C

Statement of Task

The committee will review the design, organization, and operation plans of the Women's Health Initiative (WHI) to answer, at the end of a six-month period, the following questions:

  1. What was the rationale behind the choice of these particular studies? Are appropriate topics considered? Should other topics be included?

  2. Are the methodologies and the study designs appropriate to address the stated research objectives? Is the size of the study population appropriate?

  3. Are the costs accurately estimated and sufficient to reach the desired objectives?

  4. Will the study produce sufficiently reliable results to justify the costs?

To support the review and recommendation deliberations, the committee will:

  1. Review documents provided by the National Institutes of Health (NIH), including the Requests for Proposals (RFPs), responses to the RFPs by the entities awarded contracts as the Clinical Coordinating Center and the fifteen Vanguard Clinical Centers, and public testimony concerning the NIH plan;

  2. Conduct critical review of published literature appropriate for the fields of study; and

  3. Seek the counsel of recognized experts in the intervention and outcome fields of study, as well as experts in the estimation and management of cost, by way of workshops conducted concurrently with the committee meetings.

The Committee will meet three times over the six-month study period. The Committee will invite NIH scientists involved in the WHI design and investigators from the funded Coordinating Center and the Vanguard Centers to participate in workshops coincident with the first two meetings.

A final report will be delivered to the sponsor at the end of the study, with an interim copy of the final report to be delivered 14 days before public release of the report.



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OCR for page 103
An Assessment of the NIH Women's Health Initiative C Statement of Task The committee will review the design, organization, and operation plans of the Women's Health Initiative (WHI) to answer, at the end of a six-month period, the following questions: What was the rationale behind the choice of these particular studies? Are appropriate topics considered? Should other topics be included? Are the methodologies and the study designs appropriate to address the stated research objectives? Is the size of the study population appropriate? Are the costs accurately estimated and sufficient to reach the desired objectives? Will the study produce sufficiently reliable results to justify the costs? To support the review and recommendation deliberations, the committee will: Review documents provided by the National Institutes of Health (NIH), including the Requests for Proposals (RFPs), responses to the RFPs by the entities awarded contracts as the Clinical Coordinating Center and the fifteen Vanguard Clinical Centers, and public testimony concerning the NIH plan; Conduct critical review of published literature appropriate for the fields of study; and Seek the counsel of recognized experts in the intervention and outcome fields of study, as well as experts in the estimation and management of cost, by way of workshops conducted concurrently with the committee meetings. The Committee will meet three times over the six-month study period. The Committee will invite NIH scientists involved in the WHI design and investigators from the funded Coordinating Center and the Vanguard Centers to participate in workshops coincident with the first two meetings. A final report will be delivered to the sponsor at the end of the study, with an interim copy of the final report to be delivered 14 days before public release of the report.

OCR for page 103
An Assessment of the NIH Women's Health Initiative This page in the original is blank.