Randomized Clinical Trials and COVID-19: Managing Expectations

JAMA (published online first - free) ^ | 05/04/2020 | Howard Bauchner, MD & Phil B. Fontanarosa, MD, MBA

[Weirdad]

Despite the millions of cases and hundreds of thousands of deaths that have occurred in this devastating coronavirus disease 2019 (COVID-19) pandemic, no peer-reviewed studies of specific therapies proven to be effective in reducing mortality have been published and a vaccine is many months to years away.

To date, more than 1000 studies addressing various aspects of COVID-19 are registered on ClinicalTrials.gov, including more than 600 interventional studies and randomized clinical trials (RCTs).1

During the next few weeks and months, the results of numerous RCTs involving therapies for COVID-19 will be reported.

Indeed, preliminary results from some studies have already been reported in social media and the popular press.

How will clinicians, the public, and politicians understand the results of these much-anticipated and critically needed clinical trials?

There are then SIX points in six paragraphs, and a conclusion.

[Weirdad]

(Except is the first paragraph only (broken into lines for readability) -- it is easy to go there and read.)

This EDITORIAL came out dated today. It seems like a pretty fair commentary on how much information is coming out on "the virus." It will be hard to sort through.

When statistics are used to try to separate the wheat from the chaff, some of the chaff still falls in the pile with with the wheat. 5% or 1% or whatever cutoff is used. In 1000 studies there could easily be 10 to 50 that are wrong by dumb luck. (Though not all of the studies coming our are on treatments.)

When a study of a treatment show a benefit on a serious problem, an "NNT" (number needed to treat) of something like 5 to 10 is often considered very good. As they mention in the editorial though, most people would not consider a medicine to be very good if you have to treat 10 people in order to prevent one bad outcome, but that's usually considered a good drug if it is affordable and does not hurt you often.

I am just posting because so many here are reading rather technical things and it seemed like pretty a pretty clear essay on the topic of absorbing all the information coming out.

I do not like to "post and run" but a lot of the time I have to. Apologies that I probably will not comment a lot if this generates much discussion, but I hope it helps those of you learning to digest medical literature.

[Nifster]

I would point out that randomized clinical tests while people are dying is as stupid as it gets

Throw all known non harmful treatments you can think of at it

SARS victims responded well to hydroxychloroquine plus Z Pak and zinc

Keep using it

[BlueStateRightist]

Thanks for posting this succinct commentary. I nails home the challenges that will come with the interpreting of the current clinical trials. COVID-19 is a complex disease with different phases in its pathophysiology. Successful therapeutic intervention will depend on many factors, for example, dosing, timing, co-administered drugs and the comorbidities of the patient. Consequently, we’re going to get a firehose of data that sometimes will be contradictory.