Protocol Review and Monitoring System

Mayo Clinic Rochester, Rochester MN

Investigators

Linked publications, trials & patents

Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM PROJECT SUMMARY The Mayo Clinic Cancer Center (MCCC) provides oversight for the scientific aspects and performance of cancer interventional clinical trials conducted at Mayo Clinic through the Center's Protocol Review and Monitoring System (PRMS). The focus of the PRMS is on scientific merit, priorities, and progress of the clinical research protocols conducted at the MCCC. The Scientific Review Committee (SRC) uses a consistent and defined process for scientific review that is achieved through established written review criteria, common reporting forms, and defined expectations. The SRC has responsibility for the approval and/or disapproval of each study, as well as for the final decision concerning prioritization. To accommodate the increasing complexity and volume of trials, 4 SRC subcommittees cover trials in hematology and solid tumors with drug- predominant therapy, radiation-predominant therapy, and surgery-predominant therapy, respectively. Another subcommittee of the SRC, the Scientific Progress Review Subcommittee (SPRC), reviews modifications and amendments for approved and active studies. If the modification or amendment proposes significant changes to the scientific components of a trial, SPRC may request that the SRC review the change and determine if it is appropriate for the trial to remain active and for the modification or amendment to be implemented. SPRC also monitors accrual to interventional trials to ensure adequate scientific progress. If accrual is not adequate, SPRC will initially work with the investigator to determine the reasons. If progress is not made and there is no reasonable expectation that changes will occur, SPRC forwards the study to SRC for consideration of closure. The MCCC PRMS is under the governance of the MCCC Clinical Research Committee, which is chaired by the Deputy Director for Clinical Research. The Clinical Research Committee reviews and approves the leadership and membership of each SRC subcommittee at least annually. It also provides guidance on standard scientific review and administrative processes for SRC and SPRC and reviews the metrics from these committees quarterly.