Principal stratum strategy: Potential role in drug development-Reference-Cited by-同舟云学术

Principal stratum strategy: Potential role in drug development

Published:2021-02-23 Issue:4 Volume:20 Page:737-751
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Bornkamp Björn¹^ORCID,Rufibach Kaspar²^ORCID,Lin Jianchang³,Liu Yi⁴,Mehrotra Devan V.⁵^ORCID,Roychoudhury Satrajit⁶^ORCID,Schmidli Heinz¹,Shentu Yue⁷,Wolbers Marcel²

Affiliation:

1. Clinical Development and Analytics Novartis Basel Switzerland

2. Methods, Collaboration, and Outreach Group (MCO), Department of Biostatistics Hoffmann‐La Roche Ltd Basel Switzerland

3. Statistical & Quantitative Sciences (SQS) Takeda Pharmaceuticals Cambridge Massachusetts USA

4. Nektar Therapeutics San Francisco California USA

5. Clinical Biostatistics Merck & Co., Inc. North Wales Pennsylvania USA

6. Pfizer Inc. New York New York USA

7. Merck & Co., Inc. Rahway New Jersey USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.2104

Reference77 articles.

1. International Council of Harmonization.Addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials E9(R1);2019.https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf

2. Principal Stratification in Causal Inference

3. Cautions as Regulators Move to End Exclusive Reliance on Intention to Treat

4. A constructive critique of thedraftICH E9 Addendum

5. Principal Stratification -- a Goal or a Tool?

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