The estimands framework: a primer on the ICH E9(R1) addendum
MRC Clinical Trials Unit at UCL · University College London · +4 more institutions
Abstract
Estimands can be used in studies of healthcare interventions to clarify the interpretation of treatment effects. The addendum to the ICH E9 harmonised guideline on statistical principles for clinical trials (ICH E9(R1)) describes a framework for using estimands as part of a study. This paper provides an overview of the estimands framework, as outlined in the addendum, with the aim of explaining why estimands are beneficial; clarifying the terminology being used; and providing practical guidance on using estimands to decide the appropriate study design, data collection, and estimation methods. This article illustrates how to use the estimands framework by applying it to an ongoing trial in emergency bowel…
Citation impact
- FWCI
- 137.69
- Percentile
- 100%
- References
- 64
Authors
5- BCBrennan C KahanCorresponding
MRC Clinical Trials Unit at UCL, University College London
- JHJoanna Hindley
MRC Clinical Trials Unit at UCL, University College London
- MEMark Edwards
University Hospital Southampton NHS Foundation Trust, NIHR Southampton Biomedical Research Centre, University of Southampton
- SCSuzie Cro
Imperial College London
- TPTim P. Morris
MRC Clinical Trials Unit at UCL, University College London
Topics & keywords
- Addendum
- Terminology
- Computer science
- Management science
- Data science