Open Mike

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Open Mike Perspective: Healthy Skepticism when Focusing Solely on Surrogate Endpoints in Clinical Research

I recently wrote an essay for the NIH’s Science, Health, and Public Trust series to encourage a healthy bit of skepticism about clinical studies that solely involve surrogate end-points (e.g. changes in “biomarkers” like blood cholesterol levels or findings on an electrocardiogram).

To make my point, I described experiences with a well-known cardiovascular trial — one that focused on the risk of sudden death among heart attack survivors. I encourage readers in this essay to not just assume that treating a surrogate endpoint will automatically treat the underlying condition. Sometimes it does.  But sometimes it may not and may even cause more harm than good.

As I mention in the essay, one way to deal with this problem is to conduct more trials that focus on clinical endpoints. We should consider conducting them in innovative, efficient, cost-effective wayssuch as using pre-existing large-scale databases or “registries. I am open to hearing other thoughts and approaches which have the potential to address this challenge.

The NIH’s Science, Health, and Public Trust series is intended to provide perspectives, tools, and resources to improve the quality and usefulness of information about science and health for the public. It seeks to share strategies and best practices that might contribute to public understanding of the nature of biomedical research and its role in health.

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