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Protocol Prioritization Committee (PPC)
The purposes of the Samuel Oschin Comprehensive Cancer Institute (SOCCI) Protocol Prioritization Committee (PPC) are to identify and prioritize clinical trials that are best aligned with the mission of SOCCI, to make the best new cancer therapies available to patients, and to enhance clinical trial outcomes. Prioritization of SOCCI research goals begins within the individual clinical research program or cluster. When assessing high quality, relevant trials that meet SOCCI objectives, the PPC will ensure that studies to be conducted are also consistent with the priorities set by the clinical research program or cluster. The PPC will rank studies that are likely to succeed based on a prior feasibility assessment.
The function of the PPC is distinct from that of the Protocol Review and Monitoring Committee (PRMC), the focus of which is scientific review and protocol monitoring. Protocols are reviewed by the PPC and assigned priority scores prior to submission to the PRMC.
All studies that are required to be reviewed by the PRMC will first be reviewed by the PPC to assess feasibility and to determine if the study should be designated as high priority.
- Investigator Initiated and peer reviewed (as defined by CCSG)
- Cooperative Group studies (NCTN) and CTSU status
- Investigator initiated studies (internal or external) that meet SOCCI developmental goals
- Potential for High Scientific Output: Investigator has a leadership role; likely scientific impact
- Studies preparatory to a cooperative group (NCTN) trial
Protocol Review and Monitoring Committee (PRMC)
The Protocol Review and Monitoring Committee (PRMC) is a multidisciplinary committee responsible for peer review of all clinical research protocols at the Samuel Oschin Comprehensive Cancer Institute (SOCCI). The PRMC’s objectives are:
- to foster development of SOCCI clinical research protocols
- to assure through peer review scientific quality, feasibility, timeliness and ethics, and
- to monitor the progress of ongoing research studies
Establishment of research goals and scientific priorities begins at the Department or Division level or within each clinical or translational research program. The initial PRMC review will assess whether the protocol meets standards of scientific design, including scientific rationale, specific objectives, endpoints, biostatistical design and analysis, and the ability to accrue patients and meet endpoints. The PRMC will assess whether the data to be collected are appropriate to the study’s goals.
The PRMC has the authority to:
1) Approve or disapprove the submission of protocols to the Institutional Review Board (IRB)
2) Require modifications in any aspect of a study protocol prior to IRB submission
3) Require supplemental supporting background information before completing its’ review of a protocol
4) Monitor trial activity and if deemed appropriate request that the Principal Investigator close poorly performing studies.
The function of the PRMC is distinct from that of the IRB whose focus is on human subjects’ protection. Both PRMC and IRB approval are required, in that order, for a protocol to go forward. The objectives of the PRMC are consistent with, and derived from, the National Cancer Institute (NCI) guidelines for Comprehensive Cancer Center Grant (CCSG) designation.