The Comprehensive Cancer Center Protocol Review and Monitoring System (PRMS), an NCI-mandated activity, reviews the scientific merit, priority, and progress of all cancer clinical trials conducted at the University of Chicago, regardless of sponsorship, department, or type.
The Comprehensive Cancer Center PRMS comprises two committees:
- The Clinical Trials Review Committee (CTRC), which conducts the initial protocol review
- The Scientific and Accrual Monitoring (SAM) Committee, which is responsible for annual reviews to evaluate scientific progress and study accrual
Both are under the overall management of the Comprehensive Cancer Center Associate Director for Clinical Sciences and the Clinical Research Advisory Committee (CRAC). For cancer-related trials, institutional review board (IRB) approval is not granted until the protocol has received CTRC approval. In addition, the PRMS has the authority to close trials that do not demonstrate adequate scientific progress based on poor accrual or other factors.
Clinical Trials Review Committee
- Chair: Hedy Kindler, MD
- Vice Chair: Russell Szmulewitz, MD
The committee meets monthly (meeting and submission dates, and information about accessing forms can be obtained from the PRMS Manager, Amber Burnett — 5-0352, firstname.lastname@example.org)
The following documents must be provided to the PRMS Coordinator:
- A complete protocol and investigator brochure (if applicable). If this is a multi-institutional study coordinated by the UCCCC, the Data and Safety Monitoring (DSM) plan must include procedures for managing Serious Adverse Events (SAE's) from affiliate participating institutions.
- A completed CTRC Clinical Trials Submission Form
- A disease-specific protocol priority tree indicating where the proposed study fits relative to other open studies in that disease area or program
Protocols that have undergone external peer review, for example, NIH, ACS, or cooperative group, are eligible for expedited CTRC review, as are Compassionate Use Protocols, registry or banking studies and retrospective studies (contact the PRMS Manager Amber Burnett – 5-0352, email@example.com, for information on how to determine if the protocol is eligible for expedited review).
The CTRC review evaluates:
- Background and rationale
- Scientific objectives
- Adequacy of the study design including primary endpoints and statistical plan
- Adequacy of the data and safety monitoring plan of the protocol
- The scientific priority in the context of the priority tree, and feasibility of completion
Protocols may be:
- Approved with revisions
Principal investigators (PIs) receive a letter notifying them of the Committee’s determination, and next steps.
Scientific and Accrual Monitoring (SAM) Committee
Chair: Lucy Godley, MD, PhD
Vice Chair: Steven Chmura, MD, PhD
The committee meets monthly and studies are reviewed every 6-12 months for as long as they are actively enrolling new participants.
The SAM review assesses the overall progress of the study as well as data and safety monitoring, including:
- Rate of overall accrual (compared to the projected rate of accrual) and likelihood of successful completion
- Minority accrual
- Compliance with data and safety monitoring policies
- Past protocol audits
All data are pulled from existing sources (e.g. Velos, IRB database) and no preparation is required by the PI.
Protocols may be:
PIs receive a letter notifying them of the Committee’s determination, and next steps.