Dr Bishal Gyawali discusses how to classify and define surrogate endpoints in the Skills Lab series.
Hello, everyone. This is Dr Bishal Gyawali, from Queens University, Kingston, Canada, continuing with our Skills Lab series on how to interpret the clinical trial publication well. In the past few videos, we have discussed the methods section and we touched briefly on surrogate endpoints.
First, let's talk about the goal of the RECIST criteria. Why was this developed in the first place? It was not developed to make therapeutic decisions or intended for drug approvals. The whole idea around RECIST was to help clinical trials define success or lack of success early on, without the need to wait for overall survival.The goal was to make those decisions about whether these should be tested in a phase 3, from a phase 2, and so on.
There are also some other, what I call make-believe, meaningless endpoints. For example, people talk about the clinical benefit rate, which is theoverall response rate plus the stable disease rate. The idea is that if the disease does not progress, then that's a clinical benefit. These do not correlate with any meaningful endpoint. People should not focus on the clinical benefit rate.
Pathologic complete response deserves a special mention because it's used more as a prognostic marker. It's not reliable as a predictive marker, but it's reliable as a prognostic marker. That means, irrespective of how you achieve pathologic complete response, you'll have a good prognosis. That does not necessarily mean that a drug that improves pathologic complete response will improve survival.
Let's spend some time talking about response rate because it's getting more and more frequently used in clinical trials and also as a basis for approval, but it's a very weak surrogate. The correlation with overall survival is even weaker than progression-free survival. Let’s also talk about progression-free survival. We talked about progression-free survival in the last video, but I’d also like to mentionthat there are some specific occasions where progression-free survival absolutely cannot be relied on, such as in later-line therapy trials or in situations where the prognosis is so bad that survival events happen within a year. trials, patients have a median survival of 6-8 months — and not even 6 monthsif we're talking about second or third line.
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