Protocol Review and Monitoring System

Emory University, Atlanta GA

Investigators

Linked publications, trials & patents

Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM PROJECT SUMMARY/ ABSTRACT The Protocol Review and Monitoring System (PRMS), administered by Winship?s Clinical and Translational Review Committee (CTRC), is responsible for the review and approval of all cancer clinical trials proposed by Winship members for scientific quality and merit. The CTRC is charged with the responsibility to prioritize, monitor, and terminate clinical trials based on ongoing scientific validity, feasibility, overall progress, and patient accrual. CTRC?s overarching goal is to support and facilitate the conduct of Winship?s clinical cancer research efforts. To fulfil this goal, CTRC addresses the following set of objectives using clearly-defined criteria and mechanisms to: (1) review new clinical research proposals for scientific rationale, appropriate design, and feasibility; (2) prioritize clinical research proposals using uniform and objective metrics in consultation with Winship?s cancer disease-site working groups and with Winship?s research programs to ensure alignment with Winship?s overall strategic objectives; (3) review and monitor the progress of active clinical studies for accrual and scientific validity, and to terminate protocols which are not meeting accrual targets and/or where new scientific evidence renders the study irrelevant; (4) determine and assign level of potential risk to patients enrolled on study that will inform the rigor and frequency of review by Winship?s Data Safety Monitoring Committee (DSMC); and (5) provide a platform for educating the next generation of clinical researchers on the best practices in the design and conduct of cancer clinical trials. The CTRC functions as a distinct, independent body from the Winship Clinical Trials Office (CTO) and the DSMC. Significant changes instituted to enhance the function of the CTRC in response to suggestions emanating from the last CCSG competitive renewal include: (1) enactment of review guidelines to assess the ability of new studies to meet accrual targets, with special attention to potential eligibility conflict with ongoing clinical trials; (2) adding a requirement that new study proposals address scientific questions relevant to Winship?s overall mission and objectives of its research programs; (3) adding a requirement for institutional (investigator-initiated) proposals to undergo biostatistics review prior to submission for CTRC review and to include a co-investigator from Winship?s Biostatistics and Bioinformatics Shared Resource (BBISR); (4) requiring a risk level determination at the time of scientific review for all treatment trials; (5) instituting a regular biennial survey of Winship members to obtain feedback on CTRC function and value added to Winship?s clinical research activities; and (6) recognizing outstanding CTRC members (excluding co-chairs) based on specific metrics including meeting attendance and protocol review.