NIH GUIDE, Volume 26, Number 13, April 25, 1997


RFP AVAILABLE:  N01-CN-75023-82


P.T. 34



  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.




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




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