ADDITIONAL CLINICAL CENTERS FOR THE CLINICAL TRIAL AND OBSERVATIONALSTUDY OF THE WOMEN'S HEALTH INITIATIVE- EAST/WEST



NIH GUIDE, Volume 22, Number 22, June 18, 1993



RFP AVAILABLE:  NIH-WH-93-30 E/W



P.T. 34, II



Keywords:

  Hormones 

  Risk Factors/Analysis 

  Nutrition/Dietetics 

  Biological Markers 



National Institutes of Health



The National Institutes of Health (NIH) seeks approximately 29

additional Clinical Centers for the Clinical Trial (CT) and

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



The CT objectives are to test the benefit and risk of hormone

replacement therapy, dietary modification, and supplementation with

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

age 50 to 79.  Approximately 57,000 women will participate in the

various components of the Clinical Trial.



The 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 involuntary 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 be

comprised of approximately 100,000 U.S. women.



The additional Clinical Centers will cooperate with a Clinical

Coordinating Center, the Vanguard Clinical Centers, and the Project

Officer in implementing the overall Clinical Trial and Observational

Study.  Each additional Clinical Center will be responsible for

screening, recruitment, randomization, and follow-up of approximately

1,270 CT participants and 2,220 OS participants.



This is not a Request for Proposals (RFP).  RFP NIH-WH-93-30 E/W will

be available on or about June 30.  Proposals will be due on or about

August 31, 1993.  All responsible sources may submit a proposal that

will be considered.



INQUIRIES



A copy of RFP NIH-WH-93-30 E/W 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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