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

Jaksot(385)

Episode 407: 415. Do Air Filters Lower Blood Pressure?

Episode 407: 415. Do Air Filters Lower Blood Pressure?

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Episode 406: 414. Resistant Hypertension, Physical Therapy, Steroids for Pneumonia

Episode 406: 414. Resistant Hypertension, Physical Therapy, Steroids for Pneumonia

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Episode 405: 413. 4 Articles to Scare You-- COPD, Cirrhosis, ETOH, and Ablation

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gabapentin may increase COPD exacerbationsBenzo for ETOH might be long gone..guess what is going to replace itAnticoagulation after ablation.... what do you do with it?BBlocker in those with cirrhosis...

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Episode 404: 412. Liver Transplant - The One Referral I Doubt You Are Doing Correctly

Episode 404: 412. Liver Transplant - The One Referral I Doubt You Are Doing Correctly

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Episode 403: 411. Gabapentin and Emergency Carotid Artery Stenting in Stroke

Episode 403: 411. Gabapentin and Emergency Carotid Artery Stenting in Stroke

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Episode 402: 410. When You Shouldn't Double Down But Instead Hit for Another

Episode 402: 410. When You Shouldn't Double Down But Instead Hit for Another

This massive meta-analysis of 484 randomized, double-blind, placebo-controlled trials (104,176 participants) quantified the blood pressure–lowering effects of major antihypertensive drug classes and t...

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Episode 401: 409. The Effects of Upper Extremity and Lower Extremity Aerobic Exercise Training in Patients with Peripheral Arterial Disease:

Episode 401: 409. The Effects of Upper Extremity and Lower Extremity Aerobic Exercise Training in Patients with Peripheral Arterial Disease:

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Episode 400: 408. CME Obesity and MASH

Episode 400: 408. CME Obesity and MASH

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