Protocol Review and Monitoring System

Columbia University Health Sciences, New York NY

Investigators

Linked publications, trials & patents

Abstract

The Herbert Irving Comprehensive Cancer Center (HICCC) Protocol Review and Monitoring System (PRMS) is responsible for independent scientific evaluation, prioritization, and monitoring of all cancer clinical research studies conducted at Columbia University Irving Medical Center (CUIMC). The PRMS is independent of and complements the activities of the Institutional Review Boards (IRBs) and HICCC Data Safety and Monitoring Committee (DSMC). The PRMS encompasses activities of the HICCC Disease Based Teams (DBTs), Feasibility Review, and Protocol Review and Monitoring Committee (PRMC). The Specific Aims of the HICCC PRMS are the following: (1) Provide scientific review and prioritization of all interventional (therapeutic and non-therapeutic) cancer-related clinical research protocols within the HICCC, (2) Monitor the scientific progress of ongoing studies to ensure that accrual is sufficient to meet scientific objectives, (3) Determine whether trials should continue or close for lack of scientific progress, and (4) Assess and implement the recommendations of the Data Safety and Monitoring Committee (DSMC). Review of cancer clinical research studies through the PRMS is conducted in two stages: 1. Disease Based Teams assess new trials for scientific value, fit and prioritization with existing disease-based research portfolios and feasibility review ascertains whether adequate resources are in place to conduct the trial if approved. • In 2023, 275 new trials underwent stage 1 review. 134 trials (49%) were rejected during DBT review, 9 trials (3%) were rejected during feasibility review, and 5 trials (2%) were withdrawn from feasibility and did not proceed to stage two. 127 trials (46%) were approved in stage 1 and proceeded to stage 2 review. Of the 127 trials approved in stage 1, some proceeded to stage 2 in the following year, while others were later decided by the DBTs not to be opened. 2. PRMC evaluates interventional protocols for scientific merit, innovation, and statistical soundness to assess their priority at initial submission. The PRMC also assesses the scientific and accrual progress of interventional cancer trials at the time of continuing review. • In 2023, the PRMC reviewed 93 new studies (69 full-board review, 23 expedited review) and 953 amendments. In total, the PRMC monitored 564 active interventional trials.