- Feasibility Review Committee (FRC)
- Protocol Review and Monitoring Committee (PRMC)
- Data and Safety Monitoring Committee (DSMC)
Feasibility Review Committee (FRC)
The Feasibility Review Committee provides support and additional information to the PRMC to facilitate a comprehensive, informed assessment of Sylvester interventional research studies. The FRC reviews and assesses each study for operational conduct and ability to meet accrual goals.
The committee reviews:
- Study funding
- Appropriate support staff
- Nursing and Chemotherapy Treatment Unit (CTU) resources
- Patient population
- Radiology, pathology services, and research pharmacy
- Procedures, operations, and related logistics (including feasibility to be conducted at satellite sites)
- Data Safety Monitoring Plan (DSMP)
The committee conducts reviews as required and provides recommendations to the PRMC.
For additional information please contact: frc@miami.edu
Faculty
Jose Lutzky, M.D.
FRC Chair
Philip Arlen, Ph.D.
FRC Vice Chair
Protocol Review and Monitoring Committee (PRMC)
The PRMC provides internal scientific merit oversight of all cancer studies and assures that center resources are efficiently engaged to facilitate best practices for scientific endeavors. All cancer-related studies that involve human subjects, including both cancer patients and healthy populations, are submitted to the PRMC for review.
PRMC scientific review takes into account the specific rationale, study design, availability of adequate numbers of patients or subjects, the presence of any competing studies, and the robustness of biostatistical design, assuring internal oversight of the scientific merit for all cancer studies. The main objectives of the PRMC are to:
- Provide timely review of the scientific merit of all cancer research studies.
- Ensure prioritization of cancer research studies according to Sylvester's scientific objectives, including catchment area relevance.
- Monitor the scientific progress of all cancer research studies with an emphasis placed on timely accrual.
- Review the study-specific data and safety monitoring plan.
The PRMC exercises its authority to terminate studies not meeting scientific goals or the PRMC accrual monitoring policy.
PRMC processes ensure all Sylvester research studies meet high scientific standards, specific aims, study endpoints and design, proposed analysis, ability to accrue subjects, and plans for data and safety monitoring. PRMC approval is required for all cancer studies involving human subjects prior to IRB submission.
Studies requiring full committee review include:
- Investigator-initiated studies (IISs) developed by University of Miami faculty with funding from the institution, a non-peer reviewing agency, or industry.
- Multi-institutional IISs where the study Pl is at another non-NCI-designated institution, and the study has not undergone formal peer review (as outlined in the expedited review criteria below).
- Pharmaceutical studies where the concept and protocol originate with industry.
Studies eligible for expedited review by the Chair or Vice-Chair include:
- NCTN and NCI Cancer Therapy Evaluation Program-approved studies.
- IISs that have or will receive external peer review by an approved NCI peer-review funding organization prior to activation.
- Multi-site 11Ss previously approved by an NCI-designated Cancer Center PRMC.
- Prospective, hypothesis-driven, non-interventional studies (e.g., observational, ancillary, and correlative studies).
Studies exempt from PRMC review include:
- Non-hypothesis-driven research such as chart reviews, registries, databases, general bio-banking studies, or single-subject compassionate use studies.
To submit studies to the PRMC via OPERA please click here: pes.sylvester.org.
Fee Schedule
PRMC fees are applicable to all cancer-related studies supported by for-profit sponsors and/or agencies/foundations that do not otherwise cover PRMC fees through federal indirect costs to the cancer center.
PRMC scientific review is a mandatory requirement instituted by the National Cancer Institute (NCI) for all cancer-related clinical trials. NCI policies dictate that the PRMC must review, at a minimum, all research studies in areas of diagnosis, therapy, prevention, and control of cancer that have not received traditional peer review for scientific merit.
PRMC Review
Fee Amount: Initial Review $1,500
This fee includes:
- Annual Accrual Monitoring
- Annual Scientific Progress & Performance Review
- Amendment Review(s)
Faculty
Craig Moskowitz, M.D.
PRMC Chair
Matthew Abramovitz, M.D.
PRMC Vice-Chair
Sandra Rossi
PRMC Manager
Emily Holmes
PRMC Manager
Data & Safety Monitoring Committee
All clinical studies conducted at Sylvester must include provisions for data and safety monitoring. The DSMC conducts data and patient safety reviews on cancer related institutional, interventional studies that entail risk(s) to participants. Protocols that are externally peer reviewed by the NIH, NCTN and the NCI, CTEP do not require additional data and safety monitoring at the institutional level.
The Sylvester DSMC evaluates all new investigator-initiated studies to ensure patient safety monitoring is commensurate with risk.
The DSMC is responsible for:
- Protecting participant safety
- Ensuring the credibility and integrity of the data
- Providing analysis of efficacy data and interim reviews of safety monitoring
The DSMC is composed of experts in relevant scientific disciplines to ensure critical data and safety review of all cancer related institutional, interventional studies. The committee comprises medical oncologists, scientists, nurses, clinical research coordinators, regulatory analysts a statistician, and a pharmacist.
Faculty
Cristiane Takita, M.D., MBA
DSMC Chair
Alejandra Perez, M.D.
DSMC Vice-Chair