NIH GUIDE, Volume 22, Number 21, June 11, 1993


P.T. 34



  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.


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


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