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Toward a Comprehensive and Accurate Measure of Clinical Trial Workload, Equity, Quality Assurance and Patient Safety-How Much Workload is Too Much? Commentary and Brief Research Report

Ralph Jay Johnson

This article provides a brief commentary on the methodology surrounding controlled clinical trials, the growing trend of centers conducting multiple controlled trials (i.e. “factory science”), trial workload measures, and possible relationships among workload, especially excessive workload, and mistakes, mishaps, deviations, violations, or just plain slippage. Findings are reported for each factor or measure included in an incremental algorithm designed to provide a numeric score for clinical trial workload. This algorithm was developed in the interest of quality assurance as part of program evaluation through an Oracle Delphi process by a study group of subject matter experts who work with a substantial number of clinical trials in an international cancer center in Houston, Texas (UT-MD Anderson). At a minimum, the algorithm also reflects the complexity of the issues surrounding the clinical trial workload and the conduct of clinical trials in general. Unlike previous measures reported in the literature, it may lack in simplicity for expedient use as a tool for informing management, although it provides comprehensiveness and accuracy and lends itself more to scientific testing. Future avenues of study are considered.