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Re: crudeoil24 post# 162

Friday, 04/16/2021 4:35:06 PM

Friday, April 16, 2021 4:35:06 PM

Post# of 545
So what exactly does the news mean?

I have never heard of a DSMB recommending that the trial stop enrollment and add a 12 month follow-up window to keep the same power.

In the proper sense, all keeping the same power means is that they expect the same number of events. If so, this could be no more that NVCR saw that enrollment was so slow they might as well just wait the 12 months than keep trying to enroll.

In the best sense, the DSMB sees the curves separating so well that they know they have sufficient patients and only need time to collect AEs.

In the worst case, the DSMB just called for a futility halt and NVCR is spinning it. In the cases where a futility halt happens before enrollment is complete. the trial can continue but it is unethical to enroll more patients. An that does match what just happened.


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