Process guide for inferential studies using healthcare data from routine clinical practice to evaluate causal effects of drugs (PRINCIPLED): considerations from the FDA Sentinel Innovation Center.
Rishi J DesaiShirley V WangSushama Kattinakere SreedharaLuke ZabotkaFarzin Khosrow-KhavarJennifer C NelsonXu ShiSengwee TohRichard WyssElisabetta PatornoSarah DutcherJie LiHana LeeRobert BallGerald Dal PanJodi B SegalSamy SuissaKenneth J RothmanSander GreenlandMiguel A HernánPatrick J HeagertySebastian SchneeweissPublished in: BMJ (Clinical research ed.) (2024)