Dan L Duncan Comprehensive Cancer Center

Protocol Review and Monitoring Committee

Master
Content

All interventional cancer-related clinical trials at Dan L Duncan Comprehensive Cancer Center affiliated institutions are required to be reviewed by the Protocol Review and Monitoring Committee, also known as PRMC. This review is required for NCI-designated cancer centers, and it focuses on the protocol's scientific merit and prioritization. Subject enrollment cannot begin until both PRMC and IRB approvals have been obtained for that protocol.

Heading

Structure

Content

The Protocol Review and Monitoring Committee is subdivided into three Working Groups, overseen by an executive committee (see Organizational Chart and Roster for membership):

Heading

Cell and Gene Therapy Work Group

Content

All adult and pediatric protocols that meet one or more of these criteria are assigned 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
  • Require RAC review
Heading

Pediatric Work Group

Content

All protocols that target patients less than or equal to the age of 21 and do not involve cell or gene therapy are assigned to the Pediatric WG.

Heading

Adult Work Group

Content

All protocols that target patients over the age of 21 and do not involve cell or gene therapy are assigned to the Adult WG.

Heading

Function and Purpose

Content

The purpose of the PRMC is to provide internal, centralized oversight of cancer clinical research at all DLDCCC institutions and facilities.

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, to optimize the use of DLDCCC resources
  • Ongoing (continuing) review for accrual, changes in scientific merit, and changes in prioritization since last PRMC review
Heading

Review Process

Heading

Initial Protocol Review

Content

The PRMC reviews all interventional cancer-related clinical trials within the institutions that comprise the Dan L Duncan Comprehensive Cancer Center. All interventional clinical trials whose primary aim is cancer related, or whose primary target population is cancer patients, must receive approval from the PRMC before patient enrollment.

Protocols should be submitted using the PRMC module in BRAIN, preferably prior to or concurrent with IRB submission. Instructions for initial protocol submission are here.

The protocol will be assigned to one of the three Working Groups (WG), according to the criteria described above. The WG will review the study, and the PI will be notified of the WG's determinations and 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 from the Executive Committee.

Heading

Continuing Protocol Review

Content

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.

Instructions for continuing review submission in BRAIN are here.

Older studies (before PRMC BRAIN module) may use the coversheet linked below.

Heading

Forms and Administrative Information

Heading

Reviewer Checklist (Criteria for Protocol Review)

Content

This checklist is a reference of the criteria that will be considered while the protocol goes through PRMC review.

Heading

Meeting Schedules

Heading

Membership

Heading

Clinical Trials

Content

See available cancer-related clinical trials and learn how you can participate.