CLINICAL TRIALS OF BIOLOGICAL RESPONSE MODIFIERS NIH GUIDE, Volume 22, Number 21, June 11, 1993 RFP AVAILABLE: NCI-CM-47001-64 P.T. 34 Keywords: Cancer/Carcinogenesis Biological Response Modifiers Clinical Trial National Cancer Institute The National Cancer Institute (NCI) plans to award five-year incrementally funded contracts for the performance of multiple clinical trials of biological response modifiers. Offerors will be required to demonstrate their capability to perform, within appropriate timeframes, Phase I clinical trials of biological response modifiers. Emphasis should be on excellent patient accrual, trial design, and conduct of laboratory studies of biological correlates. A theoretical (sample) laboratory and clinical protocol will be required with the proposal. The contractors will design, write, and develop clinical protocols for the biological response modifiers identified for study. The NCI will supply agents for clinical trials and hold the investigational new drugs (INDs). All contract clinical protocols will require NCI approval. Contract clinical trials will be monitored by NCI's Clinical Trials Monitoring Services. These trials will focus on initial Phase Ia/Ib studies of new biological response modifiers and on studies specifically related to issues of mechanism of action. Each contractor will perform up to three clinical trials per year. Up to three awards are planned. At least one award will be devoted to monoclonal anti-bodies and targeting agents, and at least one award will focus on biological response modifiers such cytokines and growth/differentiation factors. Beginning with each contract protocol, the contractor will submit data to Clinical Trials Monitoring Service biweekly using NCI Case Report Forms or electronic data transfer. INQUIRIES Request for Proposals (RFP) NCI-CM-47001-64 will be issued on or about June 15, 1993 and offers will be due approximately six weeks later. No telephone requests will be accepted. This procurement is unrestricted. The Standard Industrial Classification (SIC) code is 8731. No collect calls will be accepted. Requests are to be addressed to: Mr. Carl A. Newman, Contract Specialist Research Contracts Branch, TCS National Cancer Institute Executive Plaza South, Room 603 Bethesda, MD 20892 Telephone: (301) 496-8620 .
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |