CORE--PROTOCOL REVIEW AND MONITORING SYSTEM

Yeshiva University, New York NY

Investigators

Linked publications, trials & patents

Abstract

DESCRIPTION (provided by applicant): The Protocol Review and Monitoring System (PRMS) is an AECCC shared resource responsible for the scientific oversight of clinical protocol activity. The PRMS has been approved and active since 1995. The three principal components are the Protocol Review Committee (PRC), the Audit Committee, and the Data and Safety Monitoring Committee. The latter two committees report to the PRC which has the ultimate responsibility for protocol review. The PRC is guided by Policies and Procedures established by the AECCC. The role of the PRC is to assess the scientific merit of proposed clinical trials prior to submission to the IRB, to provide resources to assist in the design of clinical trials, and to provide biostatistical and regulatory support for those trials. In addition, the PRC is charged with prioritization of new protocols and with termination of protocols that have met their accrual goals or which are unlikely to meet those goals. Accrual numbers are available through a newly created Microsoft Access-based database, which includes over 600 protocols and over 3000 patients; thus, accruals to every protocol can be accurately tallied on a daily basis. Every cancer-related protocol at AECCC is reviewed by the PRC before submission to the OPRR-approved Institutional Review Boards at the College of Medicine or the Montefiore Medical Center. The twenty members of the PRC include senior clinical investigators representing various oncologic subspecialties, two biostatisticians, regulatory specialists, senior nurses and research pharmacists. From June 1999, to July 2000, the PRC handled 107 new submissions and 705 total submissions. The Audit Committee was recently reformed under the leadership of Dr. Bhadrasain Vikram, Professor and Chairman of the Department of Radiation Oncology, in order to improve the oversight of ongoing clinical trials. The Audit Committee reports to the PRC which recommends either no action, corrective action with a follow-up report, or discontinuation of the study. The policies of the Audit Committee are based on the Eastern Cooperative Oncology Group Audit policies. Monitoring of internal and external adverse events was initially a function of the PRC; in 2000, this function was split out to a separate committee that reports to the PRC. The newly created Data and Safety Monitoring Committee is headed by Dr. Joseph Sparano, Professor of Medicine. Usage of the PRMS will increase in the current year as current programs are expanded and new faculty added, and remains an important resource for clinical investigators from all oncologic subspecialties at AECCC.