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Lots of colleagues & friends remain sore after the #FauciLeak on the interim #ACTT trial analysis that compared #remdesivir to placebo in patients hospitalized with severe #COVID19 2 days ago.

My thoughts on the events as a #clinicaltrials and #DSMB doctor—thread 1/10
Data Safety Monitoring Boards (#DSMB) are independent groups of doctors & statisticians that analyze unblinded data in clinical trials, key to assure safety of patients enrolled, think about it as a safety satellite or control tower for the blinded investigators & patients.
#DSMBs have an instruction set (charter) agreed on before the #trial starts, includes prespecified statistical analyses (very low p-values) and thresholds that would trigger stopping a trial early for efficacy (big beneficial effect), toxicity (harms), futility (wasting our time)
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