PROTOCOL REVIEW AND MONITORING SYSTEM

Emory University, Atlanta GA

Investigators

Linked publications, trials & patents

Abstract

Winship's Protocol Review and Monitoring System (PRMS) requires the review of all proposed cancer clinical trials for scientific quality and merit. The PRMS also calls for the prioritization, monitoring, and termination of protocols based on scientific progress and patient accrual. The Winship Clinical and Translational Review Committee (CTRC) is responsible for these functions. The CTRCs purposes are: 1. To review new proposals for clinical research to ensure that they are scientifically meritorious, that they address significant scientific issues, and that there are sufficient patient and institutional resources to conduct the study as proposed. 2. To prioritize among clinical research proposals within cancer disease sites in order to best fulfill the strategic objectives of the Winship Cancer Institute and of its four research programs. 3. To review the scientific progress of existing clinical research protocols and to terminate protocols in which accrual rates are inconsistent with meeting the stated scientific objective or in which new scientific data renders the trial as having greater safety or efficacy issues or as less scientifically important. 4. To monitor studies for the accuracy and validity of the clinical and laboratory data obtained during the conduct of the clinical study. PRMS is now clearly separated from the Winship Clinical Trials Office (CTO) and the Data Safety and Monitoring Plan (DSMP). In addition, the CTRC has tightened the criteria for new study proposals to achieve scientific review. The changes in criteria include: 1) strict rules regarding the ability of new studies to meet accrual targets, with special attention to any potential eligibility conflict with any ongoing clinical trials, and 2) a requirement that new study proposals address scientific questions relevant to the Winship Cancer Institute's overall scientific goals. The CTRC, under the direction of Thomas Olson, M.D. and Taofeek Owonikoko, Ph.D., M.D expanded to include 24 members and meets on a twice monthly basis to review all proposed cancer clinical trials.