PHASE II - CLINICAL TRIALS OF NEW CHEMOPREVENTIVE AGENTS NIH GUIDE, Volume 26, Number 13, April 25, 1997 RFP AVAILABLE: N01-CN-75023-82 P.T. 34 Keywords: Cancer/Carcinogenesis Chemopreventive Agents Clinical Trial National Cancer Institute The Chemoprevention Branch, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI) is interested in establishing a Master Agreement (MA) pool with the objective of encouraging cancer chemoprevention clinical trails that use biochemical and biological markers as intermediate endpoints. The application of biological markers to clinical prevention trials carries great promise in relation to ultimate cancer prevention. When cancer incidence reduction itself is used as an endpoint in studies of this type, a very large number of subjects tested for long durations is often required. The design of phase 2a clinical trials will be small, short-term, efficient studies that determine the dose-response of a given chemopreventive agent on pharmacological and intermediate endpoints, the minimum dose at which this biological effect is observed, and the maximum safe dose. The second segment phase 2b study will involve a randomized, placebo-controlled, blinded trial in a small group of subjects in which the endpoint will be a modulation of a quantifiable biological effect that is correlated with cancer incidence reduction in the agent versus the placebo treated groups. This acquisition is for a five-year Master Agreement. MAA/RFP N01-CN-75023-82 will be available on or about April 28, 1997 and responses will be due on or about July 7, 1997. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the contracting officer their interest and capability to satisfy the governments requirement with a commercial item within 15 days of this notice. Following proposal submission and the initial technical review process, offerors whose proposals are judged acceptable will be awarded an MA and will then be eligible to compete for work as Master Agreement Order (MAO) RFPs are issued. INQUIRIES All responsible sources may submit a proposal, that will be considered by the agency. No collect calls will be accepted. Requests for the MAA/RFP must reference N01-CN-75023-82 and be submitted to: Ms. Michelle L. Scala Research Contracts Branch, PCCS National Cancer Institute 6120 Executive Boulevard, Room 635 - MSC 7226 Bethesda MD 20892-7226 Telephone: (301) 435-3829 Email: scalam@rcb.nci.nih.gov .
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