Why was it even allowed? Isn't there some requirement for a trial to be called Phase 3?
A Google search resulted in this:
The third step in testing an experimental drug (or other treatment) in humans. Phase 3 trials are conducted to confirm and expand on safety and effectiveness results from Phase 1 and 2 trials, to compare the drug to standard therapies for the disease or condition being studied, and to evaluate the overall risks and benefits of the drug.
,,Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)''
The title doesn't contain Efficacy :(
A better clinical trial (but with fewer participants) will be run in Norwegia, but we're supposed to get results only in August. I don't understand why we're losing so much time by not running studies all the time.
It could simply be a challenge to enroll the severe patients in the US depending on their criteria. Tons of patients are ineligible, tons of patients are in overloaded hospitals that can't even manage the logistics of procuring masks, let alone a well controlled and documented trial.
Also, they are competing with 265 other trials actively recruiting in the US.
It is very sad that we have 150k dead people in the world (34k in US) who could have produced more than 150x (35x) the data in experiments that weren't controversial, and saved many lives. Still, we'll probably have to wait for targeted medicine to really make a difference.
Many such trials are research and require extra planning, staff, researchers and equipment. Tests need to be rigorous, documented and are coordinated and shared via WHO among all countries.
I understand the staff and equipment part, but the plans & researchers were there already in the Chinese study that was cancelled because of lack of patients in China (BTW I haven't seen any news about the cancellation of the trial, which is very sad news).
In this research it looks to me like Gilead doesn't really want to show how (in)efficient remdesivir is in reality.
From 2400 participants there would have been enough for a control arm.
A Google search resulted in this:
The third step in testing an experimental drug (or other treatment) in humans. Phase 3 trials are conducted to confirm and expand on safety and effectiveness results from Phase 1 and 2 trials, to compare the drug to standard therapies for the disease or condition being studied, and to evaluate the overall risks and benefits of the drug.
https://clinicaltrials.gov/ct2/show/NCT04292899
,,Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)''
The title doesn't contain Efficacy :(
A better clinical trial (but with fewer participants) will be run in Norwegia, but we're supposed to get results only in August. I don't understand why we're losing so much time by not running studies all the time.
https://clinicaltrials.gov/ct2/show/NCT04321616?term=Remdesi...