A -- Phase 1 and Phase 2 Clinical Trials of Cancer Chemopreventive Agents

Request for Proposals (RFP) N01-CN-25000-39, entitled: Phase 1 and Phase 2 Clinical Trials of Cancer Chemopreventive Agents The Division of Cancer Prevention (DCP), of the National Cancer Institute (NCI) is seeking proposals from qualified organizations who have the ability to conduct early phase clinical trials and who have the ability to accrue a specified number of subjects per year. The main objectives of the contracts that will be awarded as a result of this solicitation will be the conduct of multiple early phase clinical trials of NCI/DCP-sponsored cancer preventive agents and the establishment of infrastructures composed of one or more collaborating institutions that will perform these trials. These contracts will replace the current Phase 1 and Phase 2 Clinical Trials of Cancer Chemopreventive Agents Master Agreement pools. The trials conducted under the new contracts will assess the cancer preventive potential of various agents by evaluating the biologic effects of these agents on their molecular targets and by determining clinically relevant correlates. Major emphasis will be on phase 2 preliminary efficacy studies, although phase 1 pharmacokinetic and safety studies as well as pilot studies exploring combinations of agents, for which individual toxicities are known, will also be supported. The agents to be studied shall include agents developed by the pharmaceutical industry and provided to the NCI for collaborative development as well as commercially available agents and agents developed by the NCI. NCI/DCP requires a total contract pool that will provide 500 to 1000 study participants accrued to phase 2 and phase 1 (if applicable) trials per year. NCI/DCP intends to make multiple contract awards under this program. The contract will consist of a base period of three years plus two option periods of one year each. The Contractor shall initiate 1 to 5 clinical trials each year, with the intent of accruing 75-150 subjects (a minimum of 75 subjects required, but with option to accrue greater numbers) into NCI/DCP-sponsored trials each year. Within each base year/period (years 1 -3) of the contract as well as within option year/period 1 and option year/period 2, the Government shall have the option to fund an additional 25 or 50 study participants (over and above the 75 patient minimum). Investigators are encouraged to work together and to seek collaborations within and outside their institutions in order to enhance their proposal. Since an individual institution may be awarded only one contract, investigators at institutions capable of performing studies in multiple organ sites are encouraged to work together to present a single proposal. Capacity to perform studies in multiple organs (i.e., more than 2) will be considered a valuable asset. The North American Industry Classification System (NIACS) code is 541710. The Request for Proposal (RFP) will be issued ELECTRONICALLY approximately March 5, 2002. The RFP will be available on the Research Contracts Branch (RCB) website at : http://rcb.nci.nih.gov Click on: Current Requests for Proposals. It is the offeror's responsibility to monitor the above internet site for the release of this solicitation and amendments, if any. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. Point of contact: Theresa H. Shroff, Contracting Officer, Prevention, Control and Population Sciences Section (PCPSS), Research Contracts Branch (RCB), NCI, 6116 Executive Boulevard, Room 205, MSC 8337, Rockville, Maryland 20852-8337. Phone: +1 (555) 000-0000; fax: +1 (555) 000-0000. ALL QUESTIONS/INQUIRIES SHALL BE SUBMITTED ELECTRONICALLY TO THERESA H. SHROFF, CONTRACTING OFFICER, AT contact@example.gov All requests for information should reference RFP No. N01-CN-25000-39. No collect calls will be accepted. 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 Government's requirement with a commercial item within 15 days of this notice.