Skills Lab: The Importance of the Primary Endpoint

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Dr Bishal Gyawali discusses the importance of the primary endpoint in phase 3 clinical trials.
https://www.medscape.com/viewarticle/skills-lab-importance-primary-endpoint-2025a10004v0?src=soc_yt

-- TRANSCRIPT --
Hello, everyone, this is Dr Bishal Gyawali from Queen's University, Kingston, Canada. I'm back with a new video in our Skills Lab series on how to read a phase 3 clinical trial report of cancer drugs. In our last video, we started talking about the methods section and about randomization and blinding.

Today, we'll continue with methods. The focus of the talk will be about the endpoint. Whenever we are evaluating a clinical trial, first, we need to be asking, “What is the primary endpoint of the trial?” By that, we mean what was the trial powered for? We'll be discussing power later on, but the primary endpoint is the main measure of efficacy of the drug.

This is something that is predetermined and the whole trial is designed around the primary endpoint. That's why it is important, because it also forms the basis of defining whether the trial was successful or not — that is, whether the trial met its primary endpoint or not. This will also have implications with regards to the drug approval and usage. The primary endpoint is a very important topic.

For a cancer drug, the primary endpoint should be something that measures the clinical benefit of the drug. By that, we mean how long the patient lives or how much better the patient lives. How long the patients live with a new intervention is referred to as overall survival (OS) in oncology trials. How much better the patient's life becomes is defined as improvement in quality of life.

Fundamentally, the primary endpoint of a cancer drug trial should be either OS or improvement in quality of life. Anything else is called a surrogate endpoint, because it’s not a real marker of clinical benefit for the patient. [Instead], it is something else that is supposed to reflect patient benefit.

Transcript in its entirety can be found by clicking here:
https://www.medscape.com/viewarticle/skills-lab-importance-primary-endpoint-2025a10004v0?src=soc_yt
Category
Oncology
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