Episode 304: 303. Associations Between Surrogate Markers and Clinical Outcomes

Question What is the strength of association between surrogate markers used as primary end points in clinical trials to support Food and Drug Administration (FDA) approval of drugs treating nononcologic chronic diseases and clinical outcomes?

often surrogate markers are used as primary end points in clinical trials to support FDA approval of drugs

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Surrogate markers offer the advantage of reducing the duration, size, and total cost of trials

n 2018, the Food and Drug Administration (FDA) publicly released an Adult Surrogate Endpoint Table of more than 100 surrogate markers that may be used as primary end points in clinical trials that form the basis of traditional or accelerated approval of new drugs or biologics.

The authors evaluated Thirty-seven surrogate markers listed in FDA’s table of markers that can be used as primary end points in clinical trials across 32 unique nononcologic chronic diseases.

Most surrogate markers used as primary end points in clinical trials to support FDA approval of drugs treating nononcologic chronic diseases lacked high-strength evidence of associations with clinical outcomes from published meta-analyses.


https://jamanetwork.com/journals/jama/article-abstract/2817850