The National Cancer Institute–American Society of Clinical Oncology Cancer Trial Accrual Symposium: Summary and Recommendations

Copyright © 2013 by American Society of Clinical Oncology

The National Cancer Institute–American Society of Clinical Oncology Cancer Trial Accrual Symposium: Summary and Recommendations

1. Andrea M. Denicoff, MS, RN⇑,
2. Worta McCaskill-Stevens, MD, MS,
3. Stephen S. Grubbs, MD,
4. Suanna S. Bruinooge,
5. Robert L. Comis, MD,
6. Peggy Devine,
7. David M. Dilts, PhD, MBA, CMA,
8. Michelle E. Duff, DPT,
9. Jean G. Ford, MD,
10. Steven Joffe, MD, MPH,
11. Lidia Schapira, MD,
12. Kevin P. Weinfurt, PhD,
13. Margo Michaels, MPH,
14. Derek Raghavan, MD, PhD,
15. Ellen S. Richmond, MS, RN,
16. Robin Zon, MD, FACP, FASCO,
17. Terrance L. Albrecht, PhD,
18. Michael A. Bookman, MD,
19. Afshin Dowlati, MD,
20. Rebecca A. Enos, RN, MPH,
21. Mona N. Fouad, MD, MPH,
22. Marjorie Good, RN, MPH, OCN,
23. William J. Hicks, MD,
24. Patrick J. Loehrer Sr, MD,
25. Alan P. Lyss, MD,
26. Steven N. Wolff, MD,
27. Debra M. Wujcik, PhD, RN, FAAN and
28. Neal J. Meropol, MD

+ Author Affiliations

1. National Cancer Institute; Education Network to Advance Cancer Clinical Trials, Bethesda; The EMMES Corporation, Rockville, MD; Delaware Cancer Consortium, Dover; Helen F. Graham Cancer Center, Newark, DE; American Society of Clinical Oncology, Alexandria, VA; Coalition of Cancer Cooperative Groups; University of Pennsylvania Perelman School of Medicine, Philadelphia, PA; Cancer Information & Support Network, Auburn, CA; Oregon Health & Science University, Portland, OR; Pancreatic Cancer Action Network; Brooklyn Hospital Center, New York, NY; Massachusetts General Hospital, Boston, MA; Duke Clinical Research Institute, Durham; Levine Cancer Institute, Carolinas HealthCare System, Charlotte, NC; Michiana Hematology Oncology and Northern Indiana Cancer Research Consortium, South Bend, IN; Barbara Ann Karmanos Cancer Institute, Detroit, MI; University of Arizona Cancer Center, Tucson, AZ; Case Comprehensive Cancer Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland; The Ohio State University, Columbus, OH; University of Alabama at Birmingham, Birmingham, AL; Indiana University Simon Cancer Center, Indianapolis, IN; Heartland Cancer Research CCOP, St. Louis, MO; Meharry Medical College; and Vanderbilt-Ingram Cancer Center, Nashville, TN

1. Corresponding author: Andrea M. Denicoff, MS, RN, National Cancer Institute, Cancer Therapy Evaluation Program, Clinical Investigations Branch, 9609 Medical Center Dr, MSC 9737, Bethesda, MD 20892-9737; e-mail: Denicofa@mail.nih.gov.

Abstract

Introduction: Many challenges to clinical trial accrual exist, resulting in studies with inadequate enrollment and potentially delaying answers to important scientific and clinical questions.

Methods: The National Cancer Institute (NCI) and the ASCO (ASCO) cosponsored the Cancer Trial Accrual Symposium: Science and Solutions on April 29-30, 2010 to examine the state of accrual science related to patient/community, physician/provider, and site/organizational influences, and identify new interventions to facilitate clinical trial enrollment. The symposium featured breakout sessions, plenary sessions, and a poster session including 100 abstracts. Among the 358 attendees were clinical investigators, researchers of accrual strategies, research administrators, nurses, research coordinators, patient advocates, and educators. A bibliography of the accrual literature in these three major areas was provided to participants in advance of the meeting. After the symposium, the literature in these areas was revisited to determine if the symposium recommendations remained relevant within the context of the current literature.

Results: Few rigorously conducted studies have tested interventions to address challenges to clinical trials accrual. Attendees developed recommendations for improving accrual and identified priority areas for future accrual research at the patient/community, physician/provider, and site/organizational levels. Current literature continues to support the symposium recommendations.

Conclusions: A combination of approaches addressing both the multifactorial nature of accrual challenges and the characteristics of the target population may be needed to improve accrual to cancer clinical trials. Recommendations for best practices and for future research developed from the symposium are provided.