6557 Background: Observations at the authors’ institutions and by Dilts et al (JCO 2008, abstr 6534) indicate a high percentage of industry (IND)- and cooperative group (CG)-sponsored therapeutic clinical trials (TCTs) with minimal enrollment. We observed most of the enrollment from a small proportion of the TCTs. To determine if this data was representative of other cancer centers (CCs) we examined accrual to IND- and CG-sponsored adult TCTs from 14 CCs. Methods: Accrual data to IND- and CG-sponsored TCTs was obtained from 14 U.S. CCs. Data for the 3-year period from 2005 through 2007 was analyzed. Pediatric TCTs were excluded. Results: Of 2,685 TCTs, 1455 (54.2%) did not accrue any patients (pts). Only 713 (26.6%) TCTs enrolled > 2 pts and these TCTs provided 88.8% of the total enrollment. Resource utilization: We estimate > 230,000 hours (median: 3,773 hours per CC per year) were devoted to study start up and regulatory maintenance for the 1,455 TCTs that did not accrue any pts (Guidance Document for Implementing Effective Cancer Clinical Trials, www.c-changetogether.org/pubs/default.asp). Conclusions: Approximately 90% of the accrual to IND and CG TCTs is from 26% of these TCTs. Significant resources are used on TCTs that do not contribute significantly to overall accrual. Effective rules governing selection of IND and CG TCTs for activation are needed. Effective rules will enable centers to re-direct valuable resources to useful activities without adverse effect on overall enrollment. [Table: see text] No significant financial relationships to disclose.
A Bayesian seamless phase I–II trial design with two stages for cancer clinical trials with drug combinations