The NCI Intramural Research Program (IRP) may be the source of products to be studied in both the IRP and at extramural sites. There are three scenarios and thus three levels of review under which IRP products investigators gain access to DTP and/or CTEP contract research resources.
The development of agents discovered in NCI's intramural program and anticipated to receive initial clinical trials only in the NIH Clinical Center may receive DCTD resource support for preclinical development or IND filing without consideration by the Drug Development Group (DDG) if the contract costs are fully reimbursed by intramural funds. This assumes that there is sufficient approved level of effort available on the contract for DCS use and that DCTD scientific staff are in agreement with the goals and interpretation of proposed studies.
Prior to IND filing, DDG will review clinical studies that are restricted to the IRP and that use agents for which NCI holds the IND. No extramural reviewers will participate, because the IRP is reviewed externally as part of its site visit. However, these particular proposals will be considered by the members of DDG according to the criteria described below. The DDG review provides an important opportunity for DCTD clinician-scientists to comment, in a formal way, on the suitability of the proposed agent for clinical study, and their comments will influence the priority given to NCI's filing an IND for the proposed agent.
Molecules that will be used in clinical trials in the IRP and for which NCI will sponsor use at extramural sites will be examined by extramural reviewers. Prioritization of IRP products for use of biologicals production contracts will remain with BRB-OC.