Clinical Research
Protocol Review and Monitoring Committee (PRMC)
All cancer-related clinical trials at Dan L. Duncan Cancer Center (DLDCC) affiliated institutions are required to be reviewed by the Protocol Review and Monitoring Committee (PRMC). Subject enrollment cannot begin until both PRMC and IRB approvals have been obtained for that protocol.
Structure
The system is comprised of the Protocol Review and Monitoring Committee (PRMC), which is subdivided into three working groups, overseen by an Executive Committee (see Organizational Chart below for membership):
- Cell and Gene Therapy (CAGT): All adult and pediatric protocols that meet one or more of these criteria must go to the CAGT WG:
- involve the infusion of whole cell or vectors designed to modify the existing genetic structure of cells in subject,
- target hemopoietic stem cell transplant patients,
- are ancillary to cell or gene therapy studies, or
- require RAC review.
- Pediatric: All protocols that target patients less than or equal to the age of 21 and do not involve cell or gene therapy.
- Adult: All protocols that target patients over the age of 21 and do not involve cell or gene therapy.
Function
The purpose of the PRMC is to provide internal, centralized oversight of cancer clinical research at all DLDCC institutions and facilities.
Initial Protocol Review
The review process is designed to ensure the highest quality of research according to following criteria:
- High scientific merit, including rationale, study design, and adequacy of biostatistical input
- Clinical feasibility
- Reasonable accrual for completion within a practical time frame
- Benefit to our patient population
Protocol Prioritization
The PRMC provides a mechanism to oversee the prioritization of competing protocols, ensuring the optimal use of DLDCC clinical resources for scientific purposes.
Continuing Protocol Review
Studies which have been approved for enrollment will be reviewed annually, or more frequently at the discretion of the PRMC. Studies will be reviewed for accrual, changes in scientific merit, and changes in prioritization since last PRMC review.
Scope
The PRMC reviews all cancer-related clinical trials at DLDCC institutions, including intervention studies (therapeutic or prevention) and screening, diagnostic, supportive care, epidemiological, ancillary, or correlative studies.
Process
Protocols should be submitted using the Initial Review Coversheet below (see coversheet for instructions), preferably prior to or concurrent with IRB submission. The working group (WG) will review the study, and the PI will be notified of the WG’s recommendation. Once the WG review is finished, the protocol will be presented to the Executive Committee for final approval. Subject enrollment cannot begin until this final PRMC approval is received.
Protocols must also be reviewed at least annually using the Continuing Review Coversheet below (see coversheet for instructions). Please submit protocols for PRMC continuing review at the same time that you submit the annual IRB review.
Forms and Administrative Information
Coversheets for Protocol Submission (with instructions):
Reviewer Checklist (criteria for protocol review):
2008 Meeting Schedules and Protocol Submission Deadlines:
PRMC Membership:
Standard Operating Procedures (SOPs)
Protocol Submission and Review Process
Clinical Trials
Please see www.clinicaltrials.gov and type in Baylor College of Medicine Cancer to retrieve the latest information on clinical trials.