Development and validation of a clinical trial feasibility assessment (CTFA) tool and evaluation of the NCI clinical trial evaluation and scoring (NCI-CTES) model.

e16549 Background: The ability to predict accrual success of a specific NCI sponsored clinical trial (CT) in the setting of a Community Clinical Oncology Program (CCOP) is typically based on the experience of the local principal investigator (PI) and research staff. This study was designed to develop an objective method to predict accrual success based on CT and institution specific factors. Funded by ARRA grant #3U10CA35412-26S1. Methods: 27 potential barriers to successful CT accrual were identified by Marshfield Clinic CCOP and validated by Eastern Cooperative Oncology Group (ECOG) PI and research staff (Cronbach alpha 0.922). This 27 item CTFA tool and the NCI-CTES model were prospectively applied to 32 consecutive NCI sponsored CT which opened at Marshfield Clinic CCOP (2009-11). Incorporating PI and research staff input each CT was scored (CTFA range 27-135; NCI-CTES 0-22). These scores were correlated with accrual outcome (Wilcoxon`s rank-sum test). Statistical analysis included CTFA item content v...