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

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)

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

• 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

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