Protocol Review and Monitoring System

ABSTRACT: Protocol Review and Monitoring System (PRMS) The overall goals of the Protocol Review and Monitoring System (PRMS) are to ensure that all MD Anderson human subjects research is of the highest scientific merit and that all approved and/or activated clinical trials are completed in a timely manner. The PRMS is supported by 35 staff members (of whom 3 receive a portion of support from the CCSG) under the direction of Dr. Aman Buzdar, associate director for clinical research administration. Dr. Buzdar oversees all aspects of the PRMS at MD Anderson and reports directly to the associate director for clinical and interdisciplinary research, Dr. George Wilding. The PRMS ensures adequate internal oversight of the scientific and research aspects of institutional clinical trials through a rigorous review of the scientific merit, progress, and priorities of the clinical research protocols conducted by cancer center members. The PRMS consists of four Scientific Review Committees (SRC 1–4) and one Psychosocial and Behavioral Health Services Research Committee (PBHSRC) that review protocols for scientific merit and prioritization. In FY2017, a total of 437 new protocols were submitted to the PRMS (SRC/PBHSRC) peer review process, and 382 protocols were reviewed in SRC/PBHSRC meetings, including 342 new interventional protocols. The chairs of these committees are also members of the Electronic Protocol Accrual Auditing Committee (ePAAC) that selects and monitors all institutional protocols identified as underperforming (e.g., no or slow accrual, delayed activations). The ePAAC meets every 6 months and reviews selected protocols, including active protocols previously reviewed but requiring a follow-up review at 6 months. A total of 500 protocol reviews were completed in the last fiscal year (FY2017). An ePAAC subcommittee consisting of institutional leadership was recently formed to enhance the quality of the ePAAC review process. This subcommittee meets prior to each convened ePAAC meeting to critically review low-performing interventional trials that are open for enrollment but have demonstrated consistent challenges in meeting accrual goals post- activation (e.g., > 3 consecutive ePAAC reviews) as well as trials that are IRB-approved but have not been activated for 6 months or longer. New initiatives include allowing disease-specific programs to select disease- specific content experts to conduct the mandatory medical review of SRC-submitted protocols to enhance content expertise; documenting types and outcomes (approval/rejection and prioritization) of “local” disease- specific protocol reviews; and streamlining protocol activation timelines. In addition, the Office of Clinical Research Administration underwent a substantive evaluation of all departments and functions in the spring of 2018, resulting in a revised organizational structure and greater emphasis on integration and accountability across departments to enhance efficiencies within related processes and ensure ongoing performance improvements.