PROTOCOL REVIEW AND MONITORING SYSTEM

Case Western Reserve University, Cleveland OH

Investigators

Linked publications, trials & patents

Abstract

The Protocol Review and Monitoring Committee (PRMC) was established in 1991 at UHC. In July 2004, a joint PRMC comprised of 49 members (31 from Case/UHC; 16 from CCF/CCLCM; and 2 patient advocates) from the partner institutions of the Case Comprehensive Cancer Center was implemented, in which all cancer protocols are reviewed in partnership for scientific merit and prioritization. The PRMC serves as the focal point for the assessment of all new therapeutic clinical trials at the Case Comprehensive Cancer Center by providing protocol review (and associated feedback to assist protocol development), and scientific monitoring. The Committee considers new concepts [letters of intent (LOIs)] submitted by individual investigators, reviews new protocols and amendments, receives adverse events and clinical responses, and monitors the scientific progress of active studies. While the emphasis is on the development, review, and approval of investigator-initiated clinical trials and protocol concepts, all therapeutic trials are reviewed by this committee including NCI-sponsored (e.g., R21, R01 and U01/N01), cooperative group (e.g., ECOG, SWOG, RTOG, NSABP, GOG and others), pharmaceutical, and multi-institutional consortium studies. The PRMC also reviews behavioral and observational trials on cancer patients. Institutional commitment to this charge is indicated by a directive from both UHC and CCF Chiefs of Staff, that all clinical trials for patients with cancer be reviewed by this Committee prior to review by the Case Cancer IRB. The PRMC does not engage in primary safety monitoring or auditing of data. However, it does receive data safety and toxicity reports, clinical response reports, and quality assurance reports generated by: (1) the Clinical Trials Unit (CTU) audit systems and other audit reports (e.g., NCI, cooperative group, pharmaceutical sponsor); (2) the Patient Protocol Review Committees for Phase I trials (Dr. Dowlati, Chair), and the stem cell therapies and acute leukemia trials (Dr. Laughlin, Chair); and (3) the Cancer Center Data Safety and Toxicity Committee (DSTC, Dr. B. Cooper, Chair). The Committee also closely interacts with Clinical Trials Disease Teams, where initial pre-review for all therapeutic trials is undertaken. The teams provide pre-review by experts in their field for scientific merit, prioritization, and intent to accrue patients. Interactive Clinical Trials Disease Teams with respective co-leaders at each partner institution were established by the Cancer Center for directing the clinical trials research agenda for each team. The co-leaders are charged with setting a single research agenda, identifying new studies for activation, and making recommendations to the PRMC. The senior leadership identified this as an important strategy to build advocacy for any given trial at the physician-investigator level and to charge the teams with driving their respective trials agenda in order to grow the partnership. This strategy was fully endorsed by our external advisors. The Committee is comprised of clinical investigators in all cancer modalities, laboratory scientists, biostatisticians, and patient advocates. CCSG support for a total of 1.10 FTE is requested for the Chair (Dr. Sagar, 0.025 FTE), the 3 co-chairs (Drs. Budd, Lazarus and Waggoner, each at 0.025 FTE), and the Administrative Director (Ms. Naser, 1.0 FTE). Recommendations for scientific merit and priority for accrual are directly communicated to the Case Cancer IRB