THREAD: 1. There has been a lot of back and forth on the conduct of the #Remdesivir study for #COVID19 conducted by the @NIH and several academic centers across the U.S., Europe and Asia. I thought I would share my assessment.
2. The amount of suspicion is understandable given the rapid growth of ill-conceived clinical studies and regulatory actions that have occurred recently.
3. The @NIH #Remdesivir study is not industry-sponsored. It was led by NIH & several academic partners. The investigators involved have a stellar record of scientific integrity & tremendous depth of experience in conducting & analyzing clinical trials & their ensuing data.
4. People are frustrated b/c they received topline results without study details. That is to be expected during a public health emergency. I’m sure everyone is working as fast as possible to produce a clear manuscript with all of the data, but it still takes time...
5....It wouldn’t be right to wait to share this type of information when so many patients stand to benefit. In a pandemic, every day matters.
6. Everyone wants the perfect study & they want it fast. The only way to do that in a pandemic is to be flexible. I’m not talking about pandemic exceptionalism, as some have advocated. We still need to adhere to the highest scientific and ethical standards.
7. We must realize that moving quickly means moving with some degree of uncertainty. Little was known about the natural course of #covid19 when the trial was designed & launched. Adapting endpoints in the face of new information is perfectly acceptable...
8....as long as the investigators were not aware of the data – in this case, they were still blinded to the outcomes. Again, the endpoint change was was made without knowledge of data from the trial & before interim data was available to the DSMB.
9. The findings are clinical meaningful. Shortened duration of illness for patients with advanced disease is clinically meaningful. The endpoint matters to patients.
10. What this is not: Some have compared #Remdesivir to Tamiflu. This isn't like Tamiflu, which shortens duration of illness in patients with uncomplicated flu if given v. early after disease onset.#Remdesivir shortens duration of illness by 4 days in pts with advanced disease!
11. What this is not: #Remdesivir is not a blockbuster. It will likely be superseded by more effective drugs under evaluation. But until then, it adds benefit to our patients when added to a backbone of meticulous supportive care. And they deserve it.
