Early Therapeutics Development With Phase II Emphasis

Notice Number: NOT-CA-05-014

Key Dates
Release Date: February 9, 2005

Issued by
National Cancer Institute (NCI), (http://www.cancer.gov/)

The Cancer Therapy Evaluation Program (CTEP), of the Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), is seeking, on a contract basis, organizations or consortiums with the capabilities and facilities to provide a resource for the conduct of Phase 2 and early clinical trials of NCI-sponsored agents, to evaluate biologic effects of these agents on their molecular targets, to evaluate other relevant biologic effects, and to determine clinically relevant outcomes/correlates. Major emphasis shall be on Phase 2 studies, pilot protocols that explore promising combination therapies, and high priority studies that are pivotal for drug development and require rapid initiation, completion, and data reporting. NCI staff will notify the Contractor of high priority studies as they are identified. The NCI will also consider investigator-initiated trials for credit under this contract, based on available resources and priorities.

CTEP requires a total resource that will provide 1600 to 2000 patients accrued to 32 to 64 trials per year. CTEP intends to make multiple contract awards. These contracts will require multi-institutional consortia of clinicians, statisticians, data managers, research nurses, and others with early phase clinical trial expertise with investigational agents in cancer. (It is unlikely, but not impossible, that a single institution could provide sufficient patients.) Contractors must be organized to attract adequate patient cohorts for prompt completion of trials. Contractors will have flexibility to reform consortial arrangements or to subcontract with additional sites to meet accrual goals, enhance accrual of unusual patient populations, increase accrual rates for high priority trials, and/or provide biologic/cellular pharmacology expertise for correlative studies.

Offerors for these contracts must demonstrate that they have expertise in cancer drug development, and knowledge in the clinical management of specific tumor types, Phase 2 clinical trials, pharmacology, and pharmacodynamics. They need to provide evidence of their own expertise, or access to such expertise, in diagnostic and functional imaging, interventional radiology, pathology, and other potentially relevant laboratory methodologies.

Offerors must either document the accrual of at least 150 evaluable adult cancer patients to Institutional Review Board (IRB)-approved Phase 2 trials by the investigators (including all sites in the consortium) during a recent 12-month period during the last two 2 years or document sufficient access to a minimum of 1000 new patients in a recent 12 month period to ensure accrual of at least 150 patients per year. Offerors must also document the completion and reporting of at least two Phase 2 trials completed at the offering institution/consortium during 2003-2004.

It is anticipated that up to eight awards will be made and that the resulting contracts will be awarded on an incrementally funded basis for a period of 3 years plus 2 additional option years. The Request for Proposals (RFP), N01-CM-57018-16, will be issued on or about February 3, 2005. The RFP is available at the website of the Research Contracts Branch, NCI (http://rcb.cancer.gov/rcb-internet/). The NAICS Code is 541710. Based on 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.


For further information, contact:

Annmarie L. Keane
Contract Specialist
National Cancer Institute
Treatment, Biology, and Science Section, RCB
6120 Executive Boulevard, EPS Room 6056, MSC 7193
Suite 6056
Bethesda, MD 20892-7193
Rockville, MD 20852 (for express/courier delivery)
Voice: 301-435-3814
Fax: 301-402-6699
Email: keanea@mail.nih.gov

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