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Re: north40000 post# 412968

Monday, 07/24/2023 5:33:59 PM

Monday, July 24, 2023 5:33:59 PM

Post# of 427051
The thing that gets me is that the DSMB and IRB are very different groups.

Here's the MITIGATE DSMB:
Data and Safety Monitoring Board:
Edward J. McNulty, MD (Medical Director, Regional Cardiac Services)
Catherine Lee, PhD (Senior Biostatistician)
Douglas A. Corley, MD, PhD (DSMB Chair)

But the Kaiser IRB (Institutional Review Board) is coalition of both scientists and non-scientists apparently. Their purview is more oriented towards ethics and compliance, and they don't have unblinded access to the trial data without a report from the DSMB.

https://www.kpwashingtonresearch.org/get-involved/institutional-review-board
https://irb.kp-scalresearch.org/kpirb.html

If the DSMB recommended a stop to the trial, either due to futility or established efficacy, I just don't see a need for an IRB suspension.
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