The goal of the Protocol Review and Monitoring System (PRMS) is to promote the conduct of scientifically meritorious clinical research under the aegis of the UCSD Moores (iancer Center. The mechanism for accomplishing this goal is the establishment of a Protocol Review and Monitoring Committee (PRMC) to provide internal oversight of all clinical and translational research involving subjects with cancer. The PRMC has the following Specific Objectives: (1) perform scientific peer review of cancer-related clinical and translational research protocols to be conducted at UCSD, at affiliate institutions Rady Children's Hospital San Diego (RCHSD) and the Veterans Affairs San Diego Healthcare System (VASDHS), and to be conducted by consortium partner San Diego State University (SDSU);(2) approve a priority designation for new interventional cancer clinical protocols in coordination with leaders of the Cancer Center's multidisciplinary Disease Teams;and (3) review the scientific progress of active interventional protocols through annual evaluation of subject accrual data. The PRMC is granted authority by the Cancer Center Director to approve, defer, or disapprove the activation of research protocols that involve patients with cancer, biological specimens from cancer patients, or subjects that are at significant risk to develop cancer during the study period. The PRMC can issue binding recommendations for protocol modification or amendment for reasons of scientific validity or subject safety and issue recommendations to the Director of the Clinical Trials Office (CTO) for closure of protocols with unsatisfactory accrual or for changes in scientific knowledge. In concert with these scientific review and monitoring functions, the PRMC directly informs the Institutional Review Boards of relevant scientific and participant safety issues for complementary review of cancer-related research protocols. PRMC membership is composed of clinical and basic scientists as well as biostatisticians with expertise to perform unbiased evaluations of cancer protocols submitted for PRMC review and monitoring. In achieving its scientific review and monitoring objectives, the PRMC ensures that Cancer Center resources are effectively utilized to foster clinical cancer research that is of high scientific quality and importance.
The specialized clinical, scientific, and pharmacy expertise of the Protocol Review and Monitoring Committee is brought to bear in evaluating the supporting data and rationale for investigational cancer therapies and the adequacy of monitoring for toxicities. Review of scientific validity, value, and feasibility promote the Cancer Center's mission to develop novel therapies and provide access to leading-edge care for patients with cancer.
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