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;
(6)Resource utilization and
(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 LCCC Audit Policies and Procedures. The PRC will be responsible for determining the necessary actions following audits of internal trials.