Insights on Digital Health Technology Survey 2016
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EBOOK<br />
<str<strong>on</strong>g>Insights</str<strong>on</strong>g> <strong>on</strong> <strong>Digital</strong><br />
<strong>Health</strong> <strong>Technology</strong><br />
<strong>Survey</strong> <strong>2016</strong>:<br />
How <strong>Digital</strong> <strong>Health</strong> Devices and Data<br />
Impact Clinical Trials<br />
Industry’s Leading <strong>Digital</strong> <strong>Health</strong> Platform
Table of C<strong>on</strong>tents<br />
01 Executive Summary<br />
09 Selecting the Right Endpoint<br />
02 Key Findings<br />
10 Bringing in the Benefits<br />
03 Demographics<br />
04 The Role of <strong>Digital</strong> <strong>Health</strong><br />
Technologies in Clinical Trials<br />
04 <strong>Digital</strong> Data: From Mobile<br />
Apps to Wearables<br />
12 Clinical Outcomes: Which<br />
Therapeutic Areas Offer the<br />
Biggest Impacts<br />
13 The Challenges of <strong>Digital</strong> <strong>Health</strong><br />
15 Summary and C<strong>on</strong>clusi<strong>on</strong>s<br />
06 The Role of <strong>Digital</strong><br />
<strong>Health</strong> Technologies<br />
16 References<br />
07 The Business Drivers<br />
Behind <strong>Digital</strong> <strong>Health</strong><br />
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Executive Summary<br />
The digital health revoluti<strong>on</strong>—aided by the growth in c<strong>on</strong>nectivity, the<br />
global availability of smartph<strong>on</strong>es and the decreasing size of sensors to<br />
make wearables smaller and more discrete—has provided drug developers<br />
access to a wealth of real-world, participant-generated data that<br />
is enabling better insights and streamlined clinical trial processes.<br />
Developing drugs is a challenging process. Only around <strong>on</strong>e in 10<br />
drugs in Phase 1 actually make it through to the market. 1 This high<br />
attriti<strong>on</strong> rate is <strong>on</strong>e factor c<strong>on</strong>tributing to the high costs of drug development.<br />
According to the Tufts University Center for the Study of Drug<br />
Development, developing a drug from bench to market costs an estimated<br />
$2.6 billi<strong>on</strong>. 2<br />
Late-stage clinical trials make up a large porti<strong>on</strong> of those costs, as they<br />
involve larger numbers of patients and can run for l<strong>on</strong>ger durati<strong>on</strong>s of<br />
time. This means recruitment and retenti<strong>on</strong> of patients and the collecti<strong>on</strong><br />
of high quality data is absolutely vital.<br />
In clinical trials, patients are carefully selected to meet ultra-specific<br />
criteria and their adherence to the treatment regimen is closely m<strong>on</strong>itored.<br />
This is not the case outside of trials in the real world, where life<br />
gets in the way and people are all shapes and sizes, doses are missed<br />
and other c<strong>on</strong>diti<strong>on</strong>s can exacerbate disease progressi<strong>on</strong>.<br />
Due to these variables, real-world outcomes may not reflect those<br />
seen during study c<strong>on</strong>duct. In light of this reality, regulators, payers and<br />
providers are increasingly demanding real-world data that dem<strong>on</strong>strates<br />
the efficacy of the drug in the everyday world.<br />
Against that backdrop, Validic c<strong>on</strong>ducted a survey of the BioPharma<br />
Dive readership, including 166 biopharma and life sciences industry<br />
researchers, executives and technology/software professi<strong>on</strong>als to<br />
provide insight into the benefits and challenges of using digital health<br />
data and devices in clinical trials.<br />
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Key Findings<br />
1. The use of digital technologies is growing: Over 60 percent of<br />
survey resp<strong>on</strong>dents stated they have used digital health technologies<br />
in clinical trials and an impressive 97.4 percent plan to use<br />
digital technologies more in clinical trials in the next five years.<br />
2. Applicati<strong>on</strong>s are moving from mobile apps to wearables: The most<br />
comm<strong>on</strong>ly used devices in clinical trials currently are mobile apps<br />
and in-home clinical grade devices. Future use is likely to focus more<br />
<strong>on</strong> wearable activity trackers and sensors. This maps to increased<br />
use of these types of devices by c<strong>on</strong>sumers. Less than 3 percent<br />
stated they would not use devices and digital data in the future.<br />
3. The roles of digital data are changing: Currently, the use of digital<br />
health technologies is mostly focused <strong>on</strong> recruitment, remote patient<br />
m<strong>on</strong>itoring and medicati<strong>on</strong> adherence. There is some use in postmarket<br />
research and fostering patient communities. One hundred<br />
percent of resp<strong>on</strong>dents saw technology as improving medicati<strong>on</strong><br />
adherence. Patient communities are expected to be <strong>on</strong>e of the<br />
biggest growth areas.<br />
4. Business is driving digital health: Three of the biggest drivers<br />
selected by resp<strong>on</strong>dents—reducing trial costs, streamlining trial<br />
processes and dem<strong>on</strong>strating real-world efficacy—are all driven by<br />
the bottom line: cutting drug development costs and ensuring an<br />
adequate return <strong>on</strong> investment. Patient-centricity, the increased focus<br />
<strong>on</strong> the patient experience, is also a key driver.<br />
5. Finding the right endpoint is key: More than two thirds of individuals<br />
surveyed thought improving medicati<strong>on</strong> adherence was the most<br />
important outcome for drug developers, as patient recruitment and<br />
retenti<strong>on</strong> are challenges across clinical development.<br />
Real-time informati<strong>on</strong>, flagged by over half<br />
of resp<strong>on</strong>dents as <strong>on</strong>e of the top benefits of<br />
digital data, supports early decisi<strong>on</strong>-making in<br />
drug development.<br />
6. Real-time data access is an important benefit: Real-time informati<strong>on</strong>,<br />
flagged by over half of resp<strong>on</strong>dents as <strong>on</strong>e of the top benefits<br />
of digital data, supports early decisi<strong>on</strong>-making in drug development.<br />
This frees up drug developers and sites to m<strong>on</strong>itor the resp<strong>on</strong>ses of<br />
patients more closely.<br />
7. Chr<strong>on</strong>ic disease remains important: Chr<strong>on</strong>ic c<strong>on</strong>diti<strong>on</strong>s, particularly<br />
cardiovascular disease and metabolic disorders, are a focus<br />
for many pharma and biotech companies because of the size of the<br />
market and the increasing aging populati<strong>on</strong>. Seven in 10 of those<br />
surveyed thought digital health data could have the greatest impact<br />
in improving care for chr<strong>on</strong>ic disease populati<strong>on</strong>s.<br />
8. Challenges remain: The use of digital data and devices in clinical<br />
trials is still relatively new. Resp<strong>on</strong>dents were most c<strong>on</strong>cerned about<br />
the accuracy of data generated by digital health devices.<br />
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Demographics<br />
The survey received resp<strong>on</strong>ses from 166 people. Over 40 percent<br />
of resp<strong>on</strong>dents were from pharma and biotech companies, with the<br />
remaining resp<strong>on</strong>ses coming from c<strong>on</strong>tract research organizati<strong>on</strong>s and<br />
technology and software providers.<br />
Because of the specialized skill set needed to source and analyze<br />
digital data, many companies are outsourcing this part of the drug<br />
development process. These results reflect the Cutting Edge<br />
Informati<strong>on</strong> 2015 survey that found that around 70% of companies<br />
were outsourcing their data capture, and about half were outsourcing<br />
its analysis. 3<br />
70%<br />
60%<br />
50%<br />
40%<br />
30%<br />
20%<br />
10%<br />
0<br />
64%<br />
North<br />
America<br />
What is your regi<strong>on</strong> of operati<strong>on</strong>s?<br />
23%<br />
Global<br />
5% 3% 3% 3%<br />
Central and<br />
Eastern Europe<br />
Asia<br />
Western<br />
Europe<br />
Central or<br />
South America<br />
What kind of company do you work for?<br />
57% 43%<br />
CRO, TECH<br />
PROVIDER,<br />
OTHER<br />
What is your role with the company?<br />
31% Executive leadership<br />
23% Clinical operati<strong>on</strong>s<br />
15% Innovati<strong>on</strong><br />
13% Sales<br />
10% Marketing<br />
08% IT<br />
PHARMA/<br />
BIOTECH<br />
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The Role of <strong>Digital</strong> <strong>Health</strong> Technologies in<br />
Clinical Trials<br />
As technology becomes more accessible and affordable, the role of<br />
digital health data is growing in clinical trials. As of September 2015,<br />
there were at least 299 clinical trials using wearables, according to<br />
Bloomberg. 3 Supporting that increased prevalence, two thirds of survey<br />
resp<strong>on</strong>dents have already used digital health technologies in clinical<br />
trials, and almost all expect to increase their use within the next 5 years.<br />
<strong>Digital</strong> Data: From Mobile Apps to Wearables<br />
Mobile apps and in-home clinical-grade devices were used most<br />
comm<strong>on</strong>ly in clinical trials, closely followed by wearable activity trackers<br />
and sensors.<br />
Mobile apps, which are downloaded to tablets or smartph<strong>on</strong>es, are<br />
likely to be accepted by trial participants given higher levels of familiarity<br />
with apps. In 2015, almost two thirds of people in the U.S. owned<br />
a smartph<strong>on</strong>e and almost half owned a tablet. 4,5 <strong>Health</strong>-related apps <strong>on</strong><br />
smartph<strong>on</strong>es are also very popular.<br />
Do you plan to utilize digital<br />
health technologies more over<br />
the next 5 years?<br />
Have you used digital<br />
technologies in clinical trials?<br />
97%<br />
YES<br />
3%<br />
NO<br />
64%<br />
YES<br />
36%<br />
NO<br />
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In a survey c<strong>on</strong>ducted in June 2015, 58 percent of smartph<strong>on</strong>e users<br />
had downloaded a health-related app, and 41 percent had downloaded<br />
more than 5 apps. These included diet and physical activity trackers and<br />
apps that help people to learn exercises. 6<br />
In-home clinical grade devices, such as heart rate, blood pressure and<br />
blood sugar m<strong>on</strong>itors, can provide teams running clinical trials with<br />
accurate and reliable data. If these devices are c<strong>on</strong>nected via Wi-Fi or<br />
Bluetooth, this data can be accessed in real time.<br />
However, the vast majority of clinical devices are not currently<br />
Bluetooth-enabled. New technology leveraging optical character<br />
recogniti<strong>on</strong> (OCR), such as Validic’s VitalSnap, can help overcome this<br />
100%<br />
80%<br />
60%<br />
40%<br />
20%<br />
0<br />
What kinds of digital technologies have you included or<br />
would like to include in trials? Select all that apply.<br />
67%<br />
33%<br />
Wearable<br />
activity<br />
trackers<br />
Would like to include in future trials<br />
55%<br />
45%<br />
In-home clinicalgrade<br />
devices<br />
(glucometer,<br />
blood pressure<br />
cuff, etc.)<br />
64%<br />
36%<br />
Sensors<br />
(injectable<br />
sensors,<br />
sensor-enabled<br />
pill bottles,<br />
syringes etc.)<br />
Have included in trials<br />
53%<br />
47%<br />
Mobile apps<br />
75%<br />
25%<br />
I have not<br />
used digital<br />
technologies<br />
in trials<br />
This technology gives researchers the ability<br />
to integrate digital health data from the<br />
n<strong>on</strong>-c<strong>on</strong>nected devices that are already<br />
clinically validated and being used in the trial.<br />
challenge. It enables users to capture health data from n<strong>on</strong>-c<strong>on</strong>nected<br />
medical devices via their smartph<strong>on</strong>e’s camera, and the data are automatically<br />
transferred to the clinician. This technology gives researchers<br />
the ability to integrate digital health data from the n<strong>on</strong>-c<strong>on</strong>nected<br />
devices that are already clinically validated and being used in the trial.<br />
Wearable activity trackers, which are already used in trials by around<br />
a fifth of resp<strong>on</strong>dents, can range from those similar to the c<strong>on</strong>sumer-grade<br />
devices to sophisticated, FDA Class II accelerometers.<br />
Wearables can be as small and as unobtrusive as a Band-Aid. MC10’s<br />
tiny adhesive biostamp, for example, incorporates flexible circuits,<br />
allowing for size reducti<strong>on</strong>s to the point the wearer hardly feels it. 3 The<br />
presence of such trackers can also trigger reminders to be sent to<br />
patients to take drugs as required by the study.<br />
Resp<strong>on</strong>dents were enthusiastic about the growing use of devices,<br />
with <strong>on</strong>ly a small number saying that they would not use devices in the<br />
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future. While the use of in-home clinical grade devices and mobile apps<br />
looks stable, the growth is expected to be in wearable activity trackers<br />
and in sensors.<br />
To be effective, and to ensure that people c<strong>on</strong>tinue to use them, any<br />
digital devices must be easy to learn and use, particularly for the senior<br />
populati<strong>on</strong>, who are most likely to have chr<strong>on</strong>ic c<strong>on</strong>diti<strong>on</strong>s. Things to<br />
take into account include f<strong>on</strong>t size, color, size and shape of butt<strong>on</strong>s,<br />
size of screens and the user’s experience of technology. This could<br />
also include incorporating the technology into something that is already<br />
familiar, such as a watch, clothing or c<strong>on</strong>tact lenses. It is important,<br />
though, not to make assumpti<strong>on</strong>s about the senior populati<strong>on</strong> and their<br />
use of technology – in 2015, 30 percent of Americans ages 65 or older<br />
owned smartph<strong>on</strong>es, 55 percent owned a computer and 32 percent<br />
owned a tablet. 5<br />
Providing a benefit to the user will also increase effectiveness.<br />
Supplying patients with feedback <strong>on</strong> disease status or reminders to take<br />
medicati<strong>on</strong>s, as well as ways to access informati<strong>on</strong> and educati<strong>on</strong> about<br />
the drug and/or illness, can increase engagement with digital health<br />
devices, creating a positive feedback loop.<br />
The Role of <strong>Digital</strong> <strong>Health</strong> Technologies<br />
Currently, the use of digital health technologies is mostly focused <strong>on</strong><br />
recruitment, remote patient m<strong>on</strong>itoring and medicati<strong>on</strong> adherence, with<br />
some use in post-market research and fostering patient communities.<br />
Patient recruitment for clinical trials can be challenging, particularly<br />
in rare diseases where the communities of patients are small. Using<br />
digital communicati<strong>on</strong> and analysis of digital health data can allow<br />
researchers to find the individuals for their clinical trials and widen the<br />
trial’s geographic reach. C<strong>on</strong>tract research organizati<strong>on</strong>s may also have<br />
their own repositories of patients who have already been involved in<br />
past trials and who may be willing to take part again. This speeds up<br />
recruitment and allows prescreening for specific inclusi<strong>on</strong> and exclusi<strong>on</strong><br />
criteria. An example of this is Quintiles’ ‘<strong>Digital</strong> Patient Unit.’ 7<br />
100%<br />
Have you used or would you like to use digital technologies<br />
for the following applicati<strong>on</strong>s? Select all that apply.<br />
Would like to use<br />
Have used<br />
80%<br />
60%<br />
54%<br />
57%<br />
68%<br />
61%<br />
74%<br />
In 2015, 30% of Americans ages 65 or older<br />
owned smartph<strong>on</strong>es, 55% owned a computer<br />
and 32% owned a tablet.<br />
40%<br />
20%<br />
0<br />
46%<br />
Subject<br />
recruitment<br />
43%<br />
Remote<br />
patient<br />
m<strong>on</strong>itoring<br />
32%<br />
Post-market<br />
research<br />
39%<br />
Medicati<strong>on</strong><br />
adherence<br />
26%<br />
Patient<br />
communities<br />
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These communities also support l<strong>on</strong>g-term follow-up, which feeds<br />
into post-market research. Other sources of post-market digital health<br />
data include analysis of electr<strong>on</strong>ic medical records to track physicians’<br />
prescribing patterns.<br />
The Business Drivers Behind <strong>Digital</strong> <strong>Health</strong><br />
The cost of drug development c<strong>on</strong>tinues to escalate, meaning the<br />
market prices of innovative drugs, particularly biologics, are often very<br />
high. As a result of this, payers, providers and c<strong>on</strong>sumers want proof of<br />
the value and cost effectiveness. If payers and c<strong>on</strong>sumers have to pay<br />
a high price, they want c<strong>on</strong>firmati<strong>on</strong> that the drug does what the developer<br />
says, both in clinical trials and in the real world. This need for a<br />
dem<strong>on</strong>strati<strong>on</strong> of efficacy and real-world value is <strong>on</strong>e of the key drivers<br />
behind the implementati<strong>on</strong> of digital health.<br />
Clinical trials are costly. In order to ensure a return <strong>on</strong> investment and<br />
an ability to invest in future research and development, companies are<br />
c<strong>on</strong>tinually trying to reduce trial costs and streamline trial processes.<br />
Resp<strong>on</strong>dents to the survey selected these as key drivers for uptake of<br />
digital health.<br />
By automating the collecti<strong>on</strong> of data through digital health devices and<br />
apps, researchers have access to more accurate and objective data,<br />
and quicker. This allows companies to focus clinical trial staff <strong>on</strong> more<br />
productive parts of projects, such as patient support or data analysis.<br />
Improving the collecti<strong>on</strong> of data streamlines clinical trial processes, ultimately<br />
helping to get drugs to market quicker.<br />
What of the following are the key business<br />
drivers for using digital health at your<br />
company? Select all that apply.<br />
73%<br />
68%<br />
Dem<strong>on</strong>strate efficacy and realworld<br />
value<br />
Reduce trial costs<br />
68% Patient-centricity<br />
59%<br />
46%<br />
35%<br />
Streamline trial processes<br />
Precisi<strong>on</strong> medicine<br />
Competitive differentiator<br />
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Remote data collecti<strong>on</strong> from digital health devices has the potential<br />
to reduce the number of site visits, which lowers the need to provide<br />
transport or reimburse travel costs. It also lightens the burden of clinical<br />
trial involvement for patients, as they w<strong>on</strong>’t need to spend as much<br />
time traveling or miss other commitments, such as work, as often. This<br />
c<strong>on</strong>tributes to the patient-centricity of the study—another key driver<br />
highlighted in this survey.<br />
Pers<strong>on</strong>alized or precisi<strong>on</strong> medicine<br />
is increasingly becoming part of<br />
everyday treatment.<br />
Patient-centric clinical trials can also be achieved by listening and<br />
resp<strong>on</strong>ding to patients within digital communities, from patient forums<br />
to Twitter and Facebook. While the analysis of this kind of free text data<br />
is challenging, it helps companies to understand what patients’ unmet<br />
needs are, and what will help them to stay compliant. Data mining<br />
and analytics companies can m<strong>on</strong>itor these kinds of c<strong>on</strong>versati<strong>on</strong>s<br />
and carry out analyses that provide companies with better insight. 8<br />
Patient-reported outcomes, where patients are encouraged to enter<br />
their own data and c<strong>on</strong>tribute to endpoints that are more relevant to<br />
their everyday experiences, could help improve patient engagement,<br />
although questi<strong>on</strong>s remain about accuracy.<br />
Pers<strong>on</strong>alized or precisi<strong>on</strong> medicine is increasingly becoming part of<br />
everyday treatment, as more targeted drugs move through clinical trials<br />
and <strong>on</strong>to the market. Investment into pers<strong>on</strong>alized medicine is also<br />
growing, headlined by President Barack Obama’s nati<strong>on</strong>al Precisi<strong>on</strong><br />
Medicine Initiative. 8<br />
Access to digital health data is helping pharma companies develop<br />
targeted medicines by increasing their understanding of who their<br />
target patients are and helping them access small subgroups of<br />
patients. <strong>Digital</strong> health devices also allow researchers to run what are<br />
effectively <strong>on</strong>e pers<strong>on</strong> clinical trials, where informati<strong>on</strong> from a lot of n=1<br />
studies is collated and aggregated, potentially identifying treatment<br />
97% of resp<strong>on</strong>dents believe that digital<br />
technology will improve clinical trial<br />
cost effectiveness.<br />
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egimens for subsets of patients, or supporting development of drugs<br />
for rare diseases. 8<br />
Almost all of the resp<strong>on</strong>dents felt that digital health technology could<br />
improve the cost-effectiveness of clinical trials.<br />
Selecting the Right Endpoint<br />
<strong>Digital</strong> health devices and sensors can collect a variety of different types<br />
of data. One of the most challenging parts of clinical trials is ensuring<br />
patients adhere to trial protocols. This includes taking the drug at the<br />
right time (morning, afterno<strong>on</strong>, evening), under the right c<strong>on</strong>diti<strong>on</strong>s<br />
(before or after meals) and at the right intervals and number of doses<br />
(<strong>on</strong>e tablet three times daily, or three tablets <strong>on</strong>ce daily). Reflecting that<br />
reality, medicati<strong>on</strong> adherence was the most comm<strong>on</strong>ly chosen endpoint<br />
resp<strong>on</strong>dents wished to measure with digital health technologies.<br />
C<strong>on</strong>sumer grade activity trackers, such as Fitbit and Garmin, are<br />
comm<strong>on</strong>ly used by people who want to m<strong>on</strong>itor their own health and<br />
activity levels. But these c<strong>on</strong>sumer grade devices are increasingly<br />
being used in clinical trials as well. As of June <strong>2016</strong>, there were 104<br />
completed, current or pending Fitbit studies in the ClinicalTrials.gov<br />
website, including studies in obesity, diabetes and cancer.<br />
Due to user-friendly designs and features, including paired apps,<br />
these activity trackers tend to be more appealing to c<strong>on</strong>sumers, which<br />
increases the likelihood of l<strong>on</strong>g-term usage of and engagement with<br />
the device. Many activity trackers can also m<strong>on</strong>itor sleep and heart rate,<br />
and some can also m<strong>on</strong>itor blood pressure, which are all endpoints that<br />
between 51 percent and 59 percent of resp<strong>on</strong>dents felt were important.<br />
What endpoints would you like to measure<br />
with digital health technologies? Select all<br />
that apply.<br />
72% Medicati<strong>on</strong><br />
adherence<br />
oximetry<br />
39% Pulse<br />
67% Activity<br />
59% Heart rate<br />
54% Blood<br />
pressure<br />
51% Sleep<br />
46% Glucose<br />
33% Weight<br />
28% Breathing<br />
28% Temperature<br />
23% Nutriti<strong>on</strong><br />
23% Spirometry<br />
10% Smoking<br />
EBOOK <str<strong>on</strong>g>Insights</str<strong>on</strong>g> <strong>on</strong> <strong>Digital</strong> <strong>Health</strong> <strong>Technology</strong> <strong>Survey</strong> <strong>2016</strong>: How <strong>Digital</strong> <strong>Health</strong> Devices and Data Impact Clinical Trials 9
Blood glucose is an important measure for people with both Type 1<br />
and Type 2 diabetes, and its tracking is important in studies both in<br />
treatment and preventi<strong>on</strong>. There are a number of digital health devices<br />
that can record data <strong>on</strong> blood glucose for home and clinical trial use,<br />
allowing m<strong>on</strong>itoring that can help assess outcomes and provide feedback<br />
for patients, especially those using insulin. Between a third and a<br />
quarter of resp<strong>on</strong>dents were interested in data <strong>on</strong> breathing, spirometry,<br />
nutriti<strong>on</strong> and weight.<br />
Bringing in the Benefits<br />
Around half of the resp<strong>on</strong>dents picked real-time informati<strong>on</strong> as the<br />
most important benefit of digital health data. Getting real-time results<br />
from a clinical trial provides visibility into how the trial is progressing and<br />
flags any problems. This can allow early interventi<strong>on</strong>s (if allowed by the<br />
trial protocol).<br />
Just under 25 percent of resp<strong>on</strong>dents felt digital data helped identify<br />
early signs of disease progressi<strong>on</strong>. Iterative or adaptive clinical trials<br />
allow modificati<strong>on</strong> of the parameters of the study based <strong>on</strong> observati<strong>on</strong>s<br />
allowing for changes to dose or timing, the recruitment of different<br />
populati<strong>on</strong>s, or an early halt to a trial due to success or failure.<br />
Access to real-time data will help inform these kinds of decisi<strong>on</strong>s.<br />
Knowing when to stop a trial early is also important in more traditi<strong>on</strong>al<br />
randomized c<strong>on</strong>trolled trials as well, as it reduces the risk of harm to<br />
patients. This kind of data also allows companies to make rapid go/<br />
no-go decisi<strong>on</strong>s about whether to c<strong>on</strong>tinue development of a drug,<br />
which saves R&D m<strong>on</strong>ey and allows selecti<strong>on</strong> of a subsequent drug<br />
candidate to proceed more quickly. This early decisi<strong>on</strong>-making was<br />
seen as a benefit by more than <strong>on</strong>e in 10 resp<strong>on</strong>dents.<br />
What are the 3 most important benefits of<br />
digital data?<br />
49%<br />
39%<br />
36%<br />
Real-time informati<strong>on</strong><br />
Automated and objective<br />
data collecti<strong>on</strong><br />
Remote m<strong>on</strong>itoring<br />
There are a number of digital health devices<br />
that can record data <strong>on</strong> blood glucose for<br />
home and clinical trial use, allowing m<strong>on</strong>itoring<br />
that can help assess outcomes and provide<br />
feedback for patients, especially those<br />
using insulin.<br />
EBOOK <str<strong>on</strong>g>Insights</str<strong>on</strong>g> <strong>on</strong> <strong>Digital</strong> <strong>Health</strong> <strong>Technology</strong> <strong>Survey</strong> <strong>2016</strong>: How <strong>Digital</strong> <strong>Health</strong> Devices and Data Impact Clinical Trials 10
<strong>Digital</strong> health devices, providing real-world insights and allowing the<br />
collecti<strong>on</strong> of previously unattainable real-world data, can also help<br />
support the development of pragmatic clinical trials. These evaluate<br />
the effectiveness of interventi<strong>on</strong>s in c<strong>on</strong>diti<strong>on</strong>s more like the real world,<br />
not so much if and how a treatment works, but whether it works in<br />
everyday use. 9<br />
The automati<strong>on</strong> of data collecti<strong>on</strong> was chosen as an important benefit<br />
by almost 40 percent of resp<strong>on</strong>dents. Being able to collect data automatically<br />
and c<strong>on</strong>tinuously reduces errors in transcripti<strong>on</strong> by either the<br />
clinical trial staff or the patient and lowers the workload of both groups.<br />
Automated data collecti<strong>on</strong> also helps people who have cognitive<br />
or physical impairments that inhibit their ability to manually record<br />
outcomes. Real-world and pragmatic studies can be expensive. But<br />
the cost saving benefits of digital health data, such as the automated<br />
data collecti<strong>on</strong> and remote m<strong>on</strong>itoring could potentially offset these<br />
higher costs.<br />
Remote m<strong>on</strong>itoring also opens up clinical trials to patients who otherwise<br />
would not be able to take part, because they live too far from<br />
clinical trial centers, or who have physical, visual or cognitive impairments<br />
that mean they struggle with transport. This is reflected by the<br />
quarter of participants who selected ‘reduced office visits for participants’<br />
as an important benefit to digital health adopti<strong>on</strong>.<br />
100%<br />
80%<br />
60%<br />
40%<br />
20%<br />
0<br />
Have you seen a return <strong>on</strong> investment for<br />
your use of digital health data?<br />
67%<br />
It is still too<br />
early to tell<br />
23%<br />
Yes<br />
10%<br />
I’m not using<br />
digital health<br />
technologies<br />
Remote m<strong>on</strong>itoring also opens up clinical trials<br />
to patients who otherwise would not be able<br />
to take part.<br />
0%<br />
No<br />
Despite the apparent (and realized) benefits, it is still relatively early<br />
days for many companies in the world of digital health data. While a<br />
quarter of resp<strong>on</strong>dents have seen a return <strong>on</strong> investment, two thirds<br />
have stated that it is still too early to tell, which is largely due to the fact<br />
that digital health technologies haven’t been used in trials very l<strong>on</strong>g and<br />
drug development cycles are <strong>on</strong> average 10 years. On a more positive<br />
note, no resp<strong>on</strong>dents answered ‘no’ to the questi<strong>on</strong>, Have you seen a<br />
return <strong>on</strong> investment for your use of digital health data?<br />
EBOOK <str<strong>on</strong>g>Insights</str<strong>on</strong>g> <strong>on</strong> <strong>Digital</strong> <strong>Health</strong> <strong>Technology</strong> <strong>Survey</strong> <strong>2016</strong>: How <strong>Digital</strong> <strong>Health</strong> Devices and Data Impact Clinical Trials 11
As well as saving m<strong>on</strong>ey, another route to improving return <strong>on</strong> investment,<br />
or at least covering additi<strong>on</strong>al costs, is using a digital health<br />
device or app as part of value-added services post launch. These can<br />
improve coverage by payers or providers by improving the cost-effectiveness<br />
of a particular drug, as well as driving better adherence,<br />
resulting in <strong>on</strong>going income from repeat prescripti<strong>on</strong>s.<br />
<strong>Digital</strong> health devices have an obvious role<br />
to play in clinical trials of chr<strong>on</strong>ic disease as<br />
they can m<strong>on</strong>itor changes over l<strong>on</strong>g periods<br />
of time.<br />
Clinical Outcomes: Which Therapeutic Areas Offer<br />
the Biggest Impacts<br />
<strong>Digital</strong> health devices have an obvious role to play in clinical trials of<br />
chr<strong>on</strong>ic disease as they can m<strong>on</strong>itor changes over l<strong>on</strong>g periods of time.<br />
This is reflected in the finding that almost three-quarters of resp<strong>on</strong>dents<br />
selected chr<strong>on</strong>ic c<strong>on</strong>diti<strong>on</strong>s as <strong>on</strong>e of the areas where digital health<br />
will make the biggest impact. It also reflects the prevalence of chr<strong>on</strong>ic<br />
diseases in the U.S., which affect around half of all adults in the U.S. and<br />
are behind seven of the 10 leading causes of death. Around 86 percent<br />
of the healthcare spend in the U.S. is <strong>on</strong> chr<strong>on</strong>ic disease. Rising levels<br />
of these types of c<strong>on</strong>diti<strong>on</strong>s is <strong>on</strong>e of the drivers behind the <strong>on</strong>going<br />
increases in direct and indirect health costs. 10<br />
The predominance and significance of chr<strong>on</strong>ic disease is also exhibited<br />
in the selecti<strong>on</strong> of cardiovascular disease by almost two thirds of<br />
resp<strong>on</strong>dents and metabolic diseases by over half. CNS disorders were<br />
selected as a key therapeutic area by half of the resp<strong>on</strong>dents, while <strong>on</strong>e<br />
in three selected <strong>on</strong>cology.<br />
Aging populati<strong>on</strong>s mean an increase in cognitive diseases such as<br />
Alzheimer’s disease and other forms of dementia. In resp<strong>on</strong>se, more<br />
companies are c<strong>on</strong>ducting clinical trials to look at therapeutics that can<br />
treat or reverse cognitive decline. Wearables and remote m<strong>on</strong>itoring<br />
<strong>Digital</strong> health devices also play a role in clinical<br />
studies for preventi<strong>on</strong> of chr<strong>on</strong>ic disease.<br />
EBOOK <str<strong>on</strong>g>Insights</str<strong>on</strong>g> <strong>on</strong> <strong>Digital</strong> <strong>Health</strong> <strong>Technology</strong> <strong>Survey</strong> <strong>2016</strong>: How <strong>Digital</strong> <strong>Health</strong> Devices and Data Impact Clinical Trials 12
will play an important role in providing data from people whose age and<br />
cognitive deficits would otherwise make participati<strong>on</strong> difficult.<br />
<strong>Digital</strong> health devices also play a role in clinical studies for preventi<strong>on</strong><br />
of chr<strong>on</strong>ic disease, for example lifestyle factors such as diet and lack of<br />
exercise that increase the risk of obesity, diabetes and cancer.<br />
On the other hand, a third of resp<strong>on</strong>dents selected acute c<strong>on</strong>diti<strong>on</strong>s<br />
as an area which could benefit from greater adopti<strong>on</strong> of digital health.<br />
Data generated from digital devices could be particularly helpful for<br />
proving the value of some of the newer curative therapies for serious<br />
infecti<strong>on</strong>s by recording outcomes over l<strong>on</strong>ger periods. As an example,<br />
Gilead’s antiviral, Solvadi (sofosbuvir), hit the headlines because of its<br />
$84,000 price tag when it was approved by the U.S. Food and Drug<br />
Administrati<strong>on</strong>. Sovaldi is a potentially curative treatment for hepatitis<br />
C, effective in around 90 percent of cases. According to data from the<br />
PwC <strong>Health</strong> Research Institute, while the initial cost is indeed high, the<br />
savings over the patient’s lifetime due to better health should easily<br />
offset the high costs. 11<br />
The Challenges of <strong>Digital</strong> <strong>Health</strong><br />
The use of digital health data and devices in clinical trials is still relatively<br />
new, and drug developers have c<strong>on</strong>cerns about the challenges these<br />
new technologies will bring. Chief am<strong>on</strong>g resp<strong>on</strong>dents’ c<strong>on</strong>cerns was<br />
data accuracy. Looking at rank order, with 1 being the top c<strong>on</strong>cern, the<br />
greatest c<strong>on</strong>cern is the accuracy of data. This is frequently a worry for<br />
new technologies and is <strong>on</strong>e which should be alleviated as technology<br />
improves.<br />
In which therapeutic areas will digital health be<br />
most impactful? Select all that apply.<br />
73%<br />
63%<br />
53%<br />
47%<br />
34%<br />
34%<br />
Chr<strong>on</strong>ic c<strong>on</strong>diti<strong>on</strong>s<br />
Cardiovascular disease<br />
Metabolic disorders<br />
CNS disorders including<br />
Alzheimer’s disease<br />
Acute c<strong>on</strong>diti<strong>on</strong>s<br />
Rare diseases<br />
32% Oncology<br />
21%<br />
Musculoskeletal disorders<br />
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<strong>Digital</strong> health is growing fast, and there are many device manufacturers<br />
working in the space. This makes it difficult to discern which technologies<br />
are most appropriate for the clinical trial setting. The resp<strong>on</strong>ses to<br />
the survey reflect this c<strong>on</strong>fusi<strong>on</strong>.<br />
Once data has been collected, it is important to know whether it is standardized<br />
and can be integrated into clinical trial platforms and systems.<br />
Otherwise, the data is either impossible to use or costly to analyze.<br />
Physicians can be reluctant to use digital<br />
health devices, feeling inundated with pitches<br />
to use this app for that drug or <strong>on</strong>e device<br />
for another study. This could hinder wider<br />
adopti<strong>on</strong> of digital technologies.<br />
1<br />
Accuracy of data<br />
2<br />
Standardizati<strong>on</strong><br />
of data<br />
3<br />
How to analyze<br />
the data in a<br />
meaningful way<br />
What are the key c<strong>on</strong>cerns you have when it comes to using<br />
digital health data? (Rank order, 1 being the top c<strong>on</strong>cern.)<br />
4<br />
Knowing what device<br />
to use<br />
5<br />
Integrating data from<br />
devices into your<br />
clinical trial platform<br />
or system<br />
6<br />
Patients’ ability and<br />
willingness to use<br />
digital health devices<br />
9<br />
21 CRF Part 11<br />
compliance<br />
7<br />
Physicians’ ability and<br />
willingness to use<br />
digital health devices<br />
8<br />
Lack of guidance<br />
from the FDA <strong>on</strong><br />
devices<br />
10<br />
I’m afraid digital health<br />
data will dem<strong>on</strong>strate<br />
negative results for the<br />
drug or therapy<br />
11<br />
I’m afraid the FDA will<br />
reject trials results<br />
that include digital<br />
health data<br />
EBOOK <str<strong>on</strong>g>Insights</str<strong>on</strong>g> <strong>on</strong> <strong>Digital</strong> <strong>Health</strong> <strong>Technology</strong> <strong>Survey</strong> <strong>2016</strong>: How <strong>Digital</strong> <strong>Health</strong> Devices and Data Impact Clinical Trials 14
Physicians can be reluctant to use digital health devices, feeling inundated<br />
with pitches to use this app for that drug or <strong>on</strong>e device for<br />
another study. This could hinder wider adopti<strong>on</strong> of digital technologies.<br />
Companies should therefore emphasize ease of use for digital health<br />
tools, incorporating benefits for the physician as well as the patient.<br />
Summary and C<strong>on</strong>clusi<strong>on</strong>s<br />
Advances in digital health devices and data could allow drug developers<br />
to carry out more detailed and real time analyses of data from<br />
clinical trials. This has the potential to increase the speed at which drugs<br />
progress through clinical trials, as well as accelerating decisi<strong>on</strong>-making<br />
by companies <strong>on</strong> which programs to pursue. While digital health<br />
remains new, with attendant c<strong>on</strong>cerns about how the resulting data can<br />
be used, there is significant optimism over how a digital revoluti<strong>on</strong> could<br />
transform drug development.<br />
Advances in digital health devices and data<br />
could allow pharma and biotech companies to<br />
carry out more detailed and real time analyses<br />
of data from clinical trials.<br />
EBOOK <str<strong>on</strong>g>Insights</str<strong>on</strong>g> <strong>on</strong> <strong>Digital</strong> <strong>Health</strong> <strong>Technology</strong> <strong>Survey</strong> <strong>2016</strong>: How <strong>Digital</strong> <strong>Health</strong> Devices and Data Impact Clinical Trials 15
References<br />
1<br />
Hay M, Thomas DW, Craighead JL, et al., Clinical development success rates for investigati<strong>on</strong>al<br />
drugs. Nat Biotechnol2014. 32(1): p. 40-51. 10.1038/nbt.2786.<br />
2<br />
DiMasi JA, Grabowski HG,Hansen RW, Innovati<strong>on</strong> in the pharmaceutical industry: New estimates<br />
of R&D costs. J <strong>Health</strong> Ec<strong>on</strong> <strong>2016</strong>. 47: p. 20-33. 10.1016/j.jhealeco.<strong>2016</strong>.01.012.<br />
3<br />
Edney A,Chen C. Big Pharma Hands Out Fitbits to Collect Better Pers<strong>on</strong>al Data. Bloomberg,<br />
14 September 2015. Available from: http://www.bloomberg.com/news/articles/2015-09-14/<br />
big-pharma-hands-out-fitbits-to-collect-better-pers<strong>on</strong>al-data.<br />
4<br />
Smith A. U.S. Smartph<strong>on</strong>e Use in 2015. PewResearchCenter, 1 April 2015. Available from: http://<br />
www.pewinternet.org/2015/04/01/us-smartph<strong>on</strong>e-use-in-2015/.<br />
5<br />
Anders<strong>on</strong> M. The Demographics of Device Ownership. PewResearchCenter, 29 October 2015.<br />
Available from: http://www.pewinternet.org/2015/10/29/the-demographics-of-device-ownership/.<br />
6<br />
Pai A. <strong>Survey</strong>: 58 percent of smartph<strong>on</strong>e users have downloaded a fitness or health app.<br />
Mobi<strong>Health</strong>News, 5 November 2015. Available from: http://mobihealthnews.com/48273/<br />
survey-58-percent-of-smartph<strong>on</strong>e-users-have-downloaded-a-fitness-or-health-app.<br />
7<br />
Sharma NS, Patient centric approach for clinical trials: Current trend and new opportunities.<br />
Perspect Clin Res2015. 6(3): p. 134-8. 10.4103/2229-3485.159936.<br />
8<br />
Schork NJ, Pers<strong>on</strong>alized medicine: Time for <strong>on</strong>e-pers<strong>on</strong> trials.Nature 2015. 520(7549): p. 609-11.<br />
10.1038/520609a.<br />
9<br />
Patsopoulos NA, A pragmatic view <strong>on</strong> pragmatic trials. Dialogues Clin Neurosci 2011. 13(2): p.<br />
217-24.<br />
10<br />
Kvedar JC, Fogel AL, Elenko E, et al., <strong>Digital</strong> medicine’s march <strong>on</strong> chr<strong>on</strong>ic disease. Nat Biotechnol<br />
<strong>2016</strong>.34(3): p. 239-46. 10.1038/nbt.3495.<br />
11<br />
LaMattina J, Forgotten In The Sovaldi Price Debate: Hep-C Patients And <strong>Health</strong>care Savings.<br />
Forbes 2014.<br />
EBOOK <str<strong>on</strong>g>Insights</str<strong>on</strong>g> <strong>on</strong> <strong>Digital</strong> <strong>Health</strong> <strong>Technology</strong> <strong>Survey</strong> <strong>2016</strong>: How <strong>Digital</strong> <strong>Health</strong> Devices and Data Impact Clinical Trials 16
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