My understanding of DSMC and Dr. Pourhassan's disc
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Posted On: 08/01/2020 4:42:40 PM
Re: reallypeople? #46593
My understanding of DSMC and Dr. Pourhassan's discussion is that they evaluate with three possible outcomes:
1. Leronlimab is severely injurious to trial patients and trial is stopped due to risk to patients.
2. Leronlimab is acceptably safe and trial continues.
3. Leronlimab is so overwhelmingly effective versus placebo that is ethically inappropriate to continue trial. Trial is concluded with positive result and placebo patients are given Leronlimab.
I may have the details exact, but that is my understanding.
As the 28 day primary criteria is dead/not dead, the results and DSMC decision should be received Tuesday or Wednesday, if I recall correctly from Thursday's call.
1. Leronlimab is severely injurious to trial patients and trial is stopped due to risk to patients.
2. Leronlimab is acceptably safe and trial continues.
3. Leronlimab is so overwhelmingly effective versus placebo that is ethically inappropriate to continue trial. Trial is concluded with positive result and placebo patients are given Leronlimab.
I may have the details exact, but that is my understanding.
As the 28 day primary criteria is dead/not dead, the results and DSMC decision should be received Tuesday or Wednesday, if I recall correctly from Thursday's call.
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