ense of Urgency: Evaluating the Link between Clinical Trial elopment Time and the Accrual Performance of Cancer

Download pose: Postactivation barriers to oncology clinical trial accruals are well documented; however, pol barriers prior to trial opening are not. We investigate one such barrier: trial development time. erimental Design: National Cancer Institute Cancer Therapy Evaluation Program (CTEP)–sponsored for all therapeutic, nonpediatric phase I, I/II, II, and III studies activated between 2000 and 2004 nvestigated for an 8-year period (n = 419). Successful trials were those achieving 100% of minimum l goal. Time to open a study was the calendar time from initial CTEP submission to trial activation. ariate logistic regression analysis was used to calculate unadjusted and adjusted odds ratios (OR), lling for study phase and size of expected accruals. ults: Among the CTEP-approved oncology trials, 37.9% (n = 221) failed to attain the minimum l goals, with 70.8% (n = 14) of phase III trials resulting in poor accrual. A total of 16,474 patients of accruals) accrued to those studies were unable to achieve the projected minimum accrual goal. requiring less than 12 months of development were significantly more likely to achieve accrual (OR, 2.15; 95% confidence interval, 1.29-3.57, P = 0.003) than trials with the median development of 12 to 18 months. Trials requiring a development time of greater than 24 months were signifiless likely to achieve accrual goals (OR, 0.40; 95% confidence interval, 0.20-0.78; P = 0.011) than with the median development time. clusions: A large percentage of oncology clinical trials do not achieve minimum projected accruals. Con Trial development time appears to be one important predictor of the likelihood of successfully achieving the minimum accrual goals. Clin Cancer Res; 16(22); 5557–63. ©2010 AACR.