Important statement from RECOVERY Trial in UK about continuing RCT of hydroxychloroquine. @texhern @HeartBobH @gcfmd @PCORnetwork @ASlavitt https://www.recoverytrial.net/files/professional-downloads/recovery_noticetoinvestigators_2020-05-24_1422.pdf

I certainly agree with @US_FDA that HCQ should be reserved for use in properly designed adequately powered RCTs rather than used based on belief in absence of evidence. Multiple well-designed RCTs are underway.

But, frankly i'm disturbed by the number of highly health literate people (including some regulators) who look at observational studies and pronounce that the evidence in already in. Importantly, the ongoing RCTs have independent data monitoring committees.

These committees look at the data and determine whether the balance of benefits and risks to the participants has reached a threshold to either continue or stop the trial. There are multiple ongoing trials so many committees are looking at high quality data.

I'm sure they are looking more intensively with all the publicity. But even the large Lancet study concluded that RCTs are needed to answer the question of potential benefits weighed against risks. Collaboration among DMCs would probably be a good thing.

We have seen many examples of wrong answers from observational treatment comparisons. The methodology of non-randomized real world evidence is improving, but none of the published studies have been able to meet quality measures for design for causal inference.

And best have all concluded: RCTs are needed. So, let's get a definitive answer from RCTs asap rather than jumping to conclusions one way or another. Random assignment is a gift for which we should be grateful as we seek truth.

Finally, none of this implies that i know whether HCQ is beneficial (or net detrimental) for COVID-19. I will be happy if it is beneficial and sad for patients of not, but i will be happy for biomedical science if we get a definitive answer, positive or negative.