Estimands in clinical trials–broadening the perspective

M Akacha, F Bretz, S Ruberg - Statistics in medicine, 2017 - Wiley Online Library
… stakeholders, they all have similar interests in what the clinical trial estimands should be.
Broadly, these can be classified into estimands addressing (a) lack of adherence to treatment …

Choosing appropriate estimands in clinical trials

AK Leuchs, J Zinserling, A Brandt… - Therapeutic …, 2015 - journals.sagepub.com
… effects in clinical trial practice is essential, and estimands 1,2 … Nevertheless, the distinction
of different estimands is not … clinical trial data, some observations needed for an estimand are …

Choosing estimands in clinical trials: putting the ICH E9 (R1) into practice

B Ratitch, J Bell, C Mallinckrodt, JW Bartlett… - … innovation & regulatory …, 2020 - Springer
… paper consider estimands in the context of randomized clinical trials, the estimand concept
Estimands are naturally incorporated within the framework of causal inference, for example, …

Causal inference and estimands in clinical trials

I Lipkovich, B Ratitch… - Statistics in …, 2020 - Taylor & Francis
… causal inference in observational and clinical trials, and to capitalize on those … estimands
and addressing ICEs in the clinical trials context. Using the PO framework to define estimands

Choosing estimands in clinical trials with missing data

C Mallinckrodt, G Molenberghs… - Pharmaceutical …, 2017 - Wiley Online Library
… to examine considerations for choosing estimands using three focus estimands. These three
are not the only estimands of interest in clinical trials. For example, an estimand noted in the …

Estimands and their role in clinical trials

M Akacha, F Bretz, D Ohlssen… - Statistics in …, 2017 - Taylor & Francis
clinical trial in patients with Type 2 diabetes mellitus. In Section 4, we conclude this article
with a short discussion about the potential impact on statisticians involved in clinical trial

Incorporating estimands into clinical trial statistical analysis plans

M Kang, MA Kendall, H Ribaudo, C Tierney… - Clinical …, 2022 - journals.sagepub.com
… principles of statistical methodology in clinical trials. Addendum E9 (R1) … estimands and
sensitivity analyses. Since the release of E9 (R1), clinical trial protocols have included estimands

Defining efficacy estimands in clinical trials: examples illustrating ICH E9 (R1) guidelines

B Ratitch, N Goel, C Mallinckrodt, J Bell… - … Innovation & Regulatory …, 2020 - Springer
… This paper provides detailed examples of estimand definitions in several clinical trial … R1)
draft addendum on “Estimands and Sensitivity Analysis in Clinical Trials.”This paper follows the …

[图书][B] Estimands, estimators and sensitivity analysis in clinical trials

C Mallinckrodt, G Molenberghs, I Lipkovich, B Ratitch - 2019 - taylorfrancis.com
… try to estimate from clinical trial data and how we can estimate those quantities. This book
provides details on how clear estimands lay a foundation for specifying aspects of trial design, …

Estimands, estimators, and estimates

RJ Little, RJ Lewis - JAMA, 2021 - jamanetwork.com
… and because there are practical limitations in clinical trial execution, such as participants’ not
estimand, is a formula or algorithm used to estimate the target quantity from the clinical trial