Core--Protocol Review and Monitoring System

Wayne State University, Detroit MI

Investigators

Linked publications, trials & patents

Abstract

The Protocol Review and Monitoring System (PRMS) was first implemented in the early 1990s to oversee scientific cancer research involving cancer patients in the facilities of the institutions that define the Karmanos Cancer Institute. The main objectives of the monitoring system include the following: 1) review the scientific merit of cancer research protocols; 2) ensure prioritization of therapeutic cancer protocols according to KCIs scientific priorities; 3) monitor scientific progress. The committee is composed of a complementary mix of senior and junior investigators from various disciplines, and specialities, as well as representatives from the Biostatistical Core, nursing and physician extenders, and administrative support staff from the CTO. The members of the committee represent a sufficient size, and breadth of expertise to conduct a critical, fair scientific review of all clinical research protocols involving cancer patients in the institutions comprising the Cancer Center. The PRMS provides internal oversight of the scientific and research aspects of the cancer trials, in addition to assuring that its clinical resources are engaged to ensure the best practices for scientific endeavors and applications. The function of the PRMS is complementary to that of the Institutional Review Board, which focuses on the protection of human subjects. The PRMS is not intended to duplicate or overlap the responsibilities of the IRB, nor is it intended to perform an auditing or data and safety monitoring function. The PRMS evaluates all cancer clinical trials, whether derived and supported from institutional sources or from industry. However, the PRMS does not duplicate the results of traditional peer review, which includes protocols supported by various NIH mechanisms (e.g., R01s, U01s, P01s, U10s and P50s), and clinical research protocols approved by the NCI's Cancer Therapy Evaluation Program. Scientific review takes into account the specific rationale, study design, duplication of studies already in progress elsewhere, adequacy of biostatistical input, and feasibility for completion of the study within a reasonable time frame.