Protocol Review and Monitoring System (Core 018)

Ohio State University, Columbus OH

Investigators

Linked publications, trials & patents

Abstract

CORE-018: PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) PROJECT SUMMARY / ABSTRACT The Protocol Review and Monitoring System [PRMS] of the OSUCCC consists of a Clinical Scientific Review Committee [CSRC] that reviews all new cancer-related clinical protocols for scientific merit prior to IRB submission and monitors the scientific progress of ongoing studies including accrual rates. The main CSRC is organized into two teams (with highly similar composition) that collectively meet twice monthly (each once per month), facilitating rapid protocol review. The CSRC consists of 37 members representative of all the OSUCCC research programs and includes clinical and basic researchers, biostatisticians, pharmacists, and research nurses. Additionally, members with specific expertise in the areas of cancer prevention and control as well as pediatrics are convened as CSRC sub-committees to provide focused review of these protocols. At its twice monthly meetings, the main CSRC performs full scientific reviews of all cancer-related clinical protocols initiated by local investigators or pharmaceutical industry sponsors and acknowledges NIH peer-reviewed studies. Each CSRC member is expected to be present at each scheduled meeting, and a majority of the voting members scheduled to be at a meeting must be present to attain a quorum for the meeting. Failure to achieve a quorum at a meeting precludes any business being conducted. In addition to achieving quorum, appropriate reviewer expertise must be present in order for business to be conducted. CSRC approval of a protocol is required prior to its review by the OSU Cancer Institutional Review Board. Each protocol is reviewed by four CSRC members (a primary reviewer, a secondary reviewer, a biostatistician, and a pharmacist). Reviewers follow a written review template that calls for an analysis of the scientific hypothesis and rationale, experimental design, patient inclusion and exclusion criteria, treatment plan, statistical plan, pharmacy considerations and proper prioritization. As of January 2009, all new research protocols undergo concurrent review by the CSRC Logistics Review Committee (LRC), which is a sub-committee of the CSRC. The LRC was implemented to facilitate trial activation and confirm proper research prioritization. The LRC does not evaluate the scientific aspects of the protocol, but does evaluate the availability of the resources necessary to successfully implement and complete the research protocol. The CSRC Executive Committee (EC) provides oversight to the CSRC. It is led by the CSRC Chair. The EC consists of eight CSRC members that meet monthly to review protocol accrual and scientific progress and ensure that protocol prioritization rules are followed. The CSRC EC is responsible for communication with investigators whose clincial trials are not meeting their accrual goals and providing support to facilitate accrual. The CSRC adheres to a set of well- defined criteria for accrual monitoring and trial prioritization. Those ongoing studies that do not show adequate accrual or fail to meet accepted standards of quality control based on formal audits are terminated. In 2014, the CSRC closed 18 trials for low accrual. The EC also performs expedited reviews for appropriate studies (e.g., retrospective studies). In the last year (12/1/13 to 11/30/14), 199 new protocols were reviewed by the CSRC with the following dispositions: 68 (34%) were approved as written, 55 (28%) were approved with stipulations, 14 (7%) were deferred, 57 (29%) were administratively acknowledged after having undergone previous NIH peer-review, and 5 (2%) were disapproved. Twenty-eight non-interventional protocols were also administratively approved by the CSRC EC.