Barriers and facilitators to enrollment in cancer clinical trials: qualitative study of the perspectives of clinical research associates.

BACKGROUND: The literature continues to report low rates of accrual to cancer clinical trials. Previous studies have examined principally physician-related or patient-related barriers. Clinical research associates (CRAs) have a unique perspective on enrollment that has been explored very little. This study sought the views of CRAs on barriers and facilitators to accrual. METHODS: Focus groups were held at six of eight tertiary cancer centers in Ontario, Canada. Audiotapes of sessions were transcribed and subjected to content analysis by two of the authors. Emergent themes were identified. These themes are illustrated by representative quotes taken from the transcripts. RESULTS: Factors that acted as barriers or facilitators were classified into physician-related, patient-related, or system-related factors. CRAs identified physician attitudes regarding patient participation as the principal physician-related barrier. Barriers, facilitators, and modifying factors that were related to patient involvement were discussed by CRAs. Patients seemed more knowledgeable about trials than in the past and were willing to participate. System factors were considered to have the greatest impact on the ability to accrue. CRAs identified increasing trial and pharmaceutical demands coupled with tight trial time lines. Time was seen as a diminishing resource. Greater demands not only affect specific clinical trial accrual but also affect general support for trials in the cancer center and hospital. CONCLUSIONS: The impact of greater demands in a climate of decreasing health care resources is perceived by CRAs as having a negative affect on accrual. Consequently, the important process of translating potentially beneficial basic research findings into clinical practice is slowed.