4 ms·

Pardon my naive question, but aren't there more objectives for the clinical trial? Particularly testing for negative side effects? How are those judged if the t

Pardon my naive question, but aren't there more objectives for the clinical trial? Particularly testing for negative side effects? How are those judged if the trial is discontinued?

maxerickson 5y ago
Safety continues to be evaluated during Phase 3 (and after approval), but trials don't proceed to Phase 3 without establishing some reasonable baseline for safety in the earlier phases.
sudosysgen 5y ago
You don't need people to actually have covid to find side effects. So you don't need sick people in your control arm.
- CydeWeys 5y ago
  To be cleared though, both arms or the trial are people who have COVID. The control arm is not getting the drug. If there are side effects that occur in some combination with having COVID, they will find those.
akiselev 5y ago
Data on the most obvious side effects are collected in the first phase which is a very small group of healthy patients who take the drug under medical supervision in increasing doses until the side effects are so bad they can't keep going. They use this data to establish safety limits for the rest of the clinical trial and continue monitoring the situation until well after the drug is approved.
mbreese 5y ago
This was a phase 2/3 trial. So there was some side effect data collected, but enough people went through the trial to see any large/common side effects. I generally think of the phases like this (this is just how I think of it): Phase 1 - is it safe? If you don’t see severe toxicity then you can go to phase 2. Phase 2 - does it work? You look for good outcomes (cures, better survival, etc). If there is significantly better outcomes relative to placebo, then go to phase 3. Phase 3 - does it work for a large population? What is the appropriate dose? Dialing in the numbers before public release. Phase 4 - after you’ve made the drug public, monitor the larger population for side effects or adverse events. You can’t hope to cover all patients in a phase 2/3 trial, so you keep monitoring the first waves of patients that get the drug.

Pardon my naive question, but aren't there more objectives for the clinical trial? Particularly testing for negative side effects? How are those judged if the trial is discontinued?

maxerickson 5y ago

Safety continues to be evaluated during Phase 3 (and after approval), but trials don't proceed to Phase 3 without establishing some reasonable baseline for safety in the earlier phases.

sudosysgen 5y ago

You don't need people to actually have covid to find side effects. So you don't need sick people in your control arm.

CydeWeys 5y ago
To be cleared though, both arms or the trial are people who have COVID. The control arm is not getting the drug. If there are side effects that occur in some combination with having COVID, they will find those.

akiselev 5y ago

Data on the most obvious side effects are collected in the first phase which is a very small group of healthy patients who take the drug under medical supervision in increasing doses until the side effects are so bad they can't keep going. They use this data to establish safety limits for the rest of the clinical trial and continue monitoring the situation until well after the drug is approved.

mbreese 5y ago

This was a phase 2/3 trial. So there was some side effect data collected, but enough people went through the trial to see any large/common side effects. I generally think of the phases like this (this is just how I think of it): Phase 1 - is it safe? If you don’t see severe toxicity then you can go to phase 2. Phase 2 - does it work? You look for good outcomes (cures, better survival, etc). If there is significantly better outcomes relative to placebo, then go to phase 3. Phase 3 - does it work for a large population? What is the appropriate dose? Dialing in the numbers before public release. Phase 4 - after you’ve made the drug public, monitor the larger population for side effects or adverse events. You can’t hope to cover all patients in a phase 2/3 trial, so you keep monitoring the first waves of patients that get the drug.