This... is not how it's supposed to work.
> He also cautioned against “play the winner” designs that increase the number of patients being randomized to arms that show the best results in an interim analysis. “That is most often used in early phase trials, like a Phase I or early Phase II trial where you’re really trying to identify the best dose level; such trials tolerate bias pretty well,” Sietsema said. “But you wouldn’t use a play- the-winner model in a Phase III trial because the potential for bias could lead to a wrong decision and the FDA would object.”
That sums up my concerns pretty well. This is being presented as a phase III clinical trial demonstrating safety and efficacy. For the level of effect they are testing for, I don't see how an adaptive trial is appropriate here.
The bit "waiting for the trial to conclude" actually means "determine if the drug actually has any effect or not".
No matter how much you are interested in saving people's lives, or any other moralistic fallacy that might pop up, you can only help them if you give them treatments that actually work. Cutting short a study is falling short of the most basic requirement to meet that goal.
So now you are faced with a conundrum. You made sure that it has an effect to the degree you wanted. Now the math says that you either might get even surer by continuing the trial, or save 30% people from hospitalisation.
Also in treatment group just one person died while in control it was 12.
So what's it going to be? Making little bit more sure or saving few lives?
With a small enough sample, math can show that a coin flip gives tails 4 out of 5 times, specially if it's stopped too soon.
Don't you agree that stopping an experiment once we get the result we were hoping for and are looking for from the start does raise doubts regarding the conclusion?
And for a group of 1500 people it tells you how much confidence can you have. And it was more confidence than they demanded before starting the trial.
> Don't you agree that stopping an experiment once we get the result we were hoping for and are looking for from the start does raise doubts regarding the conclusion?
If you have a novel disease that's 99% fatal. And then you test a treatment that results in 30% people surviving 99% fatal disease. And you gathered enough data that that math tells you is enough to confidently claim that it isn't just a fluke.
Does stopping the trial and giving the medicine to the half of patients that you were keeping as a control group makes people raise doubts about efficacy of the drug or does that just make you not be called a second doctor Mengele?
Did they stop fluvoxamine trial? Or do they just mention that the effect was so strong that they could?
There was a single hypothesis being tested here.
The study reached its statistical significance goal, and thus the study was ended as it would be immoral beyond that point to continue to give people placebos when they knew the drug was working. I'd suggest reading up on the Tuskegee syphilis study for the ethics behind why studies are ended early once treatments have been statistically validated.