Protocol Review and Monitoring System

NIH RePORTER · NIH · P30 · $30,242 · view on reporter.nih.gov ↗

Abstract

PROJECT SUMMARY/ABSTRACT The Perlmutter Cancer Center (PCC) Protocol Review and Monitoring System (PRMS), internally known as the Protocol Review and Monitoring Committee (PRMC), reviews all cancer-related clinical research at PCC and NYU Langone Health (NYULH). The objectives of the PRMC are to determine whether a protocol is scientifically and statistically sound and to prioritize clinical research studies that are of the highest scientific merit, particularly those that translate PCC science and address major cancer burdens and/or disparities in our catchment area. The PRMC also evaluates whether research protocols compete with ongoing studies at PCC and evaluates the likelihood of success of the work proposed. Scientific review is conducted through a two-stage process for most protocols, with PCC Disease Management Groups (DMGs) providing the initial evaluation of the scientific merit. The PRMC evaluates protocols after DMG review with the exception of investigator-initiated trials (IITs), which have an additional review by the PCC Protocol Development and Monitoring Unit (PDMU) as a quality control measure designed to enhance the chances of success for the protocol’s approval. The PRMC also monitors ongoing clinical research studies for progress, reviewing IITs semi-annually and all other protocols annually. The PRMC has the sole authority to terminate protocols that are not demonstrating appropriate progress. PRMC review activities are coordinated with the actions of the NYU Langone Health (NYULH) IRB. These two entities have distinct functions: the PRMC focuses on the evaluation of scientific merit and progress of protocols, whereas the IRB evaluates protocols to ensure subject safety and address any ethical concerns. Both work together to promote efficient activation of clinical trials. The PRMC ensures that all cancer-related clinical trials at NYULH are appropriately designed and meet NIH policy and guidelines on the inclusion of women, minorities, and children in clinical research. Hence, the PRMC functions in an integrated fashion with the DMGs, the IRB, and other NYULH review bodies to facilitate rapid, efficient, equitable and inclusive clinical research at PCC.

Key facts

NIH application ID
10769324
Project number
2P30CA016087-43
Recipient
NEW YORK UNIVERSITY SCHOOL OF MEDICINE
Principal Investigator
Nancy Chan
Activity code
P30
Funding institute
NIH
Fiscal year
2024
Award amount
$30,242
Award type
2
Project period
1996-12-01 → 2029-02-28