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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 />

EBOOK<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 />

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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 />

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<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 />

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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 />

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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 />

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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 />

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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 />

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