VANGUARD CLINICAL CENTERS FOR THE CLINICAL TRIAL AND OBSERVATIONALSTUDY OF THE WOMEN'S HEALTH INITIATIVE NIH GUIDE, Volume 21, Number 15, April 17, 1992 RFP AVAILABLE: NIH-WH-92-19 P.T. 34, II Keywords: Clinical Trial Hormones Risk Factors/Analysis Cancer/Carcinogenesis 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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