sheffield, London and Cardiff.

Kathryn Houlding, dentist and

owner of The Devonshire Quarter

Dental Practice in Sheffield, sees

over 120 patients per week.

Her dedication combined with

support from the study team

and the Network resulted in

recruiting the first patient in

Yorkshire. Kathryn is an advocate

for research and shares her views

on bringing this kind of research

into the comunity:

“It’s important that you do

research in places where there

is real everyday work – it’s

important that you see what

happens. The majority of patients

access surgeries not hospitals. It’s

not [easy] for a small surgery, but

we are proof it’s not impossible.

I think research is very positive

and I will always be interested

in helping – it’s for the greater


Seven year old Amy took part

in FiCTIoN at Kathryn’s practice.

She has been nervous about

going to the dentist since she

was a toddler. Amy’s mum seized

the opportunity of having more

regular (three monthly) contact

with the dentist to help Amy

overcome her fears. Taking

part in the study has yielded

additional benefits for Amy and

her mum, she says:

“…Keeping a closer eye on her

[teeth] - rather than just every

six months - and also being less

afraid, can only be good things. I

think research in dental practices

is important because treatments

won’t progress unless you do

research – it’s an advantage and

certainly has been for Amy. It

will help change attitudes to

children’s dental care.”

“The NHS has the

capacity to be an

excellent test bed

for large scale trials

in primary care


Oral and dental research is

also reaching out into rural

communities. Timothy Cooke is

a dental practitioner in Nairn (a

rural area of Scotland) and has

a background in public health.

He’s conducting the Interval

study which is investigating the

optimum intervals in between

patient recall appointments.

Despite having a few teething

problems, Timothy is positive

about the advantages of

delivering dental research:

“…it benefits us when we know

the answers to clinical based

questions, and this type of study

will help us. It’s satisfying to

know the answer. Research is

the only way we can find the

answers and participating in

research has also helped to make

my patients more aware about

their dental health, which is

always a positive thing.”

Louise Woodman, who

participated in the Interval study

in Nairn, liked the fact she was

helping to answer a question

that could improve practice:

“They briefly explained what

the study was about and I was

really interested. It made sense

and will make a difference.

Generally research should benefit

you and the wider community.

If [ultimately] it frees up

resources… then it’s better for


Professor Jimmy Steele agrees

and is confident that the

foundations for future research

are now in place:

“The NHS has the capacity to

be an excellent test bed for

large scale trials in primary care

dentistry. Following work over

the last few years, we are now

in a position to use the expertise

we have built to expand our

portfolio of commercial and noncommercial


Dentist Kathryn Houlding with Amy -

patient and study participant

30 | INSIGHT | Autumn 2015

Autumn 2015 | INSIGHT | 31

enal disorders

Local satellite

units lead


renal research

There are over 8,000 people

in the UK undergoing dialysis

for kidney failure. But the

vast majority of care does

not take place in traditional

clinical environments. Insight

magazine spoke to the UK

renal community about

PIVOTAL, a study successfully

engaging far-flung units and

patients in clinical research.

Dialysis requires patients to be connected to a

machine so that their blood can be cleaned, for up to

several hours a day and several days a week. Although

there are over 70 main dialysis centres in the UK,

around 80 per cent of treatment takes place in

a network of satellite units attached to ‘mother’

units. These units reduce the burden of travelling

to and from the dialysis centres, but their remote

location presents challenges when delivering

clinical research.

The PIVOTAL trial was developed as an innovative

collaboration between Kidney Research UK, the UK

Renal Association Anaemia Clinical Study Group,

life-sciences industry and the NIHR. PIVOTAL is

an important study for the UK renal community.

It is the largest clinical trial that has ever been

conducted exclusively in UK renal units, and it is

highly likely that the results will impact on clinical

practice for dialysis worldwide.

For a variety of reasons, dialysis patients often

end up deficient in iron, and this has a number of

important consequences including exacerbating

anaemia, and reducing quality-of-life. Intravenous

(IV) iron injections have therefore been routinely

administered to patients on dialysis for more than

20 years. However, despite its success, the optimal

amount of IV iron that should be given is not

known, and renal units across the UK vary widely

in how much they give their patients.

In 2013, PIVOTAL set about establishing what the

optimum IV iron dosage is. Due to the scale of the

study - 2080 recruits were needed in two years

– Chief Investigator, Professor Iain Macdougall

of King’s College Hospital, recognised the crucial

importance of satellite units for the trial:

Dialysis in the community In addition to 70 'mother' centres around 80 per

cent of dialysis treatment takes place in satellite units around the country

Inset: PIVOTAL patient and carer support group member, Simi Solomon

Research leader: PIVOTAL's Chief

Investigator Professor Iain Macdougall

feels the findings of the study will

have "a widespread impact"

32 | INSIGHT | Autumn 2015

"I’ve never been involved in a

clinical trial before and I hope

that, by being part of the

PIVOTAL study, I can help other

people on dialysis in the UK and

around the world."

“We had to engage the satellite units to

meet our recruitment targets, but this unique

environment did present us with challenges.

“One of the early hurdles was how to

gain consent. Satellite units are staffed by

nurses, but PIVOTAL is a Clinical Trial of an

Investigational Medicinal Product (CTIMP),

and nurses were not allowed to obtain the

consent for this type of study. This is not a

problem in a traditional clinical environment

where the clinician is sited nearby, but

satellite units may be up to 30-40 miles from

the doctors authorised to obtain patient

consent. Unsurprisingly, they do not have

time to travel to and from the unit every time

a patient agrees to take part.”

Professor Macdougall and his colleagues

at King’s Health Partners overcame this

hurdle through an innovative telephone

consent process. It was agreed with the

Ethics Committee that as long as the

research nurse was present to witness the

conversation, the clinician could secure

consent by telephone. As a result, thousands

of patients were able to support the study

who may otherwise have been unable to

take part.

Satellite units are not the only challenge

for kidney research. Despite a significant

number of trials emerging over the last

decade, large-scale trials in dialysis are still

scarce. Professor Phil Kalra, Chair of Clinical

Research Network: Renal disorders, believes

the design of PIVOTAL is an example others

can follow:

“It is difficult to ‘power’ dialysis trials on

hard clinical end-points such as mortality

or non-fatal cardiovascular events as many

different factors are at play in patients with

end stage kidney disease. This was important

when designing the PIVOTAL study which

has clear, realistic, and attainable objectives.

With the excellent support of the UK

nephrology* community, I am confident that

we will complete a dialysis trial which will

help guide future practice.”

The Clinical Research Network has been a

key component in the delivery of PIVOTAL.

Trial Manager, Claire White, explains why:

“Due to the Network’s geographical spread,

it helped us set up sites across England.

Once the hub site was on board, the

research nurses did a substantial amount of

groundwork travelling to units, meeting staff

and explaining the demands of the study.

“Collaborating with the Network also puts

us at the heart of the renal community. The

Network’s Renal disorders Specialty Leads

meet twice a year, which proved useful

during set-up. It enabled us to promote the

study to the right people and maintain the

momentum of site sign-ups.”

One of the first patients to be recruited to

PIVOTAL was Deborah Stevens. She first

experienced kidney problems 14 years ago

and was put on dialysis at the King’s Renal

Unit in Sydenham, south London – a satellite

unit run by King’s College Hospital. Deborah


“I was actually on dialysis when one of

the trial organisers called to tell me about

PIVOTAL and asked me if I wanted to get


“It was quite a coincidence really because I

had been wondering how the doctors knew

how much iron to give to people. It seemed

to me that everyone was getting the same

amount but considering you get different

types of people, I thought a clinical trial like

this might help find out if people do need

different amounts of iron.

“I’ve never been involved in a clinical trial

before and I hope that, by being part of the

PIVOTAL study, I can help other people on

dialysis in the UK and around the world.”

A PIVOTAL patient and carer support group

has also been set up to provide support

throughout the study. This group currently

consists of seven patients and carers who act

as advocates for the project. In the coming

months they will raise awareness of research

with a focus on PIVOTAL in their local areas.

They will provide support and understanding

for patients and research nurses as well

as gathering feedback, particularly from

the patient perspective, to help inform the

research, improve practice and care, and

potentially help boost recruitment into the


As part of the group, Simi Solomon believes

she provides a voice on behalf of all kidney


“Because of my interest in wanting to learn

more about what is happening to me, the

information and knowledge, as well as the

conversations that I have with patients come

from the heart. I hope to be able to be the

voice of enlightenment to patients who are

‘on the fence’ about getting involved in


Professor Macdougall is delighted with

PIVOTAL’s progress and excited at its

potential national and international


“Clearly, the results of the trial will have

widespread impact, and will likely influence

iron management in dialysis patients around

the world. I would personally like to thank

all the principal investigators, research nurses

and study teams throughout the UK for the

commitment and hard work they have put

into the trial thus far.

“This study has not only shown that the UK

can potentially conduct large randomised

controlled trials in patients with chronic

kidney disease, but has allowed a network

of research nurses to collaborate, share

experiences and learn from each other.”

* Nephrology: specialty of medicine concerned

with the study and treatment of kidney problems

Autumn 2015 | INSIGHT | 33


Esther Harris

Clinical Research


Eastern PPIE


Enlisting a Patient and

Public Involvement and

Engagement (PPIE) or lay

representative on a research

team has been relatively

uncommon to date, but

teams in Clinical Research

Network: Eastern have

embraced the chance

to include an alternative

perspective by getting PPIE

representative, Esther Harris,

involved in their research.

Among other projects,

Esther has brought her

invaluable PPIE expertise to

the PERFECTED study. We

asked her to share a bit of it

with Insight.

34 | INSIGHT | Autumn 2015


Tell us about how you became a

PPIE representative in research?

As well as being a nurse, midwife and

health visitor I was a senior lecturer

at City College Norwich. I taught various

subjects, including the research module

for the Diploma of Nursing at Norwich City

College, so I have a fairly significant health

and research background.

With this academic background, I can’t quite

be considered a lay person, but I have always

been interested in my patient and public

viewpoint which personal experience has

contributed to. I thought it would be really

interesting to put the two together, so upon

retirement, I chose to join PPIRes (Patient &

Public Involvement in Research).

I am able to give a perspective which is not

affected by the bias that can sometimes weigh

decisions down and I am also able to add a

view which encompasses the patients’ and the

public’s too.

What does the role of a PPIE

representative involve?

It is my role to consider the course of

research and healthcare from a patient

and public perspective, and to ask the crucial

questions that need asking on their behalf.

If researchers want to put forward a research

proposal, they are usually required to include

a PPIE aspect and one way of doing this is to

ask the PPIRes team for help. PPIRes will send

proposals to a selected list of representatives

which, in Norfolk and Suffolk alone, consists

of around 50 people. Some are simply for a

‘plain English’ review or for commenting on,

some ask me to get involved in pre-proposal

meetings, but I have also been privileged

to sit on various boards and study steering


Can you give me a specific example

drawing on a particular study?

I was introduced to the team working on

the PERFECTED (Peri-operative Enhanced

Recovery hip FracturE Care of paTiEnts with

Dementia) study, which is led by Dr Chris

Fox at the University of East Anglia (UEA), as

I had some experience in dementia research


There were a few contractual hurdles to

overcome and I had to have quite a lot

of training because the research would

be taking place in a hospital. But good

collaboration at management level across

all the organisations involved meant we got

started in good time.

Along with the research team, I carried out

observations on the dementia ward at the

Norfolk and Norwich University Hospital.

Each session lasted around three hours,

during which time I sat and observed the

goings-on on the ward – not what the

patients do, but what the staff do to help

the patients. It was an amazing experience

because I saw things that I never would have

seen in my nurse or auditor roles.

"I am able

to give a


which is not

affected by

the bias that

can sometimes

weigh decisions


The result has been fuller and richer data to

analyse, obtained from perspectives other

than that of a clinician or academic. This

can only contribute to an enriched new

care pathway for hip fracture patients with


What’s been your biggest


Getting clinicians and academics to

understand where patients are coming

from is the ultimate aim of my role, and the

ultimate challenge. Researchers can often

live in a different world from the patient, and

this is a place where I used to live. However,

now that I live in the patient’s world, I am in

a valuable position to tackle that challenge.

I sometimes feel feedback could be a bit

more forthcoming, but I’ve never felt that

I’ve not been listened to. And I don’t think

I’ve been involved in any research where

the academics or clinicians have not been

appreciative of what I’ve said and done.

Why is this Network role important

to you?

I definitely wouldn’t want to be sitting

at home doing nothing! I’ve always

been a professional and I don’t want to stop

being a professional. The skills that I’m using

are those that I’ve acquired during my career

which have been paid for, and studied for.

I’m lucky, as I’ve still got these skills, so I

want to use them.

It not only enhances my learning abilities and

my academic abilities but, on a personal note,

it gives me a sense of confidence knowing I’m

doing something which I consider to be so


What do you like most about your


I love meeting people, I like working

with the professionals and I like to think

that I can make a positive difference to the

course of a research project.

Being involved also opens doors to many

other opportunities. For instance, I have just

been invited to become a Join Dementia

Research Champion in the Norfolk area to

help raise awareness about the efforts being

made to find better treatments for this


I think it’s a fantastic idea for patients and

the public to get involved in research. I was

really, really pleased to be asked, and to

be considered able to do it, so I am really

looking forward to applying my skills to this

next challenge!

Autumn 2015 | INSIGHT | 35

eproductive health and childbirth

Weighing up

the benefits

Regular weighing

of pregnant women

by community midwives is not currently

recommended in the UK but the POPS2

study may change that. The Clinical

Research Network: West Midlands has

been telling Insight magazine why

it might soon be time for pregnant

women to step on the scales.

During pregnancy many women gain too

much weight because they do less physical

activity and eat more food. This can lead

to complications for the mother during

pregnancy and it can also negatively affect

the health of the baby. In addition, weight

gained during pregnancy which is not lost

afterwards could lead to women becoming

obese or starting subsequent pregnancies in

an unhealthy weight state.

The POPS2 trial is investigating the benefits

of regular weighing and weight monitoring

of women throughout pregnancy. The ideal

health professionals to help women do this

are community midwives, since they see

women regularly during pregnancy and their

role is to promote good outcomes for mother

and baby. This meant that the study had to

go beyond the conventional hospital setting.

Despite this potential challenge, Network

support has helped POPS2 to be a resounding

success. Chief Investigator for the trial, Dr

Amanda Daley of Birmingham University,

(pictured) explains:

“This trial is a great example of clinical

research taking place in the wider community

environment. With the support of the

Network, we have been very successful in

engaging community midwives in research;

we have trained 105 community midwives

across four study sites to deliver the


Women are approached and recruited into

POPS2 by the research team, which includes

research midwives,

when they have their 10-

14 weeks dating scan. At

this point a baseline weight

measurement is taken.

Once they have agreed to take part

in POPS2 the women are randomised

to receive the usual care from their

community midwife or usual care plus the

intervention. Those receiving the intervention

are weighed at each routine antenatal visit.

As well as having their weight plotted on a

weight gain chart, a maximum weight gain

limit is set for each subsequent appointment.

The midwives then provide feedback on

weight gain progress and encourage women

to weigh themselves weekly and to check

this against their chart to ensure they do not

exceed their target weight. Brief messages

about the importance of eating healthily and

physical activity during pregnancy are also


Follow up by the research team then takes

place at week 38 of pregnancy to determine

if the women have gained excessive weight

over the study period.

POPS2 is running at four sites in the West

Midlands; Birmingham (lead site), Dudley,

Oxford and Warwick. Over 650 women who

are having a ‘normal’ pregnancy (without

complications at the start of pregnancy) who

are cared for by community midwives have

been recruited to the study – a fantastic

achievement considering the original target

“This trial is a

great example

of clinical


taking place

in the wider



36 | INSIGHT | Autumn 2015

“The success

of the study

so far is due

to the hard

work and


of community


and research

facilitators. ”

Research leader POPS2 Chief Investigator,

Dr Amanda Daley

was to recruit 610 women. Dr

Amanda Daley commends those


“The success of this study so

far is due to the hard work and

commitment of community

midwives and primary care

research facilitators which

allowed us to recruit to target

several months ahead of

schedule. Approaching women

in the community when they

were booked to have the dating

scan was a really efficient

method of recruiting women

and we would definitely consider

using this approach again in any

future studies.”

Research Midwife Paula Trinham

agrees that the straightforward

nature of the study was an


“Because POPS2 is a relatively

simple study for the participants,

this really helped with

recruitment. The ward clerks and

maternity support workers were

also very helpful to us – it was a

real team effort.”

Support from the Network

included funding of the staff

for recruitment - experienced

research midwives and primary

care researcher facilitators

were able to spend time in

the community clinics and

GP surgeries, recruiting and

consenting patients. Working

together with the community

midwives and other clinic staff

the study became part of the

care provided and integrated

easily into the day to day running

of the clinics.

As well as the weight

monitoring, up to 30 women

and 30 community midwives

will be interviewed about their

experiences of participating in

POPS2. For example, the pilot

study for POPS2 suggested that

the intervention does not appear

to cause women to become

anxious and this will be further

investigated. Sue Morris, a

community midwife in Dudley is

also encouraged by how patients

have responded to POPS2:

“A lot of the participants were

really quite positive about it,

and keen to be weighed every


“I think it makes people more

aware of their weight during

pregnancy, so although it’s

something else for us to do,

I think it did have a positive

impact on the ladies and that’s

what we’re all here for isn’t it, at

the end of the day?”

Charis Hadland, aged 33 from

Stourbridge, participated in

POPS2. She reflects on her

personal experience:

“I was very happy to take part

in the trial. I studied sociology at

university, so I’m aware of the

importance of research. It was

no extra effort on my part and

it was very interesting… I will

be interested to see how easily

I go back to my pre-pregnancy

weight. I’m glad I took part and

would be interested to hear

about other trials in future.”

The pilot study for POPS2

showed this type of intervention

to be promising in preventing

excessive weight gain during

pregnancy. The final results

of POPS2 will be available in

February 2016. If it proves

effective this simple, low cost

intervention could be offered to

all pregnant women in the UK

without adding substantially to

antenatal appointment length.

Autumn 2015 | INSIGHT | 37

infectious diseases

Students prove

vital to vaccine


Recruiting 18,000 healthy teenagers

across the UK is no mean feat, yet

the UKMenCar4 study has made it

happen. Insight magazine talks to

CRN: North West Coast about how

they helped to take research out of the

clinic and into the college.

Meningococci are a type of bacteria that

cause serious infections. They are usually

carried harmlessly in the oropharynx (part of

the throat) but sometimes cause devastating

disease which has a high mortality rate if

untreated. Thankfully, it is a largely vaccinepreventable

disease and outbreaks are

uncommon in the UK. But groups of people

that are in continuous close proximity are

more at risk. Students, newly arrived at

college and often sharing both study and

living space, fall firmly into this category.

The UKMenCar4 study is a large scale

multi-centre study of meningococcal

oropharyngeal carriage in 16-19 year

olds. Originally aiming to recruit 18,000

young people over seven months the study

smashed its target reaching a total of 21,800


Clinical Research Network: North West

Coast was one of 11 Local Clinical Research

Networks helping to deliver the study. It

was clear from the outset that recruiting

large numbers of healthy teenagers would

mean extending the reach of research

into unfamiliar territory. Despite the

new environment, over 1000 students in

Lancashire colleges were recruited within a

three week period.

The key to success was simple –

collaboration and communication. The

study posed several challenges; the mere

scale of the study was daunting (it was

the second largest ever conducted in the

Trust) and it was the first study to be run

38 | INSIGHT | Autumn 2015

"By working collaboratively we

have been able to offer research

to a service user group that have

previously been


directly by the Trust’s R&D department. The

recruitment window was small and it was

a completely new recruitment environment

for the research team which depended on

new relationships being formed with three

different colleges.

Carole Kay, Health Coordinator in the Health

Improvement Team, took on the role of

principal investigator. Her team had never

delivered research before, so Carol worked

closely with the Trust. She also secured

the assistance of three college nurses to

provide clinical expertise on site at Burnley,

Accrington and Rossendale, and Nelson

and Colne Colleges – a collaboration which

enabled the timely and efficient collection

of throat swabs on campus. Carole explains

why bringing different skills sets together

was so important:

“This is the first large scale research project I

have worked on. The support and expertise

of the research team, combined with the

college nurses’ skills and knowledge has

enabled an effective, successful outcome to

the study.

“The college nurses understood the

student population, the geography of

the buildings and how to reach as many

students as easily as possible. The research

team had the experience of delivering

research, understanding the governance and

methodology, and [my team] also came with

the clinical skills required for the study.”

The collaborative efforts don’t stop there.

Lancashire Care NHS Foundation Trust

partnered with Lancashire Teaching Hospitals

NHS Foundation Trust to secure pathology

support, and linked up with the Network to

obtain research nurse support to help with

recruitment. All in all, in excess of 25 staff

from the two Trusts and CRN: North West

Coast worked together to secure the study


Getting the college nurses and other staff on

board certainly helped to generate interest

and gain the confidence of the students.

One student in particular became an

ambassador for the study. Nineteen year old

Vince became known as a ‘Research Team

Leader’ during the study because of his

enthusiasm to become involved and to assist

the research team.

Vince started college three years ago on an

entry level course. He found school difficult

because of learning difficulties and personal

issues that impacted on his learning and

emotional health. Being part of the research

effort gave him the chance to be involved in

an important project and to be and effective

member of a team. This has helped to boost

his confidence which was an unforeseen

benefit of becoming actively involved in the

study. His involvement also helped to bridge

gaps between different people involved in

the study.

Karen Palmer, Clinical Research Nurse

Manager for Lancashire Care NHS

Foundation Trust agrees that collaborating in

different and new ways helps to open doors

for research as well as adding value:

“By working collaboratively we have been

able to offer research to a service user group

that have previously been overlooked and

[we have also] raised the profile of our


“Research is a strategic priority for our Trust

and as a department it is imperative that we

seek out opportunities to work together to

achieve [our goals]. When the opportunity

arose to collaborate with the college nurse

team, we were all very keen. Both the

research and college nurse teams came

with a ‘can do’ attitude to making the study

work…[everyone] brought different expertise

to the table… We hope to work together

again on other research studies.”

As a result of the high levels of participation

in the UKMenCar4 study Lancashire Care

NHS Foundation Trust has exceeded its

annual patient participation target by 79 per

cent. In total 1528 patients, service users and

carers have had an opportunity to take part

in research within the Trust.

Furthermore, recommendations for

vaccination against meningococcal disease

have changed this summer. Students

going to University from September 2015

should see their GP for a vaccine against

meningococci serogroups A, C, W and Y.

UKMenCar4 study will form the baseline for

evaluating the effect the new vaccination

programme will have in preventing

meningococcal disease.

Target group Students are at a higher risk of disease caused by meningococci bacteria

Autumn 2015 | INSIGHT | 39

dementias and neurodegenerative diseases

Enriching the lives of residents wit

It is estimated that

dementia affects around

80 per cent of residents

in care homes. With the

number of people with

dementia expected to

double in the next 30

years, research cannot

solely be about finding a

cure, it must also be about

finding the best way to

support people living

with dementia here and

now. Insight magazine

investigates how the NIHR

is tackling this issue.

For care homes, research can directly

and indirectly enhance the quality of life

for residents and provide an opportunity

for professional staff development. For

residents, research gives this vulnerable

population a voice, which is important for

people with dementia who often have

communication difficulties.

The NIHR ‘Enabling Research In Care

Homes’ (ENRICH) programme is the first

national care home research network in

the world. It aims to broaden the research

landscape by encouraging stronger

partnerships between researchers, care

home staff and residents.

Now in its fourth year, the ENRICH

network is flourishing with almost 1,000

care homes on board. Many have now

participated in research at some level by

recruiting to studies, completing surveys

or joining study review groups.

An online toolkit compliments the

programme, detailing how research

works, how to overcome the challenges

faced by care homes and best practice.

Whilst focusing on dementia, the

information provided is transferable to

other disease areas and conditions. The

fourth edition of the toolkit launched

in October and brings the toolkit to life

with blogs, additional case studies and

a community feature allowing users to

share ideas and experiences.

Professor Martin Rossor, NIHR National

Director for Dementia Research, University

College London, explains why the ENRICH

programme is so important:

“We tend to think of research as a

process that takes place in laboratories

with white coats and test tubes, but

research is much broader than that. It

does include the very early laboratorybased

work as well as experimental

medicine and trials in hospitals, but it also

includes research in peoples' homes and

increasingly, in care homes.

“Research in care homes has long been

a Cinderella subject (a less important

part of NHS clinical services), but it is of

major importance for dementia. Up to

80 per cent of people in care homes will

have memory problems, and a substantial

number of patients living with dementia

– perhaps as many as 300,000 – will at

some point live in a care home.”

The Clinical Research Network has fully

supported the ENRICH programme since

inception. Local initiatives are underway

to raise awareness of the programme

and enhance the support available to

care homes across the country. Three

examples follow:

The ENRICH website:

40 | INSIGHT | Autumn 2015

"Research in care homes has

long been a Cinderella subject

(a less important part of NHS

clinical services), but it is of major

importance for dementia"

h dementia

The MARQUE study, 'Managing

Agitation and Raising Quality of life

Agitation is extremely common in people

with dementia and causes distress to

themselves and often their families, as

they don’t know how to help their family

member. Agitation is currently tackled on an

individual basis and is not managed as part

of dementia care.

In response to the Prime Minister’s

'Challenge on Dementia', the MARQUE

project* aims to increase knowledge about

dementia, agitation and the residents’

wellbeing. There are six strands to the

project and one is a study specifically

exploring agitation and quality of life in care


This is the biggest study undertaken in care

homes so far, with nearly 100 care homes

and 3,500 people taking part. Residents and

their families are being surveyed about the

resident’s condition and care received whilst

staff are being surveyed about the care that

they provide.

Professor Gill Livingston is a researcher at

the Mental Health of Older People Unit,

University College London, and is leading the

MARQUE study, she said:

“Working with the Clinical Research

Network has enabled us to extend our reach

and include different types of care homes.

This will give us the best picture of agitation

in a care home setting as we can compare


Flixton Manor is a nursing and residential

care home in Trafford. Lead Clinical Nurse,

Fradreck Mukada, explains why the home

decided to take part in the study:

“We were happy to participate in the study

because it’s about improving resident care.

It’s good to be able to offer research to our

staff, residents and their families because it

gives them an opportunity to feedback and

the results of the study could help to shape

care in the future.”

Collection of study data will complete at

the end of October. Gill and her team look

forward to reviewing the research findings in

the New Year.

*The MARQUE study is funded by the NIHR

and Economic and Social Research Council.


"It’s good to

be able to

offer research

to our staff,

residents and

their families

because it

gives them an

opportunity to

feedback and

the results of

the study could

help to shape

care in the


Helping to shape future care The nursing and residential care home team at Flixton Manor, with

Lead Clinical Nurse, Fradreck Mukada, central right

Autumn 2015 | INSIGHT | 41

dementias and neurodegenerative diseases

Profile: Jill Lindsay, Care

Home Research Facilitator

Jill Lindsay is a Network facilitator from CRN: West

Midlands who introduces care homes to research.

Previously a nurse for 25 years and a research nurse

for three years, Jill now spends two days a week

supporting the ENRICH programme. Insight magazine

caught up with Jill to find out what her new role


What does your role involve?

Ultimately my role is to encourage research activity in care homes,

which for many of them is their first time. Once on board I act

as an advisor, giving guidance and training, preparing them for

opportunities to take part in research. When an opportunity arises

I facilitate communication between the researcher and the care


What do you like most about your job?

I have worked with care homes for several months now and it’s

humbling to see the love, care and interaction between staff,

volunteers and residents. Staff give an awful lot of themselves to

their work and it’s great to assist them in finding the best ways to

support people living with dementia.

What has been your biggest challenge?

Making initial contact and not sounding like a sales person is a

challenge. It’s important that I get across who I am, who I represent,

the importance of

research but above all,

the benefits to the care

home - the majority of

them are businesses

after all, they need to

know how it will benefit

them and the people

they care for.

What has been your

greatest achievement?

I have previously worked

on two dementia studies,

so that experience has

helped me to think

outside the box to make

links with people who

can help me to spread

the word - like specialist

community nurses and

mental health teams. Also, presenting and networking at events has

been key.

What’s next?

This role is still very much in its infancy and it will only grow. The

more care homes that come on board, the more support we will

need to provide. I want to look at new ways of engaging care

homes, building on what I have already learnt and put in place.

I want to reach as many care homes and residents as possible

because if they don’t know about research how can they make a

choice of whether or not to get involved.

“We're really


to see the

impact of


network in


and Humber”

URiCH ‘Understanding

Research in Care Homes’

The Clinical Research Network is going back

to basics in Yorkshire and Humber, working

on a training course to help the ENRICH

network understand the purpose and

process of research.

Due to pilot in November 2015, URiCH,

based on ‘MOOC’ technology (massive

open online course), will help care home

staff learn about research. Topics include

why research is important, how studies are

designed and run, safeguarding, ethics and

the consent process. As staff work through

each section of the course they will receive

a badge in recognition of their new found


After joining the ENRICH programme in July

2013, CRN: Yorkshire and Humber hosted

a training day for care home managers and

local academics. The success of the training

led to the development of the online training

course. Lead Research Nurse, Chris Rhymes

is heavily involved in the build of URiCH, he


“We’re really starting to see the impact

of the ENRICH network in Yorkshire and

Humber. We have recruited 58 care homes

to date and they have really welcomed and

embraced the opportunity to get involved

in research. But with so many care homes

on board and research studies available, we

thought, how are we going to manage the

training of care home staff?”

Once the feedback is implemented from the

pilot, the URiCH MOOC will be rolled out

nationally through ENRICH and publicised via

local government and social websites where

possible to maximise distribution.

42 | INSIGHT | Autumn 2015



Raising awareness

of the benefits of

clinical research in the


Upcoming in 2016:





Stay informed.

Sign up for Clinical Research Network enews:

Guess who’s 10

years old next


2 0 1 6

NIHR at 10

Similar magazines