"He's wrong in one area but I am sure he will still claim he is right somehow ... but hey what would I know ? "
Not much going from your recent form both here and there.
Reviews are different depending on the type, stage, likely risk and size/duration of trials. but surely with all your experience at M, you knew this right
"When is a DSMB most likely to be convened?
Although there is no single rule for what types of study require a DSMB, the are used most commonly in later phase (IIb to IV7 ) trials that address major health outcomes such as mortality or
progression of a serious disease and that are designed to definitively address efficacy and safety
issues [2]. They may also be convened when there is a significant risk of harm, or unknown or
uncertain risks, so that regular interim, comparative analyses of the accumulating safety and efficacy
data can be performed. DSMBs are therefore most likely to be used in trials where unblinded interim
data analysis is necessary to ensure the safety of research participants."
Perhaps you can school yourself here: https://www.australianclinicaltrials.gov.au/sites/default/files/content/For%20researchers/Data%20Safety%20Monitoring%20Boards_1.pdf
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