6 ms·

The fact that they don't have a control group is not a good sign: > Mullane, while encouraged by the University of Chicago data, made clear her own hesitancy a

by nayuki 7y ago

The fact that they don't have a control group is not a good sign: > Mullane, while encouraged by the University of Chicago data, made clear her own hesitancy about drawing too many conclusions. “It’s always hard,” she said, because the severe trial doesn’t include a placebo group for comparison. Here is some historical perspective about using placebos while people are getting infected and dying: * https://rootsofprogress.org/polio-and-the-controversy-over-randomized-clinical-trials https://rootsofprogress.org/polio-and-the-controversy-over-r... * https://rootsofprogress.org/more-on-polio-and-randomized-clinical-trials https://rootsofprogress.org/more-on-polio-and-randomized-cli...

xiphias2 7y ago
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. https://clinicaltrials.gov/ct2/show/NCT04292899 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=Remdesivir&draw=2&rank=8 https://clinicaltrials.gov/ct2/show/NCT04321616?term=Remdesi...
- glennericksen 7y ago
  Norwegia aka Norway :) "Because Indonesians come from Indonesia, and Russians come from Russia, Norwegians come from Norwegia." - Urban Dictionary
  - perl4ever 7y ago
    Recently I learned that the demonym for San Marino is "Sammarinese".
- loopz 7y ago
  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.
  - xiphias2 7y ago
    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.
- s1artibartfast 7y ago
  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.
  - xiphias2 7y ago
    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.
m0zg 7y ago
That's OK, as per Bezos Post, as long as the non-randomized study uses a drug not endorsed by the president: https://threadreaderapp.com/thread/1249738521654501379.html https://threadreaderapp.com/thread/1249738521654501379.html Democracy dies in darkness, as it were. Never mind that the study was funded by Gilead and the results were written up by a Gilead employee. No conflict of interest at all, no sir. Also quite possibly causes the same QT prolongation issues as other antivirals, including CQ/HCQ, and it's expensive AF and hard to make in quantity.
usaar333 7y ago
No it's just a sign that they aren't comfortable running a full on controlled experiment yet. Only 2 deaths out of 113 severe in a week is far better than baseline. There's also a recently released monkey study showing huge improvements, so it's more likely than not remdesivir works (https://www.biorxiv.org/content/10.1101/2020.04.15.043166v1 https://www.biorxiv.org/content/10.1101/2020.04.15.043166v1)
- perl4ever 7y ago
  Sounds promising, but have we completely ruled out the possibility that the baseline treatment causes most of the deaths?

by nayuki 7y ago

xiphias2 7y ago

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. https://clinicaltrials.gov/ct2/show/NCT04292899 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=Remdesivir&draw=2&rank=8 https://clinicaltrials.gov/ct2/show/NCT04321616?term=Remdesi...

glennericksen 7y ago
Norwegia aka Norway :) "Because Indonesians come from Indonesia, and Russians come from Russia, Norwegians come from Norwegia." - Urban Dictionary
- perl4ever 7y ago
  Recently I learned that the demonym for San Marino is "Sammarinese".
loopz 7y ago
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.
- xiphias2 7y ago
  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.
s1artibartfast 7y ago
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.
- xiphias2 7y ago
  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.

m0zg 7y ago

That's OK, as per Bezos Post, as long as the non-randomized study uses a drug not endorsed by the president: https://threadreaderapp.com/thread/1249738521654501379.html https://threadreaderapp.com/thread/1249738521654501379.html Democracy dies in darkness, as it were. Never mind that the study was funded by Gilead and the results were written up by a Gilead employee. No conflict of interest at all, no sir. Also quite possibly causes the same QT prolongation issues as other antivirals, including CQ/HCQ, and it's expensive AF and hard to make in quantity.

usaar333 7y ago

No it's just a sign that they aren't comfortable running a full on controlled experiment yet. Only 2 deaths out of 113 severe in a week is far better than baseline. There's also a recently released monkey study showing huge improvements, so it's more likely than not remdesivir works (https://www.biorxiv.org/content/10.1101/2020.04.15.043166v1 https://www.biorxiv.org/content/10.1101/2020.04.15.043166v1)

perl4ever 7y ago
Sounds promising, but have we completely ruled out the possibility that the baseline treatment causes most of the deaths?