Interpretation of surrogate endpoints in the era of the 21st Century Cures Act

BMJ

14 January 2017 - Surrogate endpoints are commonly used in clinical trials to get quicker results, but Kevin Knopf and colleagues show how they can lead to both medical and financial harm

The rationale behind medical practice distils to three principles: maintaining health (wellbeing), improving quality of life, and extending length of life. For patients with incurable cancer, quality and length of life are of prime importance and should therefore be the primary outcome measures in all randomised clinical trials of innovative treatments. All other measures are surrogates that do not always translate into improvements in prime outcomes. This concern will only increase as the 21st Century Cures Act is implemented in the United States.

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Michael Wonder

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Michael Wonder