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drmeow

(4,996 posts)
9. I'm not an FDA expert so there are big gaps in my knowledge but
Sun Mar 22, 2020, 09:00 PM
Mar 2020

I know that there are a few things that matter

1) Is this a brand new drug or is it a trial to test for a new use or indication for an already approved drug? The COVID-19 clinical trials are a new use for existing, already approved drugs. These are HIV and other anti-viral drugs. That makes it MUCH easier. For one thing, we know the toxicity, side effects, and contraindications for these drugs. We have a great deal of data on them already. There have already been trials at all 4 phases for these drugs. If the drug company wants to get FDA approval for the new use, the hoops are a little more involved. But if a researcher wants to test the drug for a new use but doesn't want FDA approval for new labeling, etc., there are virtually no barriers as long as the human subjects review board (IRB) considers the benefits to be greater than the risks.

2) Are there other treatments? Currently there are no known treatments for COVID-19 except symptom management. That also moves the bar. If there is an existing treatment you have to compare the new treatment to the existing treatment.

3) How lethal is the disease? This one is proving to be very lethal. That also moves the bar.

Both 2 and 3 are where hospitals are use an FDA "loophole" (if you will) known as "right to try." They can file emergency paperwork with the FDA and with their IRB to use a drug they believe will save a patient even if the drug has not been approved. This is more likely to occur with cancer drugs or emergency room situations where its the last resort.

Of course, if 1 is true then they don't need to use right to try - MDs can prescribe a drug which is FDA approved for anything if they think it will work!

4) Do we have historical data which tells us what happens without the drug? China, Italy, Iran, Seattle, New York, and Boston all provide us with data on what happens when we don't treat COVID-19 (assuming we can get China and Iran's data). That means that they can do a single arm, historical control trial. I don't know what they are doing because I haven't yet gotten the information on the trials we're involved with but my guess is that is the design they are using. It is not the perfect controlled trial but controlled trials have their own limitations related to what happens in the real world. Single arm, historical control trials are becoming more and more common because they increase real world validity of the trial without significantly reducing the outcome validity.

Target population is not really a factor, treatment vs prophylactic is.

Edited to add: Also - vaccine trials are different from treatment trials. I've never been involved in a vaccine trial.

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