Improving the efficiency and effectiveness of clinical research regulatory review processes: Lessons from the Six Sigma Body of Knowledge

Abstract

e17554 Background: The duration and complexity of regulatory review processes are increasingly associated with the slow pace and high cost of clinical trials. To evaluate and minimize the impact of these factors, City of Hope (COH), a NCI-designated Comprehensive Cancer Center, developed a strategic initiative to improve the efficiency and effectiveness of its clinical research review processes. The ongoing initiative is supported by Six Sigma-based techniques for problem identification and process optimization that have been successfully applied in other industries. Methods: The Six Sigma process improvement methodology known as DMAIC (Define, Measure, Analyze, Improve, and Control) was applied to five different clinical trial submission types (new study submissions, amendments, continuations, internal adverse events, external adverse events) reviewed by the COH Institutional Review Board (IRB), Cancer Protocol Review and Monitoring Committee (CPRMC), and Data and Safety Monitoring Board (DSMB). A consistent set of metrics and expectations were created for each review process to evaluate pre-review queue times, review process durations, submissions returned for corrections, and submissions returned with conditional approvals. Results: Over 7,900 submissions received during a 15 month period were evaluated quarterly to identify opportunities for improvement and the effects of previously implemented solutions. Multiple root causes for submission defects and delays were identified, including: (1) staffing and training deficiencies, (2) suboptimal workload distribution, (3) unclear policies and processes, (4) submission standardization opportunities, and (5) workflow automation and other information technology opportunities. Ongoing remediation efforts have yielded substantial improvements. Conclusions: Although Six Sigma process improvement techniques were originally developed for manufacturing applications, they can be applied in a clinical research setting to improve regulatory review processes. The methodology was most effectively introduced incrementally via application to specific problems rather than a traditional top-down implementation. Support provided by NCI P30 CA33572. No significant financial relationships to disclose.