Open problems in intercurrent-event handling and missing-data mechanisms in randomised clinical trials

Abstract

A simulation-based assessment of the regulatory toolkit for intercurrent-event handling and missing-data mechanisms in randomised clinical trials, tracing the arc from single imputation to estimands and stress-testing current methods against the questions they are meant to answer.

Kiss Márton MD

Clinical Research Specialist, Applied Biostatistician

Well-versed in pharmacovigilance, scientific consulting, as well as clinical trials, with an emphasis on PK and BE studies.