Journal of Clinical Oncology, Vol 19, Issue 6
(March), 2001: 1728-1733
© 2001 American Society for Clinical Oncology
Prospective Evaluation of Cancer Clinical Trial Accrual Patterns: Identifying Potential Barriers to Enrollment
By Primo N. Lara, Jr,
Roger Higdon,
Nelson Lim,
Karen Kwan,
Michael Tanaka,
Derick H.M. Lau,
Ted Wun,
Jeanna Welborn,
Frederick J. Meyers,
Scott Christensen,
Robert O’Donnell,
Carol Richman,
Sidney A. Scudder,
Joseph Tuscano,
David R. Gandara,
Kit S. Lam
From the Division of Hematology-Oncology, Department of Internal Medicine, and Department of Epidemiology/Biostatistics, University of California Davis Cancer Center, Sacramento, CA
Address reprint requests to Primo N. Lara, Jr, MD, University of California Davis Cancer Center, 4501 X St, Sacramento, CA 95817; email: primo.lara{at}ucdmc.ucdavis.edu
PURPOSE: Well-conducted cancer clinical trials are essential for improving patient outcomes. Unfortunately, only 3% of new cancer patients participate in clinical trials. Barriers to patient accrual in cancer clinical trials must be identified and overcome to increase patient participation.
MATERIALS AND METHODS: We prospectively tracked factors that potentially affected patient accrual into cancer clinical trials at the University of California Davis Cancer Center. Oncologists seeing new outpatients were asked to complete questionnaires regarding patient characteristics and the physician’s decision-making on patient eligibility, protocol availability, and patient opinions on participation. Statistical analysis was performed to correlate these parameters with subsequent protocol accrual.
RESULTS: There were 276 assessable patients. At the initial visits, physicians did not consider clinical trials in 38% (105/276) of patients principally because of a perception of protocol unavailability and poor performance status. Physicians considered 62% (171/276) of patients for participation in clinical trials. Of these, only 53% (91/171) had an appropriate protocol available for site and stage of disease. Seventy-six of 90 patients (84%) with available protocols met eligibility criteria for a particular study. Only 39 of 76 patients (51%) agreed to participate in cancer clinical trials, for an overall accrual rate of 14% (39/276). The remainder (37/76, 49%) declined trial participation despite meeting eligibility criteria. The most common reasons were a desire for other treatment (34%), distance from the cancer center (13%), patient refusal to disclose reason (11%), and insurance denial (8%). Patients with private insurance were less likely to enroll in clinical trials compared to those with government-funded insurance (OR, 0.34; P = .03; 95% CI, 0.13 to 0.9).
CONCLUSION: Barriers to cancer clinical trial accrual can be prospectively identified and addressed in the development and conduct of future studies, which may potentially lead to more robust clinical trials enrollment. Investigation of patient perceptions regarding the clinical trials process and the role of third party–payers is warranted.
Presented in part at the Thirty-Fifth Annual Meeting of the American Society of Clinical Oncology, Atlanta, GA, May 15-18, 1999.
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