How to implement the ‘one patient, one vote’ principle under the framework of estimand-Reference-Cited by-同舟云学术

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How to implement the ‘one patient, one vote’ principle under the framework of estimand

Published:2023-04-15 Issue:3 Volume:7 Page:202-212
ISSN:2475-4269
Container-title:Statistical Theory and Related Fields
language:en
Short-container-title:Statistical Theory and Related Fields

Author:

Ting Naitee¹

Affiliation:

1. Department of Biostatistics and Data Sciences, Boehringer Ingelheim Pharmaceuticals, Inc, Danbury, CT, USA

Publisher

Informa UK Limited

Subject

Applied Mathematics,Computational Theory and Mathematics,Statistics, Probability and Uncertainty,Statistics and Probability,Analysis

Link

https://www.tandfonline.com/doi/pdf/10.1080/24754269.2023.2164943

Reference10 articles.

1. EMA (2011). Guideline on missing data in confirmatory clinical trials. European Medicine Agency. Retrieved from https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-missing-data-confirmatory-clinical-trialsen.pdf

2. ICH E9 (1998). Statistical principles for clinical trials. Retrieved from https://database.ich.org/sites/default/files/E9Guideline.pdf

3. ICH E9 (R1) (2019). Addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials. Retrieved from https://database.ich.org/sites/default/files/E9-R1S/tep4Guideline20191203.pdf16

4. Recommendations for the Primary Analysis of Continuous Endpoints in Longitudinal Clinical Trials

5. Multiple Imputation after 18+ Years

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