Accrual and Recruitment Practices at Clinical and Translational Science Award (CTSA) Institutions: A Call for Expectations, Expertise, and Evaluation

Kost, Rhonda G. MD; Mervin-Blake, Sabrena MSCR; Hallarn, Rose; Rathmann, Charles; Kolb, H. Robert RN; Himmelfarb, Cheryl Dennison RN, ANP, PhD; D’Agostino, Toni MA; Rubinstein, Eric P. JD, MPH; Dozier, Ann M. RN, PhD; Schuff, Kathryn G. MD, MCR

doi: 10.1097/ACM.0000000000000308
Research Reports

Purpose: To respond to increased public and programmatic demand to address underenrollment of clinical translational research studies, the authors examined participant recruitment practices at Clinical and Translational Science Award (CTSA) sites and make recommendations for performance metrics and accountability.

Method: The CTSA Recruitment and Retention taskforce in 2010 invited representatives at 46 CTSAs to complete an online 48-question survey querying accrual and recruitment outcomes, practices, evaluation methods, policies, and perceived gaps in related knowledge/practice. Descriptive statistical and thematic analyses were conducted.

Results: Forty-six respondents representing 44 CTSAs completed the survey. Recruitment conducted by study teams was the most common practice reported (78%–91%, by study type); 39% reported their institution offered recruitment services to investigators. Respondents valued study feasibility assessment as a successful practice (39%); desired additional resources included feasibility assessments (49%) and participant registries (44%). None reported their institution systematically required justification of feasibility; some indicated relevant information was considered prior to institutional review board (IRB) review (30%) or contract approval (22%). All respondents’ IRBs tracked study progress, but only 10% of respondents could report outcome data for timely accrual. Few reported written policies addressing poor accrual or provided data to support recruitment practice effectiveness.

Conclusions: Many CTSAs lack the necessary frame work to support study accrual. Recom men dations to enhance accrual include articulating institutional expectations and policy for routine recruitment plan ning; providing recruitment expertise to inform feasibility assessment and recruit ment planning; and developing interdepartmental coordination and integrated informatics infrastructure to drive the conduct, evaluation, and improvement of recruitment practices.

Dr. Kost is clinical research officer and director, Regulatory Knowledge and Support Core, Rockefeller University Center for Clinical and Translational Science, New York, New York. She was co-chair of the CTSA Consortium’s Regulatory Knowledge and Support Key Function Committee and Recruitment and Retention Taskforce at the time the work was conducted.

Ms. Mervin-Blake is assistant director for recruitment and special projects, Duke University Clinical Translational Science Institute, Chapel Hill, North Carolina. She was director of operational programs and research recruitment, University of North Carolina Translational and Clinical Sciences Institute, Chapel Hill, North Carolina, at the time the research was conducted.

Ms. Hallarn is program director, Clinical Trials Recruitment Center, Clinical and Translational Science, Ohio State University, Columbus, Ohio.

Mr. Rathmann was director, Recruitment Enhancement Core, Institute of Clinical and Translational Science Regulatory Support Center, Center for Clinical Studies, Washington University School of Medicine in St. Louis, St Louis, Missouri, at the time the research was conducted.

Mr. Kolb is research participant advocate, Clinical and Translational Science Institute, University of Florida, Gainesville, Florida.

Dr. Dennison Himmelfarb is associate professor, Department of Health Systems and Outcomes, Johns Hopkins University School of Nursing, and Division of Health Sciences Informatics, Johns Hopkins University School of Medicine, Baltimore, Maryland.

Ms. D’Agostino is assistant vice president, Sponsored Programs and Pre-Award Management, and assistant director, Clinical and Translational Science Award Regulatory Knowledge and Support Resource, University of Texas Medical Branch at Galveston, Galveston, Texas.

Mr. Rubinstein is executive director for research services, University of Rochester Clinical Translational Science Institute, Rochester, New York.

Dr. Dozier is associate professor, Department of Public Health Sciences, University of Rochester, Rochester, New York.

Dr. Schuff is professor of medicine and co-director, Investigator Support and Integration Services, Oregon Clinical and Translational Research Institute, Oregon Health & Science University, Portland, Oregon. She was co-chair of the CTSA Consortium’s Regulatory Knowledge and Support Key Function Committee at the time the research was conducted.

Funding/Support: This project has been funded in whole or in part with federal funds from the National Center for Research Resources and National Center for Advancing Translational Sciences (NCATS), and National Institutes of Health (NIH), through the Clinical and Translational Science Award (CTSA) Program, including grants numbered UL1TR000043, UL1TR000128, UL1TR000042, UL1TR000083, UL1TR000448, UL1TR000090, UL1TR000424, UL1TR000064, UL1TR000436, and UL1TR000071. The manuscript was approved by the CTSA Consortium publications committee.

Other disclosures: None reported.

Ethical approval: The research project and survey were assessed by the Rockefeller University institutional review board and found to be exempt from review.

Previous presentations: Preliminary and partial data from this work were presented to a limited CTSA audience at the 4th Annual Clinical Research Management Conference; Bethesda, Maryland; June 21, 2011.

Supplemental digital content for this article is available at http://links.lww.com/ACADMED/A208 and http://links.lww.com/ACADMED/A209.

Correspondence should be addressed to Dr. Kost, Rockefeller University, Box 327, 1230 York Ave., New York, NY 10065; e-mail: kostr@rockefeller.edu.

© 2014 by the Association of American Medical Colleges