Open AccessIncorporating estimands into clinical trial statistical analysis plans
Author(s) -
Minhee Kang,
Michelle A. Kendall,
Heather J. Ribaudo,
Camlin Tierney,
Zheng Li,
Laura Smeaton,
Jane C. Lindsey
Publication year - 2022
Publication title -
clinical trials
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.559
H-Index - 63
eISSN - 1740-7753
pISSN - 1740-7745
DOI - 10.1177/17407745221080463
Subject(s) - clinical trial , medicine , statistics , computer science , econometrics , mathematics
International Council for Harmonisation (ICH) E9 Statistical Principles for Clinical Trials was developed as a consensus guidance document to encourage worldwide harmonization of the principles of statistical methodology in clinical trials. Addendum E9 (R1) clarified and extended ICH E9 with a focus on estimands and sensitivity analyses. Since the release of E9 (R1), clinical trial protocols have included estimands, but there is variation in how they are presented. Statistical analysis plans (SAPs) are increasingly becoming publicly available (e.g. posting on ClinicalTrials.gov) and present an opportunity to link estimands with planned analyses to present the alignment of trial objectives, design, conduct, and analysis.