Question: is it not a standard procedure to stop a Phase III trial early when the statistics warrant it? Isn't this a pretty cut-and-dried statistical question? Naively I would think that there's nothing controversial about ending a trial early, isn't that the ethical thing to do?
I guess the political maneuvering angle before the election complicates all of that, but if the Trump administration is really willing to actually fabricate Phase III trial data, then why trust anything regardless of whether or not the Phase III trial "completes" or not?
The statement does not actually commit these companies to completing the entire Phase III trials regardless of outcome. The relevant paragraph from this article (with quote) is:
> In a statement, the companies pledged to “make the safety and well-being of vaccinated individuals our top priority.” The vaccine developers said they would continue to impose high ethical and scientific standards on the vaccine-testing process, and apply for government authorizations only “after demonstrating safety and efficacy through a Phase 3 clinical study.”
"Through" in that last quote is being taken to mean "at the completion of". But it can also mean "through the use of."
I disagree with the headline that Stat put on their article. To me it seems clear that the commitment from these companies is to the quality of the process, not a particular rigid timetable.
Edit - here is the full statement for those who want to read it.
If the statistics warrant it then yes, but for a vaccine, even waiting to finish these trials is an incredibly rushed schedule. This isn't even about stopping the trial early - this is about approving it conditionally before the trial is done and then waiting for the trial to end to really approve it. I don't think the concern is about fabricating phase III data. The concern is that extreme political pressures mean no matter what the interim results say, the FDA may feel inclined to approve the vaccine. Considering that we need healthy people to willingly take these vaccines to end the pandemic, losing that trust in the process would be devastating. People need to believe that the FDA approved it because the evidence shows the vaccine is most likely effective without safety concerns. If they don't, then they won't take it, and if the vaccine then fails phase III, its not clear how you regain that trust as a regulatory agency.
> This isn't even about stopping the trial early - this is about approving it conditionally before the trial is done and then waiting for the trial to end to really approve it
I see -- yea totally agree, I thought they were committing to a rigid timetable or something but that's not what's happening here as you say.
Yeah - its some unprecedented stuff for a vaccibe. One important thing to remember is that its impossible to test two important factors for vaccines in a short trial - long term side effects and durability of the immunity. I mean, it's not physically impossible. You could take a few hundred participants, vaccinate them, put them on a ship going at some percentage the speed of light, and then see if they have any side effects and do a challenge study to see if they're still immune. Short of playing with the fabric of space time (and ethics) - you're not really getting that data from any of these trials, which is why as I mentioned even with completed trials this timeline js unprecedentedly short.
Vaccines are a bit different than "cures" for stopping trials.
If you test drug XYZ and after a while it's clear that far more people in the control group die, you quickly declare XYZ proven effective, stop the trial, and give XYZ to the control group to save as many lives as possible.
For vaccines there are no such dramatic effects. Everyone in the study is healthy, at least to begin with, so there is no tragedy to avert, and you can let the study keep going even after it starts becoming clear that the vaccine is good.
At least in theory. I don't know the actual bureaucratic protocols.
The usual protocols have been well and truly thrown out the window, so I don't know what the comparison point would be. Moderna didn't even finish animal trials before giving their vaccine to humans.
My understanding is that the data has to be overwhelmingly good to stop the trial early.
I suspect the Trump administration's ability to actually fabricate trial data would be pretty limited without collateral damage (i.e. whistleblowing). Their ability to push it out of Phase III prematurely however is more debatable.
I don't think they typically stop the trial as much as they go to the FDA for emergency authorization with data from their midpoints showing overwhelmingly positive effects to get approval to proceed to Phase 4, while still finishing Phase 3. It's meant to compress the timeline, not to skip steps.
I guess the political maneuvering angle before the election complicates all of that, but if the Trump administration is really willing to actually fabricate Phase III trial data, then why trust anything regardless of whether or not the Phase III trial "completes" or not?