PROTOCOL REVIEW AND MONITORING SYSTEMS

Baylor College Of Medicine, Houston TX

Investigators

Linked publications & trials

Abstract

The Protocol Review and Monitoring Committee (PRMC) provides full scientific review and monitors the progress of and accrual to all cancer clinical protocols Involving patients that are conducted in Dan L Duncan Cancer Center (DLDCC)-affiliated Institutions. PRMC functions are complementary to, but do not overlap those of the Data Safety Monitoring Committee and the IRB. The PRMS reviews all therapeutic and prevention clinical trials whose primary aim Is cancer related. The PRMC Is organized Into an Executive Committee and three working groups, with a total of 45 voting members. The Executive Committee chaired by Dr Stacey Berg the PRMC director assigns each protocol a scientific merit score of 1-9 based on NIH review descriptors as well as DLDCC priority scores of High, Medium, and Low at initial review to aid In prioritization. At the time of each open protocol's annual IRB review, the PRMC Executive Committee conducts a full review to ensure that adequate scientific progress is being made. In addition, the Executive Committee reviews the accrual to all the open protocols in each Program on a quarterly basis. In the 12 month period from July 2008 to June 2009 the PMRC reviewed 50 new protocols including 10 institutional protocols of which 6 were approved pending modification, 3 were tabled, and 1 was disapproved. The PMRC monitored 32 Institutional protocols during this period for performance closing 3 for slow accrual or because new scientific information lowered the priority of the study. The PRMC provides reports to the Clinical Research Leadership Committee which also receives reports from the Data Safety Monitoring Committees ensuring that activities of these two separate entitles are integrated.