NCI pilot intervention program to assist accrual for challenging late-phase clinical trials.

6617 Background: Since 2010, the National Cancer Institute (NCI) has taken substantial efforts to compress the timelines for protocol review and trial activation (Abrams, JNCI, 2013). In 2012, NCI’s Cancer Therapy Evaluation Program (CTEP) began a pilot in collaboration with NCI Cooperative Groups (CG) to support accrual to Phase 2-3 treatment trials identified as potentially challenging or at risk for insufficient accrual (Korn, JCO, 2010). Pilot program findings are reported. Methods: CG trials were identified for the pilot if accrual concerns were raised during the concept or protocol review or were at risk of not meeting CTEP’s slow accrual guidelines after activation. In collaboration with CG study teams, each trial underwent the following evaluation and analyses: accrual feasibility/challenges; site activation data; tailored interventions to address challenges, track and report accrual changes. Results: To date, 18 trials are in the pilot (10 identified pre-activation, 8 post-activation). Nine recei...