Protocol Review and Monitoring System

Roswell Park Cancer Institute Corp, Buffalo NY

Investigators

Linked publications, trials & patents

Abstract

ABSTRACT – PROTOCOL REVIEW AND MONITORING SYSTEM The overall goal of the Protocol Review and Monitoring System (PRMS) is to promote rigorous review of the scientific merit, priorities, and progress of all clinical research, and to ensure that adequate resources are available at Roswell Park for such research. To address this goal, PRMS employs 3 Specific Aims: 1) Develop and determine the feasibility and prioritization of protocols; 2) Review protocols for scientific merit, study design, catchment area needs and relevance to the mission of Roswell Park; and 3) Track and evaluate safety, quality, ongoing scientific relevance and accrual progress of each study. Operationally, the PRMS manages protocol prioritization, scientific review, operational implementation and scientific progress of protocols through its committees and charters. PRMS is comprised of four components, the Clinical Disease Teams (CDTs), the Operational Feasibility Committee, the Scientific Review Committee, and the Data and Safety Monitoring Committee. CDTs are responsible for prioritization of disease specific therapeutic interventional trials, with emphasis on prioritizing studies related to cancers seen in the catchment area and to improve inclusion of minoritized populations, as well as ongoing scientific relevance of the existing trials. The Operational Feasibility Committee assures adequate resources are available for each protocol. The Scientific Review Committee (SRC) performs reviews on the scientific merit of each protocol and determines alignment with the scientific priorities for Roswell Park. In addition, the SRC evaluates the degree of risk associated with each protocol and monitors progress from recruitment to completion of clinical research. The SRC has the authority to terminate protocols that do not demonstrate sufficient progress. Roswell Park continually strives to improve its processes and operations to maximize efficiency and ensure all clinical research meets high scientific standards. In the previous funding period multiple procedural changes were made that improved efficiency and refined scientific review. These changes included implementation of disease site protocol prioritization and portfolio management by CDTs, biannual review of disease site portfolios and closure of low or slow accruing studies that did not involve rare diseases, and continuing assessment of catchment area relevance. These procedural changes have been instrumental in achieving a decreased time to SRC approval. The median time from submission to final SRC approval for all trials decreased from 38 days in 2018 to 19 days in 2022. The number of days from activation date to the first accrual date decreased from 69 days in 2018 to 35 days in 2022. Clinical Research Services, which is the implementation arm of PRMS, provides Protocol Editors, who assist investigators in refining their protocols, assuring all required elements are included and improving the overall quality of protocols submitted. and resources including templates, process instructions, and guidelines, and links to the NCI Common Toxicity Criteria for Adverse Events, NCI Response Evaluation Criteria in Solid Tumors (RECIST), and Investigational New Drug exemption criteria.