Recruitment and Retention Practices in the CTSAs: Institutional Survey

1. Recruitment and Retention Practices in the CTSAs: Institutional Survey 2010 Clinical Research Management Workshop Recruitment and Retention Taskforce, Regulatory Knowledge and Support Key Function Committee Rhonda G. Kost MD

2. Toni D'Agostino Cheryl Dennison Nancy Dohn Carla Greenbaum Rose Hallarn Rayanne Hildreth Robert Kolb Rhonda G. Kost** Sarah Kukuljan ** Co-Chairs Recruitment and Retention Taskforce, Regulatory Knowledge and Support Key Function Committee • Halia Melnyk • Sabrina Mervin-Blake • Andrea Nassen • Madrid Poultney • Eric Rubinstein** • Jody Sachs • Scott Sicherer • Susan Sonne

3. Background • Assertions of slow/under-enrollment of clinical trials at academic medical centers • Regulatory Knowledge KFC asked to ‘do something about recruitment’ • Recruitment & Retention Taskforce

4. How to evaluate recruitment /retention at CTSAs? • Challenges • Diverse practices within every CTSA • Diverse protocol portfolios across CTSAs • CTSA-specific versus team-specific resources • Research teams as silos • Data in silos • Funded ‘Center’ practices, policies, resources • Sponsored versus non-sponsored studies

5. Methods • Taskforce drafts survey July 2009 - March 2010 Purpose : • To collect data on the current state of recruitment and retention in the consortium • To identify successful models of recruitment and retention, and potential best practices • To develop the basis for recommendations to improve practice

6. Methods • 48 questions about practices, organization, resources, policies, data capture, oversight, performance, and metrics • Comment fields for describing successful practices and evaluation methods • Survey distributed through institutional representatives to Regulatory Knowledge KFC; may submit >1 response • Secondary investigator level survey also developed for CTSAs to capture varied practices at source (phase II)

7. FeasibilityResources PracticesPoliciesPerformance

8. Types of protocols "Sponsored" protocols …… the main decision-making authority lies with industry, pharmaceutical, or other outside collaborators ….. "Non-sponsored" protocols ….. the main decision-making authority ….. is usually held by the Principal Investigator. Studies conducted at a dedicated “center” (e.g. vaccine or cancer center)

9. Results • Survey sent to 46 centers March-April 2010 • 44 Centers returned 46 responses • 80% answered for their CTSA overall • 20% answered for a specific institution

10. Results • 57% said they had no successful practices to share • 22% willing to share Recruitment practices • 2% willing to share Retention practices • 17% willing to share both • 71% interested in learning about both successful recruitment and retention practices • 15 practices cited as ‘valuable’: • 2 tracking recruitment metrics & performance • 3 data-based feasibility assessment practices • 3 use of registries including ResearchMatch • 7 recruitment cores to provide services to researchers

11. Performance FeasibilityResources PracticesPolicies

12. Time elapsed from IRB-approval to enrollment of first participant…. Sponsored Protocols

13. What is the source of the data: 26% IRB records; 30% best guess Q#40

14. How Are Recruitment Target Dates Chosen for Protocols? • Sponsored studies: • 80% Sponsor selects the recruitment date • 9% investigators selects the date • Non-sponsored studies: • 70%, investigators selects recruitment date without specifying the basis • 20% conduct some kind of feasibility assessment The IRB requires feasibility assessments The investigator conducts a feasibility assessment using existing datasets The investigator selects the target date w/o specifying a basis Q#8,11

15. …....the IRB approves the study? Yes - 14 (30%) ……the contract is signed for the study? Yes - 10 (22%); most informal, optional Is there an institutional process to evaluate the feasibility of successfully enrolling a study before…. Q#36, 37

16. Is there a mechanism in place to track/referee whether multiple approved studies at one center are competing for the same patient population? 13% - Don’t know 37% - No 50% - Yes – most often for Cancer Center or special unit only; most are informal

17. How can recruitment feasibility be assessed? • Cleveland Clinic* • University of North Carolina • Duke • Washington University St. Louis* • The Rockefeller University • University of Rochester* • Research Match

18. Q#14 What do you believe are the three most important elements of successful study recruitment at your CTSA?

19. Resources • Registries, databases • Central recruitment services/core • Funding • Expertise

20. How are research participants registered and tracked at your Center? 11 (24%) In an institution-wide database that permits tracking research participants or a research registry 26 (57%) CTSAs report PI or departmental level databases listing research participants Q#30

21. Is there an IRB-approved mechanism to identify and individually contact previous research participants about new research? • 11 (29%) said ‘yes’ • 9 additional comments – limited to PI or protocol specific access, not central

22. Do contracts for Sponsored protocols at your institution/CTSA generally specify funding for the time, effort, and other costs of participant recruitment? 4% No funds 15% Other 6% Ads only 11% Adequate overall 63% Funds, but generally underfunded Q#35

24. Does anyone track whether studies at your institution are meeting enrollment and accrual targets on schedule? PI ? Sponsored protocols Sponsored Protocols Non-Sponsored Protocols Other (IRB) PI Other PI Sponsor PI ? > Annually in house Other > Annually ? > Annually in house IRB IRB Sponsor IRB ? > Annually 2 CTSAs (4.3%) report an entity other than the IRB that tracks accrual more often than annually. Q# 31,32

25. Are there remedies offered by the CTSA/institution for studies that do not accrue within the projected timeline? Q#33

26. Are there penalties applied to Investigators for hosting studies that do not accrue within the projected timeline? Q#34

27. If a Sponsored study underperforms regarding accrual, is there a written policy or standard practice for closing that study? • Sponsor closes the study 9 (20%) • Finance or Utilization Review closes the study 3 ( 7%) • No policy 24 (54%) Q#41

28. If a Non-Sponsored study underperforms regarding accrual, is there a written policy or standard practice for closing that study? • Finance or Utilization Review closes the study 4 ( 8%) • No policy 32 (72%) Q#46

29. In the past 3 years, how many Sponsored protocols have been closed for non-accrual? <5% 3 (7%) 5-10% 2 (4%) No tracking 35 (77%) In the past 3 years, how many Non-Sponsoredprotocols have been closed for non-accrual? <5% 1 (2%) 5-10% 1 (2%) No tracking 35 (77%) Q#42,47

30. Q16 Please name up to three (3) additional activities that you think would enhance Recruitment at your center if they could be provided.

31. Retention practices 96% report no retention planning though What do you think would help retention at your site? (32 respondents provided 73 suggestions) • Increased convenience for participants (locations, parking, hours, guides) • Appreciation, gifts, special calls, experience evaluation, VIP treatment for participants • Core services (registry, advice, evidence-based recruitment plans)

32. What are the opportunities? • Leverage data already being collected (e.g. time elapsed to enrollment, % protocols with on-time accrual; % stopped for non accrual) • Partner with industry in creating realistic, adequately resourced recruitment targets • Provide resources to research teams – training, data, expertise – for planning, negotiating resources • Track activities, performance, and costs at a level where policy and resources can effect change

33. Next Steps… • More detailed analysis of Survey responses • Develop common definitions for tracking recruitment activities, and effectiveness metrics for CTSAs • Create resource library of Recruitment Core procedures, templates, tools, successful practices • Develop a common Recruitment Practice and Outcome Tracking protocol to conduct a consortium-wide study