An analysis of corrective action plans to address slow accruing NCI-held IND early phase trials.

6577 Background: In 2011, NCI began requesting Corrective Action Plans (CAP) for early phase trials accruing < 50% of their projected accrual rate after Qtr 2 for Phase 1 (Ph1) or Qtr 3 for Phase 2 (Ph2). Study PIs of low accruing trials are asked to complete and return a CAP within 2 weeks and identify reasons and possible actions to address accrual. We report findings from an analysis of CAPs received on all NCI Cancer Therapy Evaluation Program (CTEP) held IND studies active between Aug 2011 and Feb 2013 (N = 327). Methods: Three methods were employed: 1) content analysis of CAPs to categorize slow accrual reasons and proposed actions (3 coders, intercoder reliability = 78%; 100% after post-coding deliberation); 2) analysis of CAP trial timelines and accrual data; 3) assessment of whether closed CAP trials met their primary scientific objectives. Results: CTEP requested CAPs for 150 (46%) of the 327 trials; 135 were eligible for analysis with 51% Ph1 (n = 69) and 49% Ph2 trials, and 88% adult trials (n...