3 ms·

> compared to 41 hospitalizations and 10 deaths in the placebo cohort This makes me weirdly sad. Can you imagine entering the trial for a long sought drug agai

> compared to 41 hospitalizations and 10 deaths in the placebo cohort This makes me weirdly sad. Can you imagine entering the trial for a long sought drug against a deadly disease that turn out to be working, and end up in the control group? I know that there's more to it (it's necessary, they knew, it could have not worked, plainly be nocive, etc.) but it's like being unlucky twice in a row and die out of that while having received the real thing would have saved you

jpambrun 5y ago
Some patient next to them are not even offered to be part of this draw, and winning this draw (i.e. getting the real medicine) may lead to severe adverse effects. It would be unethical if this placebo was given in place of a known working alternative treatment.
- thomascgalvin 5y ago
  > It would be unethical if this placebo was given in place of a known working alternative treatment. From what little I know of cancer treatment, that isn't how studies are generally run. When you're part of a trial, you're either given the experimental treatment, or the "standard of care", not a placebo. So for cancer at least, you're either getting a novel treatment, or standard chemo.
  - epylar 5y ago
    in this case there was no standard of care
thehappypm 5y ago
Yeah, I would consider that 10 people likely did not die because they enrolled and got lucky.
ImaCake 5y ago
It is sad and unfortunately needed. You will note they stopped this study at the first “interim analysis”. One of the really important reasons such interim analyses are done is precisely to stop a trial when it so obviously works. They then switch anyone in the placebo group to the real drug. It is difficult to overstate just how much thought and argument has gone into clinical trial design in the last half century. It may seem detached and unfeeling, but basically every step is carefully considered compassion, ethics, and a desire for unambiguous causal truth of drug effectiveness.
jbrnh 5y ago
This is why the trial was stopped due to efficacy.

jpambrun 5y ago

Some patient next to them are not even offered to be part of this draw, and winning this draw (i.e. getting the real medicine) may lead to severe adverse effects. It would be unethical if this placebo was given in place of a known working alternative treatment.

thomascgalvin 5y ago
> It would be unethical if this placebo was given in place of a known working alternative treatment. From what little I know of cancer treatment, that isn't how studies are generally run. When you're part of a trial, you're either given the experimental treatment, or the "standard of care", not a placebo. So for cancer at least, you're either getting a novel treatment, or standard chemo.
- epylar 5y ago
  in this case there was no standard of care

thehappypm 5y ago

Yeah, I would consider that 10 people likely did not die because they enrolled and got lucky.

ImaCake 5y ago

It is sad and unfortunately needed. You will note they stopped this study at the first “interim analysis”. One of the really important reasons such interim analyses are done is precisely to stop a trial when it so obviously works. They then switch anyone in the placebo group to the real drug. It is difficult to overstate just how much thought and argument has gone into clinical trial design in the last half century. It may seem detached and unfeeling, but basically every step is carefully considered compassion, ethics, and a desire for unambiguous causal truth of drug effectiveness.

jbrnh 5y ago

This is why the trial was stopped due to efficacy.