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Concluding Remarks
Pages 85-90

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From page 85...
... NIH has provided a justifiable rationale for the diseases selected for study in the WHI. These diseases are important causes of morbidity and mortality among women in the United States; they merit further research to test the efficacy of preventive measures and to develop effective programs that educate and motivate women to adopt proven prevention strategies.
From page 86...
... To determine whether the proposed methods for the CT were appropriate for the stated research objectives, the committee analyzed the assumptions underwing the methods for each hypothesis and identified the major threats to the successful achievement of each hypothesis. The committee then weighed the risks of an unsuccessful trial against the potential benefits of additional information to be learned from a successful trial.
From page 87...
... NTH incurred for other clinical trials conducted over the past 20 years, they are very low relative to the costs of more recently conducted comparable trials. As noted earlier, the committee believes that the total costs of the CT will be greater than the $625 million provided by NTH.
From page 88...
... Whatever the merits of the WHT, the committee has no doubt about the need for a substantial investment in research on women's health. SOCIETAL CONTEXT The committee contemplated the societal context of the WHT throughout its more focused discussions of study rationale, design and methods, and cost, specifically the following issues: efficacy and effectiveness, public health choice versus individual choice, and considerations beyond science.
From page 89...
... Then, additional studies on the effectiveness of lifestyle interventions must develop methods generalizable beyond clinical trial volunteers. The committee assumes that NTH would continue to fund such a range of studies as part of its overall research agenda.
From page 90...
... should proceed, and why canceling it would unleash disasters. If it is cancelled, some argued, no one would ever trust the government again; it would prove that the government does not really care about women's health; it would so greatly disappoint the community which has gathered around this project that it will be impossible to ever galvanize them again; it would be seen as an unwelcome political blow to those in Congress who have pressed for more women's health research.


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