Dr. Bishal Gyawali explores the role of surrogate endpoints in phase 3 trials and questions their reliability in measuring real clinical outcomes.
Hello, everyone. This is Dr Bishal Gyawali from Queen's University, Kingston, Canada. Thank you for joining us on our next lecture on how to read clinical trials . We're dealing with methods and currently we're dealing with surrogate endpoints. This is going to be a big topic, so we'll have a number of lectures on this, but I highly encourage you to watch these videos in the order that they have been published on our website so that it will make sense when you join this video.
How efficient is using surrogate endpoints in clinical trials? There have been a couple of studies looking into this, which I have cited on this slide. In, they found that, compared to using OS, if you used progression-free survival , then the trial duration would shorten by an average of 11 months. If you used response rate instead of OS, you shortened the trial duration by 19 months.
What about the surrogate endpoints that have been tested and tried to be validated so far? The evidence shows that, as you can see in this graph, most of the surrogate endpoints have very low trial-level correlation — especially in the metastatic setting. There are some settings where there is a strong validation, but you can see that in majority of the cases, the validation of the correlation is pretty weak.
We need to fix this as a society, to be honest. We need to get QoL information from the patients who have been enrolling into these trials. This came from a phase 2 clinical trial, but because it was such an unprecedented survival benefit, several regulators approved this and payers paid for this. They conducted a, which was the right thing to do. I actually applaud this trial and the investigators because we see several accelerated approvals where the confirmatory trial is not done in time.
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