National Academies Press: OpenBook

An Assessment of the NIH Women's Health Initiative (1993)

Chapter: Appendix D: Documents Received by the Institute of Medicine from the National Institutes of Health

« Previous: Appendix C: Statement of Task
Suggested Citation:"Appendix D: Documents Received by the Institute of Medicine from the National Institutes of Health." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×

D

Documents Received by the Institute of Medicine from the National Institutes of Health

Received: March 1993

  • Solicitation (RFP) NIH-WH-92-13

    Clinical Coordinating Center for the Clinical Trials and Observational

    Dated: 3/1/72

  • Amendments to Solicitation NIH-WH-92-13

    Clinical Coordinating Center for the Clinical Trials and Observational Study of the Women's Health Initiative

    Dated: 4/22/92

  • Solicitation (RFP) NIH-WH-92-19-E

    Vanguard Clinical Centers for Clinical Trials and Observational Study of the Women's Health Initiative

    Dated 4/29/92

  • Amendments to Solicitation NIH-WH-92-19-E

    Vanguard Clinical Centers for Clinical Trials and Observational Study of the Women's Health Initiative

    Dated 4/29/92

  • Information to Offerors

    Subheadings

    Scientific Information

    Objectives

    Inclusion Criteria for Clinical Trial

    Exclusion Criteria for Clinical Trial

    Enrollment

    Key Baseline and Follow-Up Variables

    Clinical Outcomes of Interest

    Partial Factorial Design

  • Testimony from NIH Women's Health Initiative Public Hearing, October 28-29, 1991.

Received: May 25, 1993

  • May 13, 1993 Protocol (was not yet approved)

Suggested Citation:"Appendix D: Documents Received by the Institute of Medicine from the National Institutes of Health." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×

Received: May 31, 1993

  • March 8, 1993 Protocol (approved)

Received: July 7, 1993

Response to June 29, 1993 Dr. Thaul letter

  • RFP: NIH-WH-93-30

  • Business Proposals from the Vanguard Centers, with all cost information deleted

  • June 28, 1993 Protocol (approved by the Data Safety and Monitoring Board, June 16, 1993) red-lined

Received: July 9, 1993

  • Behavioral constructs

  • Description and cost information of NIH-sponsored women's health studies

Received: July 12, 1993

Additional response to June 29, 1993 Dr. Thaul letter

  • RFP: July 7, 1993

  • Power calculations and sample size information from Laurence Freedman

  • Additional quality of life construct information from Robert Kaplan

  • Journal articles on clinical trials

  • Incidence tables on colorectal cancer, hip fractures, and other fractures

Received: July 26, 1993

Additional response to June 29, 1993 Dr. Thaul letter

  • VCC levels of effort and budget information (does not include salaries)

  • Description and cost information of NHLBI-sponsored women's health studies

  • Information and costs re Women's Health Studies in NIH institutes

  • Proceedings from the October 28, 1991 Public Hearing

  • Letter from Reubin Andres on the Baltimore Longitudinal Study

  • Report on Progress: Study Design and Time Line. Memo, October 17, 1991.

Received: August 3, 1993

  • Information on the Women's Health Trial Feasibility Study in Minority Populations

  • May 13, 1991 Technical and Scientific Working Group, including:

    • Draft Proposal from NHLBI; Osteoporosis Component;

    • Draft Proposal from NCI and NHLBI;

    • Recommendations for Design of Trials;

    • NCI Biometry Branch; Recommendations for Cancer

    • Biomarker and Prevention Studies, NCI; and

Suggested Citation:"Appendix D: Documents Received by the Institute of Medicine from the National Institutes of Health." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
  • NCI Biometry Branch; Recommendations for Cancer

  • Biomarker and Prevention Studies, NCI; and

  • Repository Feasibility Information, NCI

  • NIDDK Proposal for Obesity Component (May 13, 1991)

  • Proposal by Scientific and Technical Working Group on WHI (June 4, 1991)

  • Consultant Recommendations on Endometrial Biopsies (June 27, 1991)

  • Reviews by Susan R. Johnson (On behalf of group of PEPI gynecology consultants) (July 23, 1991 and August 5, 1991)

  • Minutes of Advisory Meeting on Calcium/Vitamin D Intervention (August 15, 1991)

  • Minutes of Meeting with Expert Consultants in Epidemiology (September 13, 1991)

  • Review by ICD Directors October 17, 1991

  • Protocol Comments from Jeffrey A. Perlman, Chief, Contraceptive and Reproductive Evaluation Branch (October 22, 1991)

  • Comments on WHI Prospectus by Linda J. Golden, FDA, Center for Drug Evaluation and Research (November 20, 1991)

  • Minutes of Concept Review for Clinical Trial and Observational Study of the WHI (January 15, 1992)

  • Minutes of Hormone Replacement Working Group Meeting (January 21, 1993)

  • Minutes of Advisory Meeting for Dietary Intervention (May 10, 1993)

    Received: August 4, 1993

    Response to July 27, 1993 Dr. Thaul letter

    • Memo from Jacques Rossouw, with attachments:

      • age distribution;

      • rate calculations;

      • power calculations;

      • discussion of dietary modification and breast cancer hypothesis;

      • Hollinghead scale;

      • adjustments to minority group rate;

      • budgets for additional 6,000 WHI CT participants;

      • subcommittee membership rosters;

      • Data Safety and Monitoring Board documents;

      • memo from Mark Kestin on plasma triglycerides and a low fat diet;

      • information on why calcium and vitamin D are combined in the Clinical Trial;

      • minutes from the Concept Review meeting for the Clinical Trial and Observational Study; and

      • the scripts for the VCC videotapes.

    Additional response to June 29, 1993 Dr. Thaul letter

    • Description and cost information of NIH-sponsored women's health studies, including:

      • NHLBI; NIDDK; NCI; NINDS; NCI; NIAMS; NIDR; NIAAA; NIA; and

      • other multi-ICD-sponsored studies

    Suggested Citation:"Appendix D: Documents Received by the Institute of Medicine from the National Institutes of Health." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
    ×

    Received: August 11, 1993

    • Information on conceivable changes in scope of work

    • Information on WHI contract dates

    • Additional description and cost information of NIH-sponsored women 's health studies

    Suggested Citation:"Appendix D: Documents Received by the Institute of Medicine from the National Institutes of Health." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
    ×
    Page 105
    Suggested Citation:"Appendix D: Documents Received by the Institute of Medicine from the National Institutes of Health." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
    ×
    Page 106
    Suggested Citation:"Appendix D: Documents Received by the Institute of Medicine from the National Institutes of Health." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
    ×
    Page 107
    Suggested Citation:"Appendix D: Documents Received by the Institute of Medicine from the National Institutes of Health." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
    ×
    Page 108
    Next: Appendix E: Meeting Participants June, July, and August 1993 »
    An Assessment of the NIH Women's Health Initiative Get This Book
    ×
    Buy Paperback | $45.00
    MyNAP members save 10% online.
    Login or Register to save!
    Download Free PDF

    The National Institutes of Health Women's Health Initiative (WHI) is the largest research study ever funded by NIH ($625 million over 14 years) and is designed to test strategies to prevent cardiovascular disease, breast cancer, and osteoporotic fractures—leading causes of death, disability, and decreased quality of life for older women. Although the WHI has already begun, serious questions remain about its design, cost, and the likelihood that it can answer the questions it asks. This book evaluates whether the effort can be justified scientifically.

    1. ×

      Welcome to OpenBook!

      You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

      Do you want to take a quick tour of the OpenBook's features?

      No Thanks Take a Tour »
    2. ×

      Show this book's table of contents, where you can jump to any chapter by name.

      « Back Next »
    3. ×

      ...or use these buttons to go back to the previous chapter or skip to the next one.

      « Back Next »
    4. ×

      Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

      « Back Next »
    5. ×

      Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

      « Back Next »
    6. ×

      To search the entire text of this book, type in your search term here and press Enter.

      « Back Next »
    7. ×

      Share a link to this book page on your preferred social network or via email.

      « Back Next »
    8. ×

      View our suggested citation for this chapter.

      « Back Next »
    9. ×

      Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

      « Back Next »
    Stay Connected!