Estimands and Their Role in Clinical Trials-Reference-Cited by-同舟云学术

Estimands and Their Role in Clinical Trials

Published:2017-07-03 Issue:3 Volume:9 Page:268-271
ISSN:1946-6315
Container-title:Statistics in Biopharmaceutical Research
language:en
Short-container-title:Statistics in Biopharmaceutical Research

Author:

Akacha Mouna¹,Bretz Frank¹²,Ohlssen David³,Rosenkranz Gerd²,Schmidli Heinz¹

Affiliation:

1. Novartis Pharma AG, Statistical Methodology and Consulting, Basel, Switzerland

2. Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Wien, Austria

3. Novartis Pharmaceuticals Corporation, Statistical Methodology and Consulting, East Hanover, NJ

Publisher

Informa UK Limited

Subject

Pharmaceutical Science,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/19466315.2017.1302358

Reference20 articles.

1. Estimands in clinical trials - broadening the perspective

2. FDA (2011), “Briefing Document,” available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM262994.pdf

3. Choice of estimand and analysis methods in diabetes trials with rescue medication

4. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (1998), “ICH Harmonised Tripartite Guideline E9: Statistical Principles for Clinical Trials,” available at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step-4/E9_Guideline.pdf

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