The Protocol Review and Monitoring System (PRMS) ensures adequate internal oversight of the scientific aspects of all cancer clinical trials conducted at the Stephenson Cancer Center. PRMS review focuses on scientific merit, study prioritization, data integrity, scientific relevancy, inclusion of underrepresented populations, and accrual progress.
Review and monitoring of new and ongoing clinical trial protocols occurs in two stages:
Stage One: Disease Groups comprised of physicians, nurses, pharmacists and investigators representing specific disease-site cancers (e.g., breast, urologic, lung, etc.) review all new clinical trial protocols to assess scientific merit, applicability to current and underrepresented patient populations, overlap with potentially competing trials, and whether the protocol aligns with Disease Group goals. Disease Groups also conduct continuing review of open protocols in their area, focusing on accrual progress, new safety information, and continuing scientific relevancy, to help ensure timely completion of the study.
Stage Two: The Protocol Review and Monitoring Committee (PRMC) – which is comprised of faculty representing basic laboratory, clinical, behavioral, biostatistical, and population science – conducts an independent review of all new protocols to evaluate scientific merit, statistical validity, design feasibility, inclusion of underrepresented populations, and study prioritization. The PRMC will refer protocols that need further development back to the appropriate Disease Group, along with recommendations for enhancing protocol design. All new clinical trial protocols must have PRMC approval before proceeding to the Institutional Review Board (IRB). In addition, the PRMC is responsible for conducting continuing review of open protocols, focusing on accrual progress, new safety information, and continuing scientific relevancy, to help ensure timely completion of the study. The cancer center director has delegated to the PRMC the sole authority to authorize activation and termination of clinical trials at the Stephenson.