Morris, Tim, Ocampo, Alex, Madsen, Jesper, Roels, Sanne and Hege, Michiels (2026) A Causal Perspective on "Appropriate Implementation of ICH E9(R1) Addendum Strategies" (Comment on Fleming et al.). Statistics in medicine, 45 (6-7). e70455. ISSN 1097-0258

Abstract

This commentary offers perspectives on delivering "rigorous causal inference on meaningful estimands" that differ from the opinions recently shared by Fleming et al. We (1) depict a more robust pathway for achieving this aim that incorporates clinical, causal and statistical reasoning, (2) suggest a tangibility criterion to judge the practical usefulness of an intercurrent event strategy, (3) illustrate the utility of causal inference methods in providing robust estimates when the clinical objective aligns with a hypothetical strategy, and (4) advocate for careful consideration of the tradeoffs between an estimand's relevance and the required assumptions.

Item Type:	Article
Keywords:	causal inference; estimands; intercurrent events; tangibility
Date Deposited:	03 Apr 2026 00:45
Last Modified:	03 Apr 2026 00:45
URI:	https://oak.novartis.com/id/eprint/59675