Tuesday, Aug 8: 9:25 AM - 9:50 AM
Invited Paper Session
Metro Toronto Convention Centre
The heterogeneity of treatment effects is challenging and may not be replicated in new trials. There is a simple reason for this: Clinical trials are powered to provide reliable inference on the overall treatment effect. Estimates of subgroup treatment effects will be variable and unreliable in a single trial. As data alone cannot provide definitive answers on subgroup effects, it is important that a workflow around assessing treatment effect heterogeneity should include clinical considerations. A structured approach should be followed to identify variables that modulate the treatment effect and predicting possibly heterogeneous treatment effects on new patients. The workflow includes methodological learnings from the 2022 Analytics Subgroup Challenge at Novartis.