Protocol Review & Monitoring Committee

Duke University, Durham NC

Investigators

Linked publications, trials & patents

Abstract

Duke Cancer Institute’s (DCI) Protocol Review and Monitoring System (PRMS) falls within the scope of responsibility of the Protocol Review and Monitoring Committee (PRMC). The PRMC is responsible for implementation of the PRMS function, including evaluating the scientific merit and progress of all studies that meet the DCI definition of “cancer-related”. The PRMC upholds standards in scientific rigor and integrity during the protocol review process, as well as assists investigators and study teams attain such standards by providing essential resources and education, particularly with respect to study design, eligibility, representation in collaboration with the DCI Community Outreach and Engagement program. In 2022, the PRMC established a new training program for oncology fellows and junior faculty to expand the next generation of peer reviewers. By meeting its scientific oversight responsibilities, the PRMC ensures that investigators conduct high quality and impactful clinical research that aligns with the DCI’s research priorities and meets the needs of the DCI patient community. In addition, the PRMC works closely with the clinical/translational Disease Groups and DCI CCSG Research Programs in the prioritization of clinical trials for review. The PRMC is a scientific peer-review committee comprised of 43 voting members that reflect the multidisciplinary clinical and scientific research enterprise at the DCI. The PRMC membership consists of a broad expertise relevant to cancer clinical research and is composed of clinical investigators, investigational pharmacists, biostatisticians, translational MD and/or PhD scientists, and patient advocates. Disease group faculty and staff provide a First Stage review and prioritization of all proposed cancer-related protocols, focused on study merit, feasibility, impact, and applicability to the relevant patient population. Studies approved at First Stage review then undergo a Second Stage scientific review by the PRMC prior to IRB review and study activation. Approved studies that remain open to enrollment must undergo continuing review by the PRMC Accrual Committee. Established accrual requirements are based on study type, if the disease meets the rare cancer definition, and if the study meets the accrual goals for patient representation. PRMC reviews interventional (treatment, preventive, supportive, diagnostic) and non-interventional (ancillary, correlative [tissue-based], observational) studies. In addition, amendments to cancer-related studies are prospectively assessed and reviewed by the PRMC. The PRMC approves well-designed studies that hold the potential to positively affect cancer care and has the authority to terminate studies that fail to demonstrate meaningful progress or lose relevance due to shifting paradigms of cancer research and cancer patient care. During the past project period, PRMC reviewed a total of 1,098 new protocols, 1,504 annual renewals, and 2,803 amendments.