Biomarkers and surrogate endpoints in randomized clinical trials

Published on October 1, 2007 Updated on September 29, 2016   36 min

Other Talks in the Category: Methods

0:00
Hello, my name is Marc Buyse. I'm the Chief Scientific Officer of the International Drug Development Institute in San Francisco. And the talk today will be about biomarkers and surrogate endpoints in randomized clinical trials.
0:15
Here is the outline of the talk. I will first define the notions that I will discuss today. First, the prognostic biomarker, second, the predictive biomarker, and third, the topic that I will spend most time on, a surrogate biomarker or surrogate endpoint. I will then discuss the statistical validation of these different types of biomarkers. I will provide examples of surrogate endpoints in oncology. And again, most of the talk will be about those examples. And I will conclude.
0:44
First, let's define some of the notions we will discuss during this talk. A clinical endpoint is a characteristic or variable that reflects how a patient feels, functions, or survives. In cancer, for example, and most of my examples will be in advanced forms of cancer, survival is the typical clinical endpoint, response to treatment may also be seen as a clinical endpoint. Although, the value of response to treatment is more arguable than the value of survival as an endpoint. Response to treatment may or may not be accompanied with a benefit to the patient. Disease or progression-free survival also are considered clinical endpoints. These definitions, by the way, were provided by the by Biomarkers Definition Working Group about 15 years ago and they are still in use today.
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Biomarkers and surrogate endpoints in randomized clinical trials

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