6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA re­vised and ex­pand­ed a 2019 draft guid­ance that spells out how to ad­just for co­vari­ates in the sta­tis­ti­cal analy­sis of ran­dom­ized con­trolled tri­als.

Build­ing on the ICH’s E9 guide­line on the sta­tis­ti­cal prin­ci­ples for clin­i­cal tri­als, the 3-page draft was trans­formed in­to an 8-page draft, with more de­tailed rec­om­men­da­tions on lin­ear and non­lin­ear mod­els to an­a­lyze the ef­fi­ca­cy end­points in RCTs.

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