What's the potential side effects, both short term and long term, of this treatment?
For this treatment, it may be negligible, but without saying so we are only hearing one side of the story.
But for argument’s sake, there are even more sides than efficacy and safety: there are substantially different risk profiles for different potential patients, and a long acting treatment with no daily pill is more valuable for some people.
One of the reasons that long acting injectables could have a big impact on transmission in Africa is because there’s stigma around PrEP usage, especially for women. Obviously, there is now a big conversation about the cost and who pays, but the potential here is indisputable.
https://www.niaid.nih.gov/news-events/nih-statement-prelimin...
Are you aware that historically when this has happened, it almost always turns out to have negative side effects and marginal efficacy?
Don't you think an easy con is to flip a coin 3 times, and if you get heads all 3 times, tell everyone it always comes up heads, and there's no need to continue to measure it, but just to trust them?
A meta analysis of early stopping in randomized clinical trials has found no evidence that early stopping hides side effects or inflates benefit—and I challenge you to produce any examples of a phase 3 trial of an infectious disease treatment that was stopped early which later showed unduly harmful side effects for marginal benefit.
This trial showed 100% efficacy.
A major consideration of RCTs is also the benefit denied to the public by withholding a viable treatment. HIV remains a global epidemic with no existing good solutions for poor countries.
However, in adhering to the HN guidelines [0] I must "assume good faith".
And indeed, you provided an excellent, intelligent reference! Very interesting paper and debate.
In the paper the authors review the debate on early stopping, and then created a model/simulation to examine what one might expect.
I should note that the paper came out in 2016, which was before the December 2020 early stopping of the COVID vaccine trials, a real world example of an early stopping debacle, where trials were stopped and then efficacy turned out to be vastly less than originally reported (even worse than the "29% exaggeration of effect" Bassler et al originally reported).
I think your argument has convinced me that my position is not correct. However, it has not convinced me that early stopping is correct either. I think the obviously dumb thing is having these rigid trials, and a far better idea is to have real-time adjustable ongoing data collection and experimentation that never stops.
Thanks for the article. Good read!
On a side note, that number is absolutely unbelievable considering that heterosexual intercourse has a 0.08% chance of infection. Do they all have 100s of sexual partners and tens of thousands of sexual interactions before they’re 30?
Ha! Explain that to the anti-vaxxers.
"Sure. We're smart, we're scientists, we know what we're doing... except when we don't."