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An Assessment of the NIH Women's Health Initiative (1993) / Chapter Skim
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Introduction
Pages 19-24

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From page 19...
... This 14-year, three-component project, budgeted at $625 million, is the largest single research study to be funded by NIH. As planned, it would involve 160,000 postmenopausal women at 45 clinical centers across the country and many other women residing in the communities that would participate in the Community Prevention Study.
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From page 20...
... A contract mechanism is in place for the Clinical Trial and Observational Study: a Clinical Coordinating Center and 16 Vanguard Clinical Centers began recruitment on September I, 1993; in July 1993 NTH issued a Request for Proposals for an additional 29 Clinical Centers. The Community Prevention Study, which the NTH anticipates funding through Requests for Applications under a cooperative agreement, will be administered separately.
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From page 21...
... Committee members represent expertise in the areas of epidemiology, clinical trial design and implementation, community trials, biostatistics, health education, ethics, nutrition, dietary assessment and dietary modification, hormone replacement therapy, cardiovascular disease, breast cancer, osteoporosis, and geriatrics. STATEMENT OF TASK The Statement of Task (Appendix C)
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From page 22...
... The committee chose in this context to interpret "reliable" to denote "meaningful" rather than, in the statistical sense, "repeatable." To be meaningful in terms of public health significance, findings must meet some standard of internal validity, precision, and external validity. Politics the expression of community standards and desires has been present throughout the development of the WH} and its precursor designs.
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From page 23...
... To assess whether the costs estimated are sufficient to carry out the planned design, the committee requested numerous documents from NTH, some under the Freedom of Information Act mechanism. The committee reviewed some available documents (Appendix D)
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Key Terms

  • clinical trial
  • prevention study
  • community prevention
  • vanguard clinical
  • reliable results

  • health initiative
  • observational study
  • sufficiently reliable
  • cost estimates
  • breast cancer

  • study design
  • clinical coordinating
  • cardiovascular disease
  • coordinating center
  • produce sufficiently

  • house appropriations
  • replacement therapy
  • postmenopausal women
  • hormone replacement
  • appropriations committee

  • whi clinical
  • massive investment
  • public investment
  • rapid escalation
  • dietary assessment

  • hypothesized intervention
  • focus primarily
  • funded study
  • examination data
  • contract allowing


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