Estimand framework: Are we asking the right questions? A case study in the solid tumor setting-Reference-Cited by-同舟云学术

Estimand framework: Are we asking the right questions? A case study in the solid tumor setting

Published:2020-11-05 Issue:2 Volume:20 Page:324-334
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Casey Michelle¹,Degtyarev Evgeny²,Lechuga María José³,Aimone Paola²,Ravaud Alain⁴,Motzer Robert J.⁵,Liu Feng⁶,Stalbovskaya Viktoriya⁷,Tang Rui⁸,Butler Emily⁹,Sailer Oliver¹⁰,Halabi Susan¹¹^ORCID,George Daniel¹²

Affiliation:

1. Pfizer, Inc. Collegeville Pennsylvania USA

2. Novartis Pharma AG Basel Switzerland

3. Pfizer Srl Milan Italy

4. Bordeaux University Hospital Bordeaux France

5. Memorial Sloan Kettering Cancer Center New York New York USA

6. AstraZeneca Gaithersburg Maryland USA

7. Merus NV Utrecht The Netherlands

8. Servier Pharmaceuticals Boston Massachusetts USA

9. GlaxoSmithKline Collegeville Pennsylvania USA

10. Boehringer Ingelheim Pharma GmbH & Co Biberach Germany

11. Duke University Durham North Carolina USA

12. Duke Cancer Center Durham North Carolina USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.2079

Reference21 articles.

1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals For Human Use.ICH Harmonised Guideline. Addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials E9(R1).2017.https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf[accessed: 9 January 2020].

2. Treatment effect quantification for time‐to‐event endpoints–Estimands, analysis strategies, and beyond

3. Seeking harmony: estimands and sensitivity analyses for confirmatory clinical trials

4. Estimands in clinical trials - broadening the perspective

5. Estimands: A More Strategic Approach to Study Design and Analysis

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