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OCR for page 105
An Assessment of the NIH Women's Health Initiative 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)
OCR for page 106
An Assessment of the NIH Women's Health Initiative 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
OCR for page 107
An Assessment of the NIH Women's Health Initiative 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
OCR for page 108
An Assessment of the NIH Women's Health Initiative 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
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