How to Test More Drugs

Rux ignores one of the main bottlenecks of clinical trials: finding the clinical trial managers whose expertise is necessary to manage them and surface candidates for them. Pharma would run as many trials as there are managers. And managers themselves could run trials more quickly if it was easy to find good candidate matches for a trial. LLMs are beginning to help them solve the problem of candidate discovery, since the right patients need to be a high dimensional match, and their fitness can only be discovered by perusing their EHRs for hours.

The message needs to be honed.

Subtitle of “More trials, not laxer standards” then gives an example of RBM where in-person site visits and comprehensive data validation are replaced by digital “checks”.

Ok, so “laxer standards” it is!

The key is knows which standards can be more lax without jeopardizing patient safety.

But I agree with the idea of the FDA incentivizing sponsors to leverage cost and time saving technologies. They often won’t do it themselves (or at least not quickly), but the FDA is in an ideal position to incentivize it.

Recent and related:

The Case for Clinical Trial Abundance - https://ifp.org/the-case-for-clinical-trial-abundance/

(via https://news.ycombinator.com/item?id=42462904, but no comments there)