David Fabrizio Explores Complexities of Surrogate Endpoints in Cancer Clinical Trials

The FDA has been willing to explore the utilization of surrogate endpoints like tumor response in clinical trials, but it is unclear whether these endpoints correlate with overall survival, said David Fabrizio of Foundation Medicine, Inc. However, he emphasized that overall survival does not necessarily benefit the patient if the additional days gained are not quality days.

The FDA has been willing to explore the utilization of surrogate endpoints like tumor response in clinical trials, but it is unclear whether these endpoints correlate with overall survival, said David Fabrizio of Foundation Medicine, Inc. However, he emphasized that overall survival does not necessarily benefit the patient if the additional days gained are not quality days.

Transcript (slightly modified)

How will the FDA and payers respond to having alternate endpoints in cancer clinical trials?

I think that the FDA has done a good job, as evidenced by their willingness to utilize these surrogate endpoints across a number of trials. We heard Dr. Khozin, one of my panelists [at Patient-Centered Oncology Care], speak about the adoption of looking at tumor response, a tumor shrinking versus growing, so I think that there is a willingness there and I think there’s certainly an open mind to exploring these additional options.

I think the challenge on us is whether or not these actually correlate with overall survival in the end. Of course, once you start going down that road, there’s the question of whether this truly does add benefit to a patient’s life. It’s one thing to simply add days to survival, it’s another thing to add quality days to that survival too, so that’s a completely different discussion.