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 391: 402. Functional disability after clinically significant extracranial bleeding: a secondary analysis of ASPREE

Episode 391: 402. Functional disability after clinically significant extracranial bleeding: a secondary analysis of ASPREE

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Episode 390: 401. Add-On Treatment With Zilebesiran for Inadequately Controlled Hypertension

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Episode 389: 400. CRP, Lipoprotein A, LDL for cardiac risk assessment

Episode 389: 400. CRP, Lipoprotein A, LDL for cardiac risk assessment

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Episode 388: 399. Use of albumin-adjusted calcium measurements in clinical practice

Episode 388: 399. Use of albumin-adjusted calcium measurements in clinical practice

Desgagnés N et al. Use of albumin-adjusted calcium measurements in clinical practice. JAMA Netw Open 2025 Jan 21; 8:e2455251. (https://doi.org/10.1001/jamanetworkopen.2024.55251)Overall, total calcium...

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Episode 387: 398. Which is Better, Tirzepatide or Semaglutide?

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Episode 386: 397. What is the new drug for smoking cessation?

Episode 386: 397. What is the new drug for smoking cessation?

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Episode 385: 396. Vitamin D and Kids (CME)

Episode 385: 396. Vitamin D and Kids (CME)

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Episode 384: 395. How accurate is the BMI?

Episode 384: 395. How accurate is the BMI?

Aryee EK et al. Prevalence of obesity with and without confirmation of excess adiposity among US adults. JAMA 2025 Apr 17; [e-pub]. (https://doi.org/10.1001/jama.2025.2704)The rate of obesity was 39.7...

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