Improved surgeon performance in clinical trials: An analysis of quality assurance audits from the American College of Surgeons Oncology Group

BACKGROUND: The American College of Surgeons Oncology Group (ACOSOG) represents an organized effort by surgeons to participate in clinical trials research. To assess the quality of trial conduct by surgeons on a national level and the feasibility of improvement through education, this study examined the findings of the Quality Assurance Audit Program of the ACOSOG over time. STUDY DESIGN: Outcomes of 249 routine audits conducted from 2001 to 2004 were reviewed for major and minor deficiencies and overall performance (acceptable versus unacceptable) in compliance with regulatory requirements (REG) and patient case review (PCR). RESULTS: From 2001 to 2004, active trials have increased. Major deficiencies in REG fell from 31% to 20% for IRB documentation (p = 0.002) and from 31% to 9% for informed consent (p < 0.001). The major deficiency rates in PCR decreased from 21% to 6% (patient consent), 16% to 7% (eligibility), 13% to 7% (treatment), 34% to 6% (outcomes), 6% to 1% (toxicity), and 16% to 3% (data). During 2001 to 2004, the overall acceptable performance rates were 82%, 72%, 84%, and 92%, respectively, in REG (P = 0.093), and significantly improved in PCR (47%, 55%, 77%, 94%, respectively; p < 0.001). No difference was detected in acceptable rates between academic versus community sites, for either REG (86% versus 76%, respectively; odds ratio: 1.91; 95% CI: 0.87 to 4.19) or PCR (63% versus 68%, respectively; odds ratio: 0.81; 95% CI: 0.42 to 1.53). CONCLUSIONS: Despite initial deficiencies, surgical trials are now conducted with high standards nationwide. In response to educational programs, surgeon performance in clinical trials has measurably improved. Quality assurance audits have served both surveillance and educational roles.