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Abstract:
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NIH and the Ever Changing Landscape: A Distant View from a Former Insider: NIH has long funded outcome trials. The focus has generally been on public health. Often, an intervention strategy has been evaluated as have interventions that do not necessarily have commercial value. Some recent changes are: trials done through networks; many NIH trials, including those of common conditions, are international; with success in reducing mortality and major morbidity, kinds of clinical outcomes have changed, with pressure to use surrogates, possibly affecting public health mission; emphasis on rare diseases; high cost of trials has greatly affected NIH; given the need to follow trial subjects for long times, often even after the trial is over, importance of genetic information, and concerns about privacy and confidentiality, ethical problems exist. These and other issues will be discussed.
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