Mike Stevens - France in the United Kingdom

Mike StevensChief Scientist OfficeScottish Government

NHS RESEARCH SCOTLAND:Partnership in Action1. Partnership within the NHS2. Partnership with Industry3. Partnership with Universities

OLDER PARTNERSHIP“Auld Alliance”•Negotiated in Paris in 1295•Primarily a military alliance•BBC History Website:“ …it was based on a long-establishedfriendship founded on the Scots loveof French wine.”

OLDER PARTNERSHIP“Auld Alliance”•Negotiated in Paris in 1295•Primarily a military alliance•BBC History Website:“ …it was based on a long-establishedfriendship founded on the Scots loveof French wine.”•Plus ça change….

Background• 11.5% of UKhealthresearchexpenditure inScotland(UKCRC, 2012)• Scotland has8.5% of UKpopulation

Scottish Health Service• 14 Territorial Health Boards responsible forprovision of health services within their area– primary and secondary care• Health Boards report directly to, and areaccountable to, Scottish Ministers• Responsibility for Health is devolved to theScottish Parliament• Changes to the NHS being implemented inEngland do not apply in Scotland• Scotland manages its NHS research activityseparately through NHS Research Scotland

UK DimensionFunding:• UK ResearchCouncils• Health Departmentscollaborate onfunding initiativesGovernance:• Unified ResearchEthics System• Common ResearchGovernanceFramework

Challenges for Delivery“However, access topatient data for research iscurrently hampered by afragmented legalframework, inconsistencyin interpretation of theregulations, variableguidance and a lack ofclarity amonginvestigators, regulators,patients and the public”

• Managed through monthly NRS Board meetings: CSO + 4R&D DirectorsNHS Research Scotland(NRS)• Partnership between CSO & the Health Boards inScotland.• Created after consultation with NHS R&D Offices– valued the direct working relationship with CSO and– wanted to work through existing R&D structures• Aim is– to agree & implement national policy, and– to deliver greater efficiency to the NHS R&D and Research Ethicsfunction through Pan-Scotland working.• Utilises existing staff: to date only 6.5 additional staffemployed for NRS functions

NHS Health Boards

NHS Research ScotlandRegional working – 4 hubs- Ethics- R&D permissionsNRS ENRS PCCNRS NENRS FunctionsGrampian –NRS Permissions CCGlasgow – NRS IT lead (SReDA)Lothian – NRS Contractual Issuesand National training.Tayside – NRS Governance Issuesand national SOPsNRS WNRS WNRS SE

NRS Priorities1. Efficient Multicentre Permissions2. Fast Site Initiation/Study Start-up3. Improve recruitment to target

Approval Time (Working days)605040302053 534641Multicentre Study R&D Permission TimeNon-Commercial32 3324 2428 2621 2024 2416 172123 22 2115 1618 19MeanMedian1814100Fe b -J une 0 8J ul y -D e c 0 8J a n -J une 0 9J ul y -D e c 0 9J a n -M a r c h 10A pr i l -J une 10J ul y -S e pt 10Oc t o -D e c 10J a n-M a r c h 11A pr i l -J une 11J ul y -S e pt 11Oc t o -D e c 11J a n -M a r c h 12

Approval Time (Working days)Multicentre Study NHS R&D Permission TimeCommercialMeanMedian30252015172119 19 19 19 191615 16252120161814222122181050M a y - D e c09J a n -M a r c h 10A pr i l -J une 10J ul y -S e pt 10Oc t o -D e c 10J a n-M a r c h 11A pr i l -J une 11J ul y -S e pt 11Oc t o -D e c 11J a n -M a r c h 12

NRS Permissionscommercial feedbackNo. of feedback questionnairesreceived = 61Unacceptable Poor Acceptable Good ExcellentAvailability (NRS PCC personnel)? 3 26 30Competence (NRS PCC personnel)? 1 4 26 28Helpfulness/attitude/flexibility (NRSPCC personnel)?11938Helpfulness/attitude/flexibility ofR&D Office staff?61726Overall experience of the process? 1 5 26 28

2. Fast SiteInitiation/Study Start-upCommercial:• Median from NHS Permission to first subjectrecruited– 72 calendar days in 2010– 32 calendar days in 2011Commercial Recruitment to target:• Remains the single biggest problem we have:76% of target patients for completed studies in2011/12.• Significant number of “legacy” studies wheretargets were “optimistic” and recruitment notmanaged.

CSO Strategic InvestmentScotland’s BiomedicalBackboneDundeeClinical Research CentreHealth Informatics Centre&MemoCRUK laboratoriesAberdeenIMSIAHSCRFGlasgowBHFGCRCBiomedical Research CentreIntegrated CRFBeatson Oncology CentreSackler InstituteEdinburghWellcome CRFInstitute Med Cell Biol•Purpose built basic biomedical research institutes.•Integrated general clinical research facilities.

Key Delivery UnitsNHS Research ScotlandClinical ResearchFacilitiesTissue acquisitionserviceBiorepositories‘Safe Havens’Health informaticsresearchProject managementQuality & FacilitationResearch imagingplatform2008 Aim: To reconfigure by March 2012 ~ £10M paof funding to underpin ~ 188 whole time equivalentposts to meet current and future needs.

NRS InfrastructureCore research dedicated staff in NHS86 WTE staff2009/10£4.5m189 WTE staff2010/11 2011/12£10mWTECRF nurses/admin 63Biorepository29Research Imaging 26Informatics Research 16Quality/ Governance 22Clinical trials support 33Investing for the future, not just current needs

Ambition - Tissue• Scotland has taken a light touch non-statutoryapproach to collection, storage and use of tissue• All NHS tissue collections being brought withinone of four approved NRS biorepositories– Aim is to publish a national catalogue of tissuecollections available for research– National arrangements in place for co-ordinatedcollection of fresh tissue– National access to pathology archive• Should be in place by December

Surplus TissueGeneric, enduring consent for use of surplus tissuePilot of e-Form at the surgical pre-assessment clinic-NHS GG&C (GRI), Golden Jubilee, Ayrshire & Arran(97% positive response)

Ambition - eHealth• Enable electronic linkage of healthcareinformation to enhance study phenotypicinformation.– Conduct feasibility assessments.– Cost effective mechanism of enhancing scientificvalue of clinical trials, cohorts, tissue samples andimages (Stratified medicine)– Support epidemiology and pharmacoepidemiologystudies as well as studies of the natural history ofdisease.– enable long term follow up of patient outcomes.

Community HealthNumber07 10 64 02 5 0Date of BirthSex Check

Linkable NHS RecordsCollecting data from cradle to grave …Dental SMR13Mental HealthSMR04Community care SMR50Neonatal Record SMR11Out patients SMR00Hospital Admissions SMR01BIRTHGP consultationsMaternityImmunisationPrescribingScreeningCancer registryDEATHChild health surveillanceCancer registrations SMR06

NRS Safe HavensSAFE HAVENStorage Area NetworkNHS Data StoresPrescribingMortality(GROS)Secure storagepower protectioncamera surveillanceDumb terminalsIntegrated datasetsNHS staffAccredited academic staffHospital episodes(SMR: ISD)Identification(CHI)laboratoryphenotype(SCI store)Imagingphenotype(PACS)Primary Care

Percentage with event0 2 4 6 8 10 12 14 16WoSCPS Study• West of Scotland Coronary Prevention Study –randomised clinical trial in 6,600 men with hypercholesterolemia withno history of miocardial infarction• Linkage of prescribing data and morbidity records(electronic pharmacovigilance)PlaceboOriginaltrialPravastatin0 2 4 6 8 10 12 14 16Years since randomisation

Effect of SmokingLegislation - ScotlandAdmissions fell by 17% - 67% of reduction was in non-smokersFall in England 4% (no legislation); long term trend 3%Pell et al, N Eng J Med (2008) 359; 482-491

NHS RESEARCH SCOTLAND:Partnership in Action1. Partnership within the NHS2. Partnership with Industry3. Partnership with Universities

Partnership with Industry• Critical to successful delivery of studies• Contrary to traditional wisdom, delays arecreated by both the NHS and industry• NRS Industry Partnership Forum createdto identify and remove barriers to efficientdelivery of trials• Evidence suggests working as partners,rather than as separate contractingparties, delivers better results andremoves barriers

Partnership with Industry• Strategic Collaboration between PPD(CRO) and NHS Research Scotlandannounced in February 2012• Quintiles (CRO) announced 2 weeks agothat NHS Research Scotland will be one ofits Global Prime Sites• Other less formal partnerships beingdiscussed with pharma

NHS RESEARCH SCOTLAND:Partnership in Action1. Partnership within the NHS2. Partnership with Industry3. Partnership with Universities

Health Science ScotlandCompeting on a global scaleNHS BoardsUniversitiesWorldClassPatientcareExcellenceInLifeSciencesTranslationalMedicine &Clinical Trials

Health Science ScotlandAim: To build enduring, or time-limited, collaborativepartnerships that offer critical mass and innovativesolutions in clinical and translational research.Builds on• Translational Medicine Research Collaboration, a £50mcollaboration with Wyeth Pharmaceuticals on biomarkerdiscovery and translational models• Now being progressed through Pfizer Grand Challengeprogramme for biomarker discovery in key disease areas(£3 million investment).• Scotland’s academic research excellence – 2009 Reportfound Scotland’s research is cited by other researchersaround the world more than any other country (relative toGDP)

Stratified Medicine ScotlandInnovation Centre…the right treatment, to the right patient at the right time…

Stratified Medicine ScotlandInnovation Centre• Scottish Funding Council call forInnovation Centres to support “sticky”collaborations with Industry• HSS Stratified Medicine proposal seeks toestablish programmes in key diseaseareas of interest to industry• Through linking NHS patient data withphenotypic and genotypic data, become aleading centre for specialist stratifiedmedicine clinical trials

Stratified MedicineScotlandInnovation CentreSMS Operational Model and PartnersPharmaceuticals/CROGSK/Novartis/Quintiles/Astra ZenicaHealth Science ScotlandNHS PartnersNHS Safe HavenBiorepositoryHealth Science ScotlandAcademic PartnersGenetics, omics, biomarker discoveryBiostatistics, Health InformaticsStratified MedicineScotlandDiagnostics companiesAlere/AxisShield/ArrayjetLead CompanyAridhiaBioinformatics & FinanceBiopta/Syntropharma/Sistemic/DestiNATherapeutics/Service SMEsLead companyLife TechnologiesNext Generation SequencingTechnology Access & FinanceFiosBioinformatics SMEs

Stratified Medicine Scotland –Business ModelCompanyAExemplar Programme 5: RespiratoryExemplar Programme 4: Rheumatology/InflammationExemplar Programme 3: Demyelination/NDExemplar Programme 2: Cardiovascular/DiabetesExemplar Programme 1: Oncology – Lung/PancreasTissue/Bio-repositories/DatasetsBiomedical Informatics/e HealthCompanyCompanyCImagingBGenomic/”omic’ medicineInnovation Centre Business PlatformLeadership, Governance and Public Engagement, Business & Supplier DevelopmentTraining, Capacity Building and Knowledge Exchange , Industry/Policy Interaction

Stratified Medicine ScotlandInnovation Centre•Should know the outcome by end of thismonth•But already creating good and enduringpartnerships with Industry; substantialinvestmentalready committed in support of this initiative

Mike StevensChief Scientist OfficeScottish GovernmentChief Scientist Office – http://www.cso.scot.nhs.ukNHS Research Scotland – http://www.nhsresearchscotland.org.ukHealth Science Scotland – http://www.healthsciencescotland.com