Organizational barriers to physician participation in cancer clinical trials.

OBJECTIVE: To assess barriers to physician participation in cancer clinical trials among oncologists, oncology leaders, and health plan leaders. STUDY
DESIGN: Mail survey of 221 oncologists combined with semistructured telephone interviews with oncology and plan leaders at 10 integrated healthcare systems.
METHODS: The survey instrument examined physicians' involvement in clinical trials; their perception of the value of trials to them, their patients, and their organization; and the presence of infrastructure support for trials and associated resource constraints. The interviews investigated similar issues from the leaders' perspective. We used linear regression to model trial enrollment and standard qualitative techniques to analyze the interviews.
RESULTS: Oncologists estimated they enrolled 7% of patients in trials. They expressed extremely favorable attitudes toward trials as a source of high-quality patient care and a benefit to themselves professionally. While positive attitudes toward trials were common, and were significant bivariate predictors of enrollment, organizational factors were the predominant predictors in multivariate analysis. The best combination of factors independently predicting enrollment related to organizational support for trials, subspecialty of the oncologist, and limitations of trial eligibility requirements.
CONCLUSIONS: To increase trial participation, there is a critical need for infrastructure to support trials, especially additional support staff and research nurses. In addition, there is a need for better intra-organizational communication and consideration of the impact of trial design on internal health plan resources. This research supports the need to continue a national dialogue about the broadly defined benefits and costs of clinical trials to patients, physicians, and health plans.