mHealth Wearables Report 2016SCORR Marketing and Applied Clinical Trials

Overview

Mobile health technologies have great promise to improve clinical trials in the future. These technologies are widely expected to be in greater demand from trial participants who already are comfortable using mobile technology in other areas of their lives. Sponsors, too, may bene�t when these technologies are used to better connect developers with patients, speed the execution of studies and reduce costs.

In a follow-up to our mHealth survey last year, SCORR Marketing, in partnership with Applied Clinical Trials, conducted another survey to delve deeper into mHealth technology, this time with special emphasis on wearable technology. We wanted to know how the industry believes mHealth wearable technology will be used in the next few years and attitudes toward its implementation. Additionally, we wanted to know who is most resistant to wearables and better understand what concerns remain.

Survey respondents include individuals from CROs, pharmaceutical companies, academic institutions, service providers, consultancies, research sites and hospitals. These individuals hold a variety of job titles, including positions as, or in, research and development (R&D), corporate management, clinical directors, strategy or planning, business development, QA/QC, regulatory, medical affairs and clinical research associates.

In this survey, we gathered information on: • Where companies conduct clinical trials • In which therapeutic areas clinical trials are conducted • Companies’ current use of mHealth wearable technology in

clinical trials • Which stakeholders are most resistant to the application

of wearable technology in clinical trials • Attitudes toward present and future use of

wearable technology • Concerns over data security, costs, patient compliance and

environmental factors when applying wearable technology • Ways in which wearable technology will be utilized

in the future

Industry Website(s)48%

Web Search(es)62%

Do the positives of wearables outweigh the negatives?

YES95% NO 5%

YES 91%

NO9%

How do you stay on top of wearable technology?

In 3 years, will your company use wearables more often?

What will they use them for?

In which therapeutic areas has your company conducted trials?

56%Oncology

51%Cardiovascular

5%Drug Delivery

36%Monitoring

60%Both

35%Respiratory

38%Infections and Infectious Diseases

47%Neurology

37%Endocrinology

Applied Clinical Trials70%

Industry Magazine(s)51%

Conference(s)/Trade show(s)43%

12%Sleep Studies

Where does your company currently conduct trials?

84%

32%36% 40%

31%

41%

52%

34%

27%

Which group is most resistant to wearables?

Pharmaceutical Companies

Laboratories 3%

Don't Know 10%

38%

12%Other

Patients 15%

In the past year, have you used a wearable drug delivery device in trials?

In the past year, have you used a wearable monitoring device in trials?

YESNO

41% 59% YESNO

31%

69%

Clinical Sites 22%

Are you familiar with pilot clinical studies using wearables?

YES 52%

NO48%

VERY CONCERNED

27%SOMEWHAT

CONCERNED

42%How concerned are you about data security?

22% 5% VERY

CONCERNED

30%SOMEWHAT

CONCERNEDHARDLY

CONCERNEDNOT AT ALL

CONCERNED

23% 9% HARDLY

CONCERNEDNOT AT ALL

CONCERNED

43%How concerned are you about patient compliance?

Which concerns will not be suf�ciently addressed in the next three years?

26% 5% VERY

CONCERNED

29%SOMEWHAT

CONCERNEDHARDLY

CONCERNEDNOT AT ALL

CONCERNED

40%

35% 58% 38% 33%

How concerned are you about data context?

21% 3% VERY

CONCERNED

26%SOMEWHAT

CONCERNEDHARDLY

CONCERNEDNOT AT ALL

CONCERNED

50%How concerned are you about costs?

Three Main Points:

1.) Respondents overwhelmingly see wearable technology as bene�cial for clinical trials. About 19 in 20 respondents (95%) believe the positives outweigh the negatives. This is true across all types of organizations, all job titles and regardless of where the company headquarters is based.

Interestingly, respondents see this technology as bene�cial despite a fair amount of unfamiliarity with clinical studies using wearables. Only a slight majority of respondents (52%) were familiar with pilot clinical studies being conducted with wearable technology. Regarding clinical trial usage in the past year, less than one in three (31%) respondents’ companies (31%) utilized a wearable drug delivery device, and just two in �ve respondents’ companies (41%) used a wearable monitoring device.

2.) If any group is skeptical about the merits of wearable technology for clinical trials, it is pharmaceutical companies. Respondents were asked which stakeholders are most resistant to the application of wearable technology in clinical trials. By a sizable plurality, pharmaceutical companies (38%) was the group most often identi�ed, followed by clinical sites (22%), patients (15%) and laboratories (3%).

These respondents include those from pharmaceutical companies. More than two in �ve (43%) pharmaceutical companies describe themselves as the stakeholder most reluctant to implement wearable technology. Pharmaceutical company respondents are also the least likely group to be familiar with pilot clinical studies using wearables and the least knowledgeable about their company’s use of wearable monitoring devices during clinical trials.

3.) There are substantial technological and protocol-related concerns that coincide with the use of wearables, but for the most part, respondents believe these concerns will be suf�ciently addressed in the next three years. A majority of respondents are very or somewhat concerned about data security (69%), costs (76%), patient compliance (73%) and environmental factors (how data is affected by context, e.g, whether the patient just ate: 69%). However, about two-thirds of respondents believe technological advances and improved protocols will suf�ciently address all but one of these concerns in the next three years. Environmental factors is the exception, where just two in �ve (42%) respondents believe the concerns will be suf�ciently addressed.

Three Main Points (cont.):

The level of concern is not uniform across all groups. • Regarding data security, respondents in R&D are more than twice as likely (34%) to be very concerned than are clinical directors (16%). Similarly, respondents with company headquarters in the United States are more than twice as likely (31%) to be very concerned than those with company headquarters elsewhere (13%). • Those from academic institutions (36%) were much more likely to be very concerned about costs than are service providers (15%). • CROs are most likely to be very concerned about patient compliance. • Almost half of respondents from CROs (48%) are very concerned about environmental factors, and this group is least likely (24%) to believe technological advances or improved protocols will suf�ciently address these concerns in the next three years.

Other Key Takeaways:

• North America is by far the region most likely to host clinical trials, followed by Western Europe and Russia/Eastern Europe.

• Oncology is the most common therapeutic focus for clinical trials, followed by cardiovascular and neurology.

• Aside from following Applied Clinical Trials, respondentsare most likely to use Web searches to stay informed regarding wearable technology-related issues.

• More than nine in 10 respondents believe that, within three years, their company will utilize wearable technology more than it does currently.

• Of those respondents who expect their company to utilize wearable technology more, about three in �ve believe it will be for both drug delivery and monitoring. More than a third believe they will just do so for monitoring, while about one in 20 believe they will do so for just drug delivery.

continued on next page >

Three Main Points:

1.) Respondents overwhelmingly see wearable technology as bene�cial for clinical trials. About 19 in 20 respondents (95%) believe the positives outweigh the negatives. This is true across all types of organizations, all job titles and regardless of where the company headquarters is based.

Interestingly, respondents see this technology as bene�cial despite a fair amount of unfamiliarity with clinical studies using wearables. Only a slight majority of respondents (52%) were familiar with pilot clinical studies being conducted with wearable technology. Regarding clinical trial usage in the past year, less than one in three (31%) respondents’ companies (31%) utilized a wearable drug delivery device, and just two in �ve respondents’ companies (41%) used a wearable monitoring device.

2.) If any group is skeptical about the merits of wearable technology for clinical trials, it is pharmaceutical companies. Respondents were asked which stakeholders are most resistant to the application of wearable technology in clinical trials. By a sizable plurality, pharmaceutical companies (38%) was the group most often identi�ed, followed by clinical sites (22%), patients (15%) and laboratories (3%).

These respondents include those from pharmaceutical companies. More than two in �ve (43%) pharmaceutical companies describe themselves as the stakeholder most reluctant to implement wearable technology. Pharmaceutical company respondents are also the least likely group to be familiar with pilot clinical studies using wearables and the least knowledgeable about their company’s use of wearable monitoring devices during clinical trials.

3.) There are substantial technological and protocol-related concerns that coincide with the use of wearables, but for the most part, respondents believe these concerns will be suf�ciently addressed in the next three years. A majority of respondents are very or somewhat concerned about data security (69%), costs (76%), patient compliance (73%) and environmental factors (how data is affected by context, e.g, whether the patient just ate: 69%). However, about two-thirds of respondents believe technological advances and improved protocols will suf�ciently address all but one of these concerns in the next three years. Environmental factors is the exception, where just two in �ve (42%) respondents believe the concerns will be suf�ciently addressed.

Three Main Points (cont.):

The level of concern is not uniform across all groups. • Regarding data security, respondents in R&D are more than twice as likely (34%) to be very concerned than are clinical directors (16%). Similarly, respondents with company headquarters in the United States are more than twice as likely (31%) to be very concerned than those with company headquarters elsewhere (13%). • Those from academic institutions (36%) were much more likely to be very concerned about costs than are service providers (15%). • CROs are most likely to be very concerned about patient compliance. • Almost half of respondents from CROs (48%) are very concerned about environmental factors, and this group is least likely (24%) to believe technological advances or improved protocols will suf�ciently address these concerns in the next three years.

Other Key Takeaways:

• North America is by far the region most likely to host clinical trials, followed by Western Europe and Russia/Eastern Europe.

• Oncology is the most common therapeutic focus for clinical trials, followed by cardiovascular and neurology.

• Aside from following Applied Clinical Trials, respondentsare most likely to use Web searches to stay informed regarding wearable technology-related issues.

• More than nine in 10 respondents believe that, within three years, their company will utilize wearable technology more than it does currently.

• Of those respondents who expect their company to utilize wearable technology more, about three in �ve believe it will be for both drug delivery and monitoring. More than a third believe they will just do so for monitoring, while about one in 20 believe they will do so for just drug delivery.