RTOG physician and research associate attitudes, beliefs and practices regarding clinical trials: implications for improving patient recruitment

Abstract

Purpose: Timely recruitment and retention of human subjects remains a leading problem in oncology clinical trials even among the national oncology clinical trial cooperative groups. The Radiation Therapy Oncology Group (RTOG) developed an exploratory survey to assess member attitudes, beliefs, and practices (ABPs) towards clinical trials that might influence patient accrual to clinical trials.

Methods: The survey was developed using Survey Monkey(c) and emailed to principal investigators (PIs) and research associates (RAs) at 267 RTOG member institutions. Survey items were selected based on a review of the literature. PI and RA responses were matched by institution to determine whether responses varied due to job responsibilities and/or institutional practices. Principal component analysis was used to achieve variable reduction in further describing respondents' ABPs.

Results: PIs and RAs reported similar recruitment concerns [kappa=0.55, 95% CI (0.51, 0.60)]. Five components related to recruitment concerns were identified: presentation of trials to patients, barriers and recruitment risks, staff involvement, access for underrepresented populations, and familial involvement (patient). Nearly one of four (24%) respondents perceived that patients did not understand what randomization means. Staff issues included nearly a third of respondents not having a formal mechanism at their institution for eligibility screening, and similarly, about one of three respondents felt that unrepresented patient populations would benefit from translated consent forms.

Conclusions: Findings of this survey inform RTOG strategies for addressing opportunities for improvement, including clinician/patient education and a best practices tool box that in the future would include successful mechanisms for eligibility screening and recruitment.