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Oncology Protocol Review Committee

The Oncology Protocol Review Committee (PRC) is a multidisciplinary standing committee of the UNC Lineberger Comprehensive Cancer Center.

Its charge is the peer review of investigator initiated, industry sponsored and cooperative group research protocols involving cancer patients, or those conducted by UNC investigators with a focus on cancer, prior to submission of the protocol to the UNC Institutional Review Board (IRB).

The PRC’s primary function is to ensure the scientific merit of the proposed research and ensure patient safety parameters of proposed studies and protocol amendments. The PRC also monitors study accrual (via annual renewal review) and recommends closure of under-performing trials.

The intent of the committee is to enhance the quality of clinical cancer research at UNC by providing constructive criticism to investigators and maintaining scientific oversight of the conduct of clinical research. The committee will review all new clinical cancer trials that analyze the effect of a specific intervention prior to submission to the IRB, but will put special emphasis on protocols developed within the UNC community as externally generated national trials have already been through a peer review process.

The PRC will assess these protocols in terms of resource utilization and subject recruitment to ensure that institutional resources are being used effectively and that activation of national protocols conforms with the research aims of UNC. The committee will judge the acceptability of investigator-initiated, cooperative group and pharmaceutical company sponsored protocols based on the following factors:

  1. Background data justifying the proposed research
  2. Scientific design and merit
  3. Risk/benefit ratio
  4. Biostatistics
  5. Feasibility
  6. Resource utilization
  7. Application format

On an annual basis the committee will review investigator-initiated, cooperative, and pharmaceutical company sponsored renewal applications which are actively recruiting subjects or include subjects still on active treatment. The committee will judge the acceptability of the continued research based on rate of subject accrual, risk/benefit ratio, and institutional interest.

Institutional trials will be audited periodically as described in the UNC Lineberger Audit Policies and Procedures. The PRC will be responsible for determining the necessary actions following audits of internal trials.