The primary objective of this study is to focus on the issue of cost, as well as the issue of whether the Women's Health Initiative studies have the capability to produce sufficiently reliable results to justify the investment. The Contractor shall also provide methodologic recommendations to enhance the Initiative's efficacy or to reduce costs. The results of this study shall be compiled into a formal report which will be provided to Congress. Specifically, the Contractor shall establish a committee of experts to: (1) Review the written testimony and transcript of the NIH public hearings conducted in October 1992; (2) Review the items which were included in the solicitation for the Clinical Coordinating Center and the Vanguard Clinical Centers for the Clinical Trial and the Observational Study: the draft Protocol, Uniform Cost Assumptions, Definition of Clinical Outcomes of Interest, Baseline and Follow-up Variables, the Bibliography dated 3/92, and the chart of the phases of the clinical trial; (3) Obtain input from the scientific community regarding methodology and cost; (4) Hold at least two committee meetings to accomplish the objectives in (2) and (3) above; (5) Prepare a comprehensive draft report and provide it to the Project Officer; and (6) Prepare a committee final report and deliver it to the Project Officer, Contracting Officer, and House of Representatives Appropriations Committee.
