CLINICAL TRIALS: PAST, PRESENT AND FUTURE

SURVEY REPORT

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OVERVIEWClinical trials have changed dramatically in the last 10 years. Sponsors are increasingly pressured to get drugs to market faster and cheaper while addressing more FDA regulations, a growing number of trials, fierce competition for patients and an increasingly global trial landscape. To offset these costs and get their products to market faster, sponsors are turning in larger and larger numbers to contract research organizations (CROs) to conduct their clinical studies.

To gain a better understanding of the effect of these changes, SCORR Marketing conducted a survey in partnership with Applied Clinical Trials. This summary report delves into how clinical trials have changed and what we can expect as they continue to evolve.

All the participants in this survey have qualified opinions about clinical trials. They come from academic institutions, research sites and contract research organizations, with departments or job titles ranging from project managers and clinical research associates, to clinical directors and data managers. Although most respondents work for companies within North America, there are also many from Europe and Asia. Nearly half the respondents have 20 years or more of experience.

In this report, we provide information about:

• How the roles of clinical research associates, data managers, project managers and regulatory affairs professionals have evolved over time

• Which of these roles has changed the most, and the ones that will continue to change moving forward

• What has led to an increase in adaptive trials, eligibility criteria, endpoints and procedures

• Which factors best explain the increasing complexity of clinical trials

• How patient recruitment and site selection have changed

• Reasons why the patient-site landscape has evolved in the past decade and why it will continue to change

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KEY RESULTSTechnology, collaboration are changing jobsNearly half of respondents (45%) believe that the job of clinical research associates (CRAs) has changed more over the past 10 years than other roles, and this was true across most organization types except research sites. This view was more prevalent in Europe (63%) than it was in North America (37%). Surprisingly, those in project management were as likely to say the role of regulatory affairs professionals changed as much as their own roles, each at 14 percent.

In the future, it appears that CRAs can expect to continue to adapt in their jobs. Respondents in both Europe and North America believe that the role of CRAs will continue to change the most (named by 41% of all respondents). Project managers was the second most selected answer (24%), and especially by those in project management (33%).

Respondents felt that some roles have changed more because of technology, while other jobs have varied because of increased collaboration.

• 33 percent of respondents believe a greater reliance on technology is the main reason behind CRAs’ changing roles.

• 40 percent of respondents believe data managers’ jobs are different mostly because of an increased reliance on technology.

• 38 percent say more collaboration is the main reason project managers’ jobs have changed.

What job has changed/will change the most?

Over the past 10 years

Over the next 5 years

CRA 1st CRA

Data manager 2nd Project manager

Project manager 3rd Data manager

Regulatory affairs professional 4th Regulatory affairs professional

Roles increasingly reliant on technology

Roles requiring more collaboration across functions

CRA Project manager

Data manager Regulatory affairs professional

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KEY RESULTS (CONT)More endpoints and adaptive trials increase complexity While a plurality of survey participants said an increase in endpoints best explains the added complexity of clinical trials over the past 10 years, respondents most often predict an increase in adaptive trials will trigger more clinical trial complexity over the next five years. Forty-three percent of academic institutions and 31 percent of project managers agreed that multiple endpoints best explain the increasing complexity of clinical trials. This notion was considered less true by respondents from CROs (13%) and by clinical research associates/coordinators (11%). The second most selected answer, an increase in eligibility criteria, was favored by those from academic institutions (43%) and research sites (42%). Sponsors were least likely to choose eligibility criteria as a cause of complexity (16%).

What best explains the increase in _____ over the past 10 years?

Adaptive trials Faster determination to terminate futile studies

Eligibility criteria Target population criteria

Endpoints More goals in addition to primary study goals

Procedures Questionnaires and subjective assessments

When respondents were asked why the following have increased over the past 10 years, here were their responses:

Increase in Adaptive Trials

• 44 percent thought faster decisions to terminate futile studies was the reason behind the growth in adaptive trials.

• 22 percent indicated the promise of higher drug approval rates made an impact.

Increase in Eligibility Criteria

• 41 percent of respondents chose target population criteria.

• 32 percent selected endpoint success. Increase in Endpoints

• 58 percent thought having more goals in addition to primary study goals is responsible for the rise in the number of endpoints.

• 15 percent said more data needed explains the growth in endpoints. Increase in Procedures

• 42 percent indicated questionnaires and subjective assessments play a factor.

• 32 percent said lab tests and blood work are the primary reasons.

An increase in which of these best explains why clinical trials have/will

become more complex?

Over the past 10 years

Over the next 5 years

Endpoints 1st Adaptive trials

Eligibility criteria 2nd Endpoints

Adaptive trials 3rd Eligibility criteria

Procedures 4th Procedures

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KEY RESULTS (CONT)Upcoming patient-site landscape less clear Experience affects perspective; those who have worked longer view and predict things differently than their less experienced peers. Respondents with 20+ years of experience are more likely to say that the ability to use electronic health records for patient identification will best explain how the patient-site landscape will change in the next five years.

On the flip side, respondents with less experience are more likely to say that clinical research as a care option (CRCO) and direct-to-patient trials will best explain change.

How will the patient-site landscape will change the most in the next 5 years?

Respondents’ experience Response

1-10 yearsTie: (1) Clinical research as a care option (CRCO)(2) Direct-to-patient trials

11-20 years Biomarker data for patient identification

20+ years Ability to use EHRs for patient identification

Other conflicting views about how the patient-site landscape will change in the next five years:

• CRAs and CRCs (32%) are four times more likely to choose CRCOs than are those in project management (8%).

• North American respondents are more than twice as likely (28%) than are those from Europe (11%) to identify direct-to-patient trials.

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OTHER KEY TAKEAWAYSWhat has most changed these roles in the past 10 years?

CRA Data manager Project managerRegulatory affairs

professional

Expanded need for communication skills 9% 10% 13% 10%

Greater access to and handling of reports 4% 7% 9% 9%

Increased reliance on technology 33% 40% 9% 14%

More collaboration across functions 20% 12% 38% 19%

More risk-based monitoring (RBM) 33% n/a n/a n/a

More data quality assurance responsibilities n/a 28% n/a n/a

More proactive mindset required n/a n/a 30% n/a

Greater focus on value-added tasks n/a n/a n/a 10%

More regulations to track n/a n/a n/a 38%

Other 1% 2% 1% 0%

More than any other reasons, an increased reliance on technology and more data quality assurance responsibilities have affected the role of data managers, survey participants said. For project managers, more collaboration across functions and the need for a more productive mindset have led to changes in their job functions.

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OTHER KEY TAKEAWAYS (CONT)What best explains the increase in the number of adaptive trials over the past 10 years? Faster determination of futility to terminate

Promise of higher drug approval rates

Greater use of research site expertise

Potentially fewer patients

Other

0% 10% 20% 30% 40% 50%

A plurality of survey participants said that a faster decision to terminate futile studies best explains the increase in the number of adaptive trials. Those with more experience (20+ years) were more likely to do so than those with fewer than 10 years on the job.

Why has the number of eligibility criteria grown over the past 10 years?

Patient input into protocol design

Biomarker screens

Endpoint success

Target population criteria

Behavior screens

Other

41%

32%

15%

7%

3%3%

Target population criteria plays a key role in the rise in the number of eligibility criteria. This is especially the view of those who work at academic institutions or research sites.

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OTHER KEY TAKEAWAYS (CONT)Why has the number of endpoints risen over the past decade?

More goals in addition to primary study goals

More data needed

Wider scientific scope

Greater risk management

Other

0% 10% 20% 30% 40% 50% 60%

Nearly three in five respondents indicated that more goals, in addition to primary study goals, best explain the increase. European respondents were especially inclined to believe this.

How is the increase in the number of procedures best explained?

OtherRoutine examsImagingLab tests and

blood work

Questionnairesand subjective

assessments

5%4%

16%

32%

42%

0

10

20

30

40

50

According to the survey respondents, the prevalence of questionnaires and subjective assessments leads to an increase in the number of procedures. Those who work at CROs are most likely to support this contention.

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OTHER KEY TAKEAWAYS (CONT)

How has patient recruitment evolved over the past decade?

0% 10% 20% 30% 40%

Other

More outsourcing to patient recruitment service companies

Increased competition for patients

Advent of patient networks and advocacy groups

Greater use of social media

The increase in social media usage has played a big part in the differences behind how clinical trial patients are recruited. Sixty-four percent of research site survey participants share this view, as do more than half of respondents from North America.

What is the primary reason site selection changed over the past decade?

Emergence of siteless trials

Transition from site-centricto patient-centric models

Increased competition for sites

Greater use of social media

Other

56%28%

6%6%

4%

According to survey respondents, the increased competition for sites is the primary reason why the selection process has changed. This is true regardless of experience but especially so for those who have the most experience in the industry.

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OTHER KEY TAKEAWAYS (CONT)What best explains how the patient-site landscape has changed?

44%41%

6%4% 3%

1%

Increased useof patient-

basedtechnology

Greater use of CROs by sponsors

Patient recruitment

changes

Increased use of non-

patient-based technology

Site selection changes

Other0%

10%

20%

30%

40%

50%

Respondents overwhelmingly chose increased use of patient-based technology and greater use of CROs by sponsors. CRAs/CRCs are twice as likely to identify increased use of patient-based technology over greater use of CROs by sponsors, while those in project management are twice as likely to select CRO usage over technology.

What factors will influence how the patient-site landscape will evolve over the next five years?

Biomarker data for patient identification 29%Ability to use EHRs for patient identification 26%

Direct-to-patient trials 22%Clinical research as a care option (CRCO) 19%

Other 3%

According to respondents, increasing use of biomarker data and of electronic health records are the top factors influencing the patient-site landscape over the next five years.