PAPERLESS CLINICAL TRIALS SURVEYSCORR Marketing and Applied Clinical Trials

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In this survey, we gathered information on:• Current levels of paperless data collection

• Perspectives on the importance of paperless clinical trials

• Familiarity with and utilization of eClinical terms and processes

• Processes that have already been adopted

• Benefits and challenges stemming from adoption of eClinical processes

• Stakeholders most resistant to paperless trials

• Predictions on future company and industry adoption of paperless processes

OVERVIEW

An ongoing challenge of conducting clinical trials is finding ways to increase efficiency and reduce costs. A movement toward paperless trials is a potential solution to this challenge. Entering and accessing data electronically rather than manually can increase accuracy, lower costs, reduce data management time and improve productivity.

SCORR Marketing, in partnership with Applied Clinical Trials, recently conducted a survey to better understand the extent to which clinical trials are moving toward paperless processes.

Respondents included individuals from CROs, pharmaceutical companies, academic institutions, consultancies, service providers, research sites, hospitals and medical device companies. These individuals’ job titles or departments include positions as, or in, research and development (R&D), clinical director, corporate management, quality assurance/quality control (QA/QC), clinical research, regulatory, project management, strategy/planning and data management. Sixty percent of the respondents work for U.S.-based companies, 31 percent for companies headquartered in Europe, 3 percent for companies based in Asia and 3 percent for Australian companies.

Note: Some charts, where noted, only include users of paperless technology. These are respondents who reported that their company has adopted at least one paperless process.

My company hasn’t realized any benefits

Faster study startup

Increased audit and inspection readiness

15%

Increased audit and inspection readiness

Better external collaboration

24%

Other

1%

20%

What is the biggest benefit of going paperless?

What are the top realized benefits from going paperless?

Better data quality

Better data quality

38%

50%

Better external collaboration

15%

24%

Cost savings

15%

Cost savings

33%Unsure

15%

There aren’t any benefits to be gained

2%

5%

Other

6%

PAPERLESS CLINICAL TRIALS SURVEY

Faster study startup

4%

Unsure

4%

Disagree Unsure Agree

Greater ease searching for and finding documents

5 16 96

Improved document quality 7 25 82

Increased data quality 7 25 86

More efficient data collection 4 18 101

Reduced need for data entry 26 22 69

Have paperless processes helped your company achieve these benefits?

PAPERLESS CLINICAL TRIALS SURVEY

More than three-quarters of users

say their company’s data collection is more

efficient because of paperless processes.

User responses above.

NO

How important is it that your company move toward paperless trials?

What are the top problems stemming from the adoption

of paperless processes?

Have the positives of going paperless outweighed the negatives?

USERS

YES

UNSURE

NON-USERS

1 2 3 4 5

3 0 2 4 63 6 13 43 58

Responses based on a 5-point scale, 5 representing the highest or the best.

DATA SECURITY CONCERNS 29%

MY COMPANY HAS NOT EXPERIENCED ANY PROBLEMS BECAUSE OF PAPERLESS PROCESSES 27%

DATA QUALITY CONCERNS 13%

WORSE EXTERNAL COLLABORATION 9%

DECREASED PATIENT COMPLIANCE 7%

OTHER 1%

70%

23%

7%

PAPERLESS CLINICAL TRIALS SURVEY

Only user responses above.

USERSWhat has most hindered your company’s adoption of paperless processes?

44%

27%

15%

33%

27%

40%

16%

33%

12%

27%

18%

27%

16%

33%

1%

7%

How do you rate these stakeholders’ acceptance of technologies promoting paperless trials?

NON-USERS

LABORATORIES 3.09

CROs 3.11

THIRD-PARTY SERVICE PROVIDERS 3.00

PHARMACEUTICAL COMPANIES 2.93

CLINICAL SITES 2.68

PATIENTS 2.51

COST OF TECHNOLOGY

LACK OF INTEREST/

LOW PRIORITY

FEAR OF CHANGE

UNSUREMY COMPANY’S ADOPTION OF

PAPERLESS PROCESSES HAS NOT BEEN HINDERED

OTHERLACK OF INTERNAL

SUPPORT/TRAININGREGULATORY

REQUIREMENTS

Responses based on a 4-point scale, 4 representing major acceptance.

PAPERLESS CLINICAL TRIALS SURVEY

GREATER THAN 75%

51-75%41-50%

USERSHow much of your data collection processes are now paperless?

In three years, what percentage of your company’s and industry’s clinical trials will be paperless?

16% 16% 24%8% 12%11% 10%

0-10% 11-20% 21-30% 31-40%

Only user responses above.

INDUSTRYCOMPANY

PAPERLESS CLINICAL TRIALS SURVEY

0%

5%

10%

15%

20%

25%

30%

35%

100%75-99%50-74%25-49%0-24%

Pe

rce

pti

on

Adoption

30%None of these

43%E-signatures on clinical trial documents

In the past year, what processes has your company adopted?

Which of these terms are you familiar with?

A combination of user and non-user responses above.

Only user responses above.

14%mHealth/Wearables for drug delivery/monitoring

21%Electronic patient informed consent

23%EMR for patient recruitment

44%Obtaining trial data source records from EMR

PAPERLESS CLINICAL TRIALS SURVEY

Electronic case report forms (eCRF) 90%

Electronic medical records (EMR) / Electronic health records (EHR)

74%Electronic patient-reported outcomes (ePRO) 62% mHealth/Wearables 32%

Direct electronic data capture (EDC) (NOT dual data entry)

78% Electronic trial master file (eTMF) 71%

Electronic clinical outcome assessments (eCOA) 40% None of the above 3%

1%Other

Not only are these respondents less familiar with mHealth than other

paperless terms, their companies are less likely to use mHealth or wearables

during clinical trials.

THREE MAIN POINTS:

1.) Respondents feel it is important their company move toward paperless clinical trials and believe better data quality is the biggest benefit to be gained. When respondents rated the importance of their company moving toward paperless clinical trials on a 5-point scale (with 5 being extremely important and 1 being not at all important), the average rating overall was 4.14. The average rating was above 4.00 across company types, job titles and company headquarter locations. Those who work in QA/QC feel especially strong about the need to move toward paperless trials (with an average rating of 4.54). Respondents from companies who have adopted at least some form of paperless processes (“users”) had an average rating of 4.20, while those whose companies have yet to adopt paperless processes (or “non-users”) were less enthusiastic (average rating of 3.67) about the importance of moving toward paperless trials.

The most often cited benefit gained by adopting paperless processes is better data quality (named by 50% of users). Among the other benefits realized are cost savings (33%), better external collaboration (24%) and increased audit and inspection readiness (also 24%). Individual users from CROs are more likely to cite cost savings as a benefit (47% of CROs compared to 29% overall). Those from U.S. companies are more than twice as likely to identify increased audit and inspection readiness (29%) as a benefit compared to those with headquarters in Europe (13%).

When specifically asked how paperless processes have helped their data-related goals, respondents overwhelmingly reported that their company’s data collection has become more efficient (79% of users agreed this goal was met). Similarly, those who have adopted paperless processes said they have given their company greater ease searching for and finding documents (75%), better data quality (67%) and improved document quality (also 64%). However, nearly one in five respondents do not feel that paperless processes have reduced their company’s need for data entry; this relative dissatisfaction is reflected especially by individuals from academic institutions (just 43% of users agreed this goal was met) and those in corporate management positions (60%).

2.) Clinical directors say the cost of technology is what most hinders the move toward paperless processes; quality assurance personnel blame a fear of change. When asked what factor most hinders their company’s foray into paperless clinical trials, respondents pointed to the cost of technology (41%); this is most evident among clinical directors (60%). About a quarter of users (27%) also cited fear of change as an obstacle; more than half (54%) of QA/QC personnel did also. Those whose companies have yet to adopt paperless processes were twice as likely to identify a lack of internal support/training as a hindrance (33%) as those whose companies have adopted some paperless processes (16%). On the other hand, a sizable percentage of non-users said their company’s efforts to adopt paperless processes has not been hindered at all (27%); more than one-fourth (26%) of CRO respondents indicated their company has experienced no obstacles.

Problems experienced after adopting paperless processes appear to be infrequent. More than half of users were either unsure that there were any problems (30%) or didn’t believe there were any (27%). More than one-third of those who work at a CRO (39%) said their company has experienced no problems after adopting paperless processes. Of those users who identified problems, the most frequently cited were data security concerns (29%) followed by data quality concerns (13%). Interestingly, users from companies headquartered in Europe were much more likely to identify data security concerns (40%) as a problem than data quality concerns (3%).

Respondents whose companies have adopted paperless processes believe that patients are more hesitant about paperless trials than any other group. When respondents were asked to rate stakeholders’ willingness to undertake paperless processes on a 4-point scale (with a 4 representing major acceptance and a 1 representing major resistance), patients and clinical sites were the groups considered most reluctant, with an average rating of 2.51 and 2.68 respectively. On the other end of the scale, respondents indicate CROs are the most accepting of paperless trials, with an average rating of 3.11. These high ratings were driven markedly by the ratings from respondents with company headquarters in Europe (3.44).

THREE MAIN POINTS (CONT.):

3.) Many respondents — particularly CROs — now rely on paperless processes and also expect their company’s processes to be substantially more paperless within three years. Nearly one in four users (24%) said more than 75% of their clinical trial data collection processes are currently paperless. This proportion is not uniform across all company types; for example, 32% of CRO respondents report this heavy reliance on paperless processes, compared to just 12% of respondents from academic institutions.

This difference between CROs and academia was also evident when respondents were queried about their future plans for paperless processes. About two-fifths of all respondents (42%) predict that 75% or more of their company’s processes will be paperless within three years. About half of CRO (51%) and pharmaceutical company (48%) respondents predict this but only 22% of academia respondents said they would reach mostly paperless in three years. Those in corporate management positions are especially optimistic: Nearly two-thirds (63%) believe that 75% or more of their clinical trial data collection processes will be paperless in the next three years.

Expectations for the industry are not as optimistic. While 42% of respondents believe that 75% or more of their processes will be paperless within three years, fewer (32%) believe the industry’s clinical trials will reach that level in that time frame. Curiously, those at academic institutions are more optimistic (37%) than those working for pharmaceutical companies (26%).

Understandably, non-users were less optimistic about future implementation. More than four in five (81%) predict less than a fourth of their company’s clinical trials will be paperless in three years (compared to 18% for those whose companies have started paperless processes), and about two-thirds (68%) believe that less than half of the industry’s clinical trials will be paperless in three years (compared to 31% for those whose companies have enacted paperless processes).

Other Key Takeaways:

• R&D respondents and clinical directors were more than five times as likely to select cost savings as the biggest benefit to going paperless.

• Of seven common “paperless” terms, respondents were most familiar with electronic case report forms (eCRF) and least familiar with mHealth. CRO respondents were about three times as likely to be familiar with electronic clinical outcome assessments (eCOA) than those from academic institutions. R&D personnel were markedly less likely to be familiar with eCRF or electronic trial master file (eTMF) than other groups.

• Companies in the past year were more likely to have obtained trial data source records or used e-signatures on clinical trial documents than to have used mHealth wearables or electronic patient informed consent.

• Respondents overwhelmingly believe that the positives of paperless processes have outweighed the negatives. This is true across most groups except for QA/QC personnel, the majority of whom were unsure that the positives had outweighed the negatives.