Possible data-generating models of longitudinal continuous outcomes and intercurrent events to investigate estimands-Reference-Cited by-同舟云学术

Possible data-generating models of longitudinal continuous outcomes and intercurrent events to investigate estimands

Published:2024-06-26 Issue: Volume: Page:1-25
ISSN:1946-6315
Container-title:Statistics in Biopharmaceutical Research
language:en
Short-container-title:Statistics in Biopharmaceutical Research

Author:

Mitroiu Marian¹²^ORCID,Teerenstra Steven¹³,Oude Rengerink Katrien¹²,Pétavy Frank⁴,Roes Kit CB¹³

Affiliation:

1. Methodology Working Group, Medicines Evaluation Board, The Netherlands

2. Clinical Trial Methodology Department, Biostatistics and Research Support, Julius Center for Health Sciences and Primary Care, Biostatistics and Research Support, University Medical Center Utrecht, Utrecht University, The Netherlands

3. Department for Health Evidence, section Biostatistics, Radboud University Medical Center, The Netherlands

4. Data Analytics and Methods Taskforce, European Medicines Agency, The Netherlands

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/19466315.2024.2369266

Reference35 articles.

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2. ICH Official web site : ICH [Internet]. [cited 2021 May 17]. Available from: https://www.ich.org/page/efficacy-guidelines

3. U.S. Food and Drug Administration [Internet]. 2021 [cited 2021 May 17]. E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e9r1-statistical-principles-clinical-trials-addendum-estimands-and-sensitivity-analysis-clinical

4. ICH E9(R1) EWG. ICH E9(R1) Estimands and Sensitivity Analysis in Clinical Trials. STEP 4 TECHNICAL DOCUMENT. [Internet]. [cited 2019 Dec 4]. Available from: https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf

5. Lasch F Guizzaro L Dávila LA Müller‐Vahl K Koch A. Potential impact of COVID-19 on ongoing clinical trials: a simulation study with the neurological Yale Global Tic Severity Scale based on the CANNA-TICS study. Pharmaceutical Statistics [Internet]. [cited 2021 Mar 10];n/a(n/a). Available from: https://onlinelibrary.wiley.com/doi/abs/10.1002/pst.2100