Ohm - thanks for posting the relevant sections - I
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Posted On: 09/22/2020 5:13:07 PM
Ohm - thanks for posting the relevant sections - I read them with a more mixed interpretation.
The "primary trial statistician" works for Amarex - there are no statisticians at CYDY. The DSMC is happy he is a non-employee, but CYDY gets no info from Amarex.
The DSMC will make a recommendation, providing CYDY the "minimum information required to make a reasoned decision." But what if the recommendation is "continue as planned?" How much will CYDY be told then?
Also note "overwhelming efficacy" is defined adjusting for having multiple (interim and final) comparisons: "methods of statistical correction [are] to be used to control the final overall Type 1 error."
I would hope the "unethical to placebo" clause would be invoked - assuming the clinical significance of the change we anticipate would be weighed along with the stat significance.
The "primary trial statistician" works for Amarex - there are no statisticians at CYDY. The DSMC is happy he is a non-employee, but CYDY gets no info from Amarex.
The DSMC will make a recommendation, providing CYDY the "minimum information required to make a reasoned decision." But what if the recommendation is "continue as planned?" How much will CYDY be told then?
Also note "overwhelming efficacy" is defined adjusting for having multiple (interim and final) comparisons: "methods of statistical correction [are] to be used to control the final overall Type 1 error."
I would hope the "unethical to placebo" clause would be invoked - assuming the clinical significance of the change we anticipate would be weighed along with the stat significance.
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