NIH GUIDE, Volume 21, Number 15, April 17, 1992


P.T. 34, II


  Clinical Trial 


  Risk Factors/Analysis 


  Cardiovascular Diseases 

  Musculoskeletal System 

National Institutes of Health

The National Institutes of Health seeks approximately 15 Vanguard

Clinical Centers for the Clinical Trial (CT) and Observational Study

(OS) components of the Women's Health Initiative.

CT objectives are to test the benefits and risks of hormone replacement

therapy, dietary modification, and supplementation with calcium plus

Vitamin D on the overall health of U.S. post-menopausal women ages

50-79. Approximately 57,000 women will participate in the various

components of the Clinical Trial.

OS goals are to:  (1) improve risk prediction of coronary heart

disease, breast cancer, fractures, and total mortality in

postmenopausal women; (2) examine the impact of "spontaneous" changes

in characteristics on disease and total mortality; and (3) create a

resource of data and biologic samples that can be used to unearth new

risk factors and/or biomarkers for disease.  The OS cohort will

comprise approximately 100,000 U.S. women.

The Vanguard Clinical Centers shall cooperate with a Clinical

Coordinating Center in developing, testing, and refining the overall

program and in writing the final protocol, Manual of Operations, and

training materials before recruitment commences in the approximately 15

Vanguard Centers and in approximately 30 additional Clinical Centers.

A separate solicitation will be issued at a later date for these

additional Clinical Centers.  Each Vanguard Clinical Center shall be

responsible for screening, recruitment, randomization, and follow-up of

approximately 1,270 CT participants and 2,222 OS participants (with a

minimum of 1,000 CT and 2,000 OS).

This is not a Request for Proposals (RFP).  RFP NIH-WH-92-19 will be

available on or about April 20.  Proposals will be due on or about June

15, 1992.  All responsible sources may submit a proposal that will be

considered.  No collect calls will be accepted.

A copy of RFP NIH-WH-92-19 may be obtained by written request,

including two self-addressed mailing labels, to:

National Institutes of Health

WHI, Research Contracts Branch, DCG

Federal Building, Room 1C11

Bethesda, MD  20892


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