Principles for Defining Estimands in Clinical Trials-A Proposal.
Pharm Stat
; 2024 Aug 13.
Article
en En
| MEDLINE
| ID: mdl-39138846
ABSTRACT
The ICH E9(R1) guideline outlines the estimand framework, which aligns planning, design, conduct, analysis, and interpretation of a clinical trial. The benefits and value of using this framework in clinical trials have been outlined in the literature, and guidance has been provided on how to choose the estimand and define the estimand attributes. Although progress has been made in the implementation of estimands in clinical trials, to the best of our knowledge, there is no published discussion on the basic principles that estimands in clinical trials should fulfill to be well defined and consistent with the ideas presented in the ICH E9(R1) guideline. Therefore, in this Viewpoint article, we propose four key principles for defining an estimand. These principles form a basis for well-defined treatment effects that reflect the estimand thinking process. We hope that this Viewpoint will complement ICH E9(R1) and stimulate a discussion on which fundamental properties an estimand in a clinical trial should have and that such discussions will eventually lead to an improved clarity and precision for defining estimands in clinical trials.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Idioma:
En
Revista:
Pharm Stat
Asunto de la revista:
FARMACOLOGIA
Año:
2024
Tipo del documento:
Article
País de afiliación:
Suiza
Pais de publicación:
Reino Unido