Protocol Review and Monitoring System

PROJECT SUMMARY/ABSTRACT – PROTOCOL REVIEW AND MONITORING SYSTEM The PRMS at FCCC involves a two-stage review process. The first stage is done by the disease site team (DST) and the Office of Clinical Research Feasibility Committee (OCF). DSTs assess studies using two levels of criteria. They will decline protocols if there is lack of resources (e.g. patient population, clinical research personnel), or competing trials (1st level criteria). We have enhanced the process for first stage review by development of a redcap form for capturing declined studies. Protocols found to be of interest are formally reviewed at disease group meetings that occur at least monthly, assessing scientific interest, significance to patient population and catchment area (2nd level criteria). The DSTs are using a new uniform tool to assess treatment studies that considers data on annual accrual potential, potential to accrue minority and underrepresented patients, competing studies, source of the trial (i.e. IST/NCTN versus industry) and consideration of the phase/potential impact of the study question; these data are calculated to give the PRMS score, a percent of the highest possible score with studies rated as Good (<50%), Excellent (51-75%) or Outstanding (>75%). Once proposed for the second stage review, the OCF evaluates protocols to determine if trials are able to be conducted. Upon approval by OCF, studies enter Second Stage review done by the Research Review Committee (RRC) which evaluates and provides scientific prioritization of all interventional trials at FCCC, with careful deliberation on investigator initiated studies. The RRC is comprised of physicians from all disciplines, translational researchers, pharmacists, biostatisticians, as well as researchers from nursing and the Cancer Prevention and Control Program. We have enhanced the review regarding relevance to the catchment area by adding a new review criterion; we also have developed a training program for community members to serve as RRC reviewers with the first cohort to begin in Q1 2024. All new protocols that contain human research at FCCC are reviewed prior to submission to the Cancer Center's Institutional Review Board. The PRMS also includes the RRC Protocol Accrual Monitoring subcommittee (PAMS), which is responsible for monitoring the progress of studies to ensure that the use of ongoing OCR resources in support of studies is justified. The subcommittee meets bi-weekly to review accruals and communicate with investigators when protocols are at risk for termination due to poor accrual or recommended for closure due to low accrual. We have enhanced our oversight by assessing new studies at 6 months; those with no accrual are given a 6-month warning letter.