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Comment by icegreentea2 | Hacker News Reader

They are running a phase 2 trial for this right now (https://clinicaltrials.gov/ct2/show/NCT04528680?term=Sonaben...). It's scheduled to complete in late 2025. Phase 3 will probably be a few years past that, and then probably at least a year or two for approval.

That said, the clinical trial is for the combination of a drug treatment + implantable device. The implantable device itself (Sonocloud 9) has been granted fast track status by the FDA (https://www.fusfoundation.org/posts/cartheras-sonocloud-9-sy...). The fast track status should help speed up how quickly the FDA authorizes the overall treatment once clinical trials are complete.

So... completely pulling a number out of my butt, probably 5-7 years.

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Sigh

Regulation is important, but it comes with a cost.

Sometimes I wonder if we are erring too much on the side of slowing things down.

Maybe there are some efficiencies to be found, but we are talking about experimental treatments where the efficacy takes weeks to years to measure. You can't run an overnight benchmarking test.

But in saying that, if a trial is showing very positive results then it can be fast tracked, as it is unethical to withhold that kind of treatment. Conversely, plenty of trials that look good in phase I/II fail in phase III and are terminated early.

To your point, as soon as enough evidence is obtained in Phase III that the drug is better than standard of care, the trial ends early and patients in the trial get switched to it. At least, that was the case in the case studies we looked at in my lectures.

It will take 2 of those 5 years just to ascertain at what levels it is safe, and then another two years to determine whether it is better than the current standard-of-care.

While we're all desperate (some more than others) for a break-through in cancer treatment, it seems perfectly reasonable to demonstrate that something is both safe and better than the current standard-of-care before physicians start rolling this out to everyone affected by the brain tumours this therapy would help.

I sympathize with the sentiment that delaying rolling out a therapy like this seems inhumane, it would be no less (and arguably more) inhumane to roll out a therapy where we didn't establish safe doses and effectiveness to the best of our ability. Both potentially result in deaths.

You can chose to participate in clinical trails and get it before then.

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