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

Abstract

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 validity testing via item-test correlation and CTFA/NCI-CTES internal consistency reliability testing via Cronbach alpha. Results: 28/32 CT were available for analysis; 4 CT were excluded (never opened to accrual). Duration of time open to accrual ranged from 1-27 months (mean=13.5). 21/28 CT achieved accrual ranging from 1-50 subjects (1-5 accrual=13; 5-10=4; >10=4). Median time to complete the 27 item CTFA tool was 16 minutes and 8 minutes for the NCI-CTES model. After eliminating 6/27 CTFA items due to low content validity (<0.2), the remaining 21 item final CTFA tool indicated very high internal consistency reliability (Cronbach alpha 0.872). Wilcoxon`s rank-sum test revealed that the differences in NCI-CTES and CTFA scores between the groups with <=0.25 and >0.25 subject accrual per month were significant (CTFA P-value=0.0418; NCI-CTES P-value=0.0032). Conclusions: Application of the CTFA tool and the NCI-CTES model proved to be feasible and predictive of accrual success of NCI sponsored clinical trials at Marshfield Clinic CCOP.