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


P.T. 34


  Clinical Trial 


  Chemopreventive Agents 

National Institute of Environmental Health Sciences

The National Institute of Environmental Health Sciences seeks

approximately three Clinical Centers 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 and one

Coordinating Center (Request for Proposals NIH-ES-92-32).  Clinical

Centers will cooperate with the Coordinating Center and the other two

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.  Each Clinical Center

will be responsible for screening, recruitment, randomization,

treatment, developmental testing, and follow-up 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 per Clinical Center.  The estimated period of

performance is five years.  Release date of the RFP will be on or about

August 6, 1992 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-92-31 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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