Factors influencing enrollment in clinical trials for cancer treatment.

Abstract

Recruitment of cancer patients to clinical trials is an ongoing challenge. In this study, we assess factors that may influence enrollment in clinical trials for cancer treatment. Between June 1997 and January 1998, data were collected on all adult cancer patients evaluated for enrollment in National Cancer Institute-sponsored clinical trials at 15 medical facilities in the southeastern United States. More than 2,300 cancer patients were evaluated; 7% were enrolled. Neither patient sex nor race predicted enrollment. Patients with fee-for-service coverage were more than twice as likely to be enrolled compared with patients with other types of coverage, including managed care. Patient refusal accounted for the nonenrollment of nearly 40% of those clinically eligible. Although multiple factors influence enrollment in clinical trials for cancer treatment, results suggest that insurance coverage plays a role. Patient refusal, a substantial reason for nonenrollment, points to the need for continued efforts to educate physicians and the public in the value of clinical trials.