NIH GUIDE, Volume 21, Number 27, July 31, 1992


P.T. 34


  Clinical Trial 


  Data Management/Analysis+ 

National Institute of Environmental Health Sciences

The National Institute of Environmental Health Sciences seeks a

Coordinating Center for a clinical trial, the Toxicity of Lead in

Children Trial.  The objective of the trial is to test the use of the

drug succimer in preventing lead-induced developmental delay.  Children

eligible for the trial will be about two years old and will be followed

until they are at least four.  The trial will be double blind to the

extent possible.  The target lead levels will be between about 20 ^g/dl

to 45 ^g/dl.  All children thought to be eligible will be treated for

iron deficiency, be given vitamin and mineral supplementation, and have

dust control measures instituted in their homes.

It is anticipated that there will be three Clinical Centers (Request

for Proposals NIH-ES-92-31) and one Coordinating Center.  The

Coordinating Center will cooperate with the three Clinical Centers in

developing, testing, and refining the overall program and in writing

the final protocol, Manual of Operations, and training materials before

recruitment commences.  The Coordinating Center will plan randomization

of study subjects.  Optimally, no more than three Clinical Centers will

randomize to drug or placebo on the order of 1000 total children during

a 1-year enrollment and treatment phase.

The Government estimates that an average of five professional FTEs, two

technical FTEs, one clerical FTE, and one other FTE will be required on

an annual basis.  The estimated period of performance is six years.

Release of the RFP will be on or about August 6 with proposals due

November 4, 1992.  All responsible sources may submit a proposal that

will be considered by the agency.

Requests for the RFP must reference RFP NIH-ES-92-32 and must be

forwarded to:

National Institute of Environmental Health Sciences

Contracts and Procurement Management Branch

ATTN:  Thomas M. Hardee, Contracting Officer

79 T.W. Alexander Drive, 4401 Building

P.O. Box 12874

Research Triangle Park, NC  27709

Telephone:  (919) 541-7893

FAX:  (919) 541-2712


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