So, so frustrating to see this.

When you don’t have control group, you really CAN’T estimate efficacy.

Controlled studies are being done (some already completed).

Let’s wait before declaring success.

Dangerous to patients to drop standard, particularly in a pandemic https://twitter.com/kidney_boy/status/1248758530578014209

In some cases, like rare disease, can use historical controls to estimate efficacy because difficult to randomize

But, COVID-19 is a new disease but NOT a rare disease. Super common now.

RCTs should remain standard for drug approval in this pandemic.

Also, note,

if a medicine is *very* beneficial (a Lazarus-like effect),

only a *small* number of patients would need to be treated in a randomized trial with controls to prove benefit

By the way, we are all glad that @GileadSciences has a medicine that might be able to be repurposed for this dreadful disease.

And super proud of fellow @MGHMedicine IM residency classmate

Dr. Diana Brainard

who is leading the charge there.

https://twitter.com/dshaywitz/status/1004196396784803840?s=21 https://twitter.com/dshaywitz/status/1004196396784803840