CORE--PROTOCOL REVIEW AND MONITORING SYSTEM

University Of Texas Md Anderson Can Ctr, Houston TX

Investigators

Linked publications, trials & patents

Abstract

The Protocol Review and Monitoring System (PRMS) continues to have as its major goal the assurance of the quality of the clinicaL research at the M.D. Anderson Cancer Center. PRMS consists of three major elements. Fist, the Clinical Research Committee and Psychosocial, Behavioral and Health Services Research Committee review the scientific aspects of protocols. This review includes the determination of validity of the scientific question, the appropriateness of the design of the study, the applicability of the proposed biostatistical methods of analysis, and the feasibility of the study reaching its state objectives. Second, the Protocol Data Management System (PDMS) must be used to register all patients of clinical trials. An eligibility checklist must be successfully completed prior to patient registration and release of drug from the pharmacy. Thus, a single database now exists in which clinical trials patient information is deposited for review and audit. Third, the Office of Clinical Research Quality Assurance audits the performance of the trial with the approved protocol and the agreement of the PDMS database with the patient record (two random audits per month). Thus, critical elements of the Clinical Trials Support Resource Core constitute the various checkpoints for PRMS process. Protocol prioritization remains the responsibility of the clinical departments. This is because the major expertise for prioritization of disease-specific protocols resides in these departments. However, the committees reviewing the scientific of proposals can disapprove or make approval contingent upon appropriate prioritization of protocols at any time during the review process. Further, the Office of Clinical Research Quality Assurance has received investigators' requests to close over 100 protocols following a detailed review of accrual done by that office. This is a regular, on-going activity of this office (every 6 months). Using this three-part system, we have developed a PRMS that assures the highest standards of peer-reviewed clinical research, a system of random audits, and an institution-wide database that allows auditing and data monitoring functions to occur rapidly and with minimal disruption to on- going work.