Protocol Review and Monitoring System

University Of New Mexico Health Scis Ctr, Albuquerque NM

Investigators

Linked publications & trials

Abstract

The Protocol Review and Monitoring System (PRMS) is an essential component for the conduct of clinical cancer research at the UNM Cancer Center. The PRMS serves to scientifically review and then monitor clinical oncology protocols at the UNM Cancer Center, under the overall supervision of the Clinical Research Committee of the UNM Cancer Center. This Clinical Research Committee serves to supervise and integrate all clinical oncology research efforts at the UNM Cancer Center. The PRMS is made up of two major components, the Protocol Review Committee (directed by Royce) and the Protocol Monitoring Committee (directed by Muller). The Protocol Review Committee (here termed the Medical and Scientific Review Committee) reviews clinical oncology protocols for scientific feasibility and merit. There were 112 protocols submitted for scientific review at the UNM Medical and Scientific Review Committee. Of these 6 were declined by this Committee, and 14 protocols were withdrawn. There were 100 protocols scientifically approved and submitted to Institutional Review Boards for ethical review. In the FY 2008/9, 111 protocols were approved by Institutional Review Boards, and 103 protocols of these were activated for patient accrual. The Protocol Monitoring Committee follows clinical protocols after they are open for accruals, adverse events, and endpoints. This committee has the authority to close protocols if appropriate based on accrual, adverse events, and other rationales. The Protocol Monitoring Committee closed 16 protocols, mainly for poor accrual, while others were closed by the Sponsor or Principle Investigator or by reaching target accruals. In summary, the responsibilities of the PRMS include: 1) Defining and implementing review criteria for all new cancer research protocols, 2) Reviewing the on-going progress of protocols to assure timely and effective performance, 3) Nominating eligible protocols for Protocol-Specific Research Support, and 4) Promoting multi-disciplinary integration of Cancer Center clinical and translational research.