Raising the bar for using surrogate outcomes in drug regulation and health technology assessment

BMJ

16 September 2021 - Surrogate outcomes provide no guarantee of clinical benefit, and Dalia Dawoud and colleagues argue they should be used only as a last resort in drug trials

In June 2021, the US FDA granted accelerated approval to aducanumab for treating Alzheimer’s disease based on the drug’s amyloid reducing effects.

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Michael Wonder

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Michael Wonder