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Previous Volume 361:712-717 August 13, 2009 Number 7 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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The recent controversy about whether the cholesterol-lowering drug ezetimibe causes cancer raises urgent questions about the systems we use to develop drugs and medical devices and then to evaluate their safety and effectiveness.^1,2,3 There is widespread recognition that large, multinational clinical outcomes trials are essential to understanding the risks and benefits of new treatments. Although such studies are dubbed "simple," their organizational complexity entails huge investments of money, time, and energy. Given this context, the events surrounding the development and testing of ezetimibe present a useful opportunity for reflection on the future direction of the clinical research enterprise. We discuss . . . [Full Text of this Article]

Initial Approval of Ezetimibe

Studies Initiated after Completion of Pivotal Trials

Unveiling of the SEAS Results

Discussion

Source Information

From the Duke Translational Medicine Institute (R.M.C.) and the Duke Clinical Research Institute (R.A.H., M.A.B.) — both in Durham, NC.

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