Trial Design Choices Watching Dr. Yo's intervie

Trial Design Choices

Watching Dr. Yo's interview of Dr. Javitt (RLFTF) this morning.
https://www.youtube.com/watch?v=0tht5jWto4c

Couple of interesting questions/answers that relate to discussions we have had here.

Dr. Yo Asks

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In one of our earlier discussions and something that really resonated with me was the chest x-ray findings and some of the immunological markers that your team was looking at...I assume you guys are still analyzing the data and if so how much weight does the FDA put on that sort of data? Is that something that supports and confirms? Do they put a lot more weight into that?

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Dr. Javitt Answers

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That's truly supportive data. When we first approached the FDA, the FDA said if you want us to pay attention to this drug, you are going to show us that this drug affects the way patients feel, function and survive. That's what the FDA cares about and that is what the FDA should care about.

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Dr. Yo Asks

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Why did your team choose mortality at 28 days as an endpoint compared to the open label study which was at 60 days?

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Dr. Javitt Answers

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The 28 days is a historical artifact. Artifact is a big word. It's tradition. Basically all of these studies began in the 1990s when we tried to start treating ARDS. And the endpoint that has been used in all the ARDS studies and it has become the standard for anything that's followed is 28 day survival.

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I am not suggesting that the FDA shouldn't use marker data or the mortality rate shouldn't be tracked beyond 28 days by default but it's helpful to understand why these decisions were made. Perhaps this is why we have pursued symptom scores (how a patient feels). And perhaps this is why we went with 28 days (I recall Dr. Jay saying that the trial design was in part based on influenza trials).

Anyhow, interesting interview even if you aren't invested in RLFTF.