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

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

I get it

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

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Episode 423: 430. Hormone Replacement Therapy and the Black Box Warning

Episode 423: 430. Hormone Replacement Therapy and the Black Box Warning

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Episode 422: 429. Rivaroxaban vs Apixaban = The Battle of the Blood Thinners!

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Episode 420: 427. Kawasaki disease-no, not the motorcycle company

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Episode 419: 426. Go Big or Go Partial? The Knee Replacement Showdown

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Episode 418: 425. Triptan initiation and cerebrovascular events

Episode 418: 425. Triptan initiation and cerebrovascular events

Kalapura C, et al. Triptan initiation and cerebrovascular events in patients with migraine: A nationwide cohort study. J Am Heart Assoc 2026 Feb 17; 15:e043409. DOI: 10.1161/JAHA.125.043409.  Today, w...

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