Application of estimand framework in ICH E9 (R1) to vaccine trials
Author:
Affiliation:
1. BARDS, MSD, Beijing, USA
2. BARDS, Merck & Co. Inc, Rahway, New Jersey, USA
Funder
no funding associated
Publisher
Informa UK Limited
Subject
Pharmacology (medical),Pharmacology,Statistics and Probability
Link
https://www.tandfonline.com/doi/pdf/10.1080/10543406.2023.2197040
Reference27 articles.
1. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine
2. Principal stratum strategy: Potential role in drug development
3. Chan, I., W. Wang, and J. Heyse. 2018. Clinical trials: Vaccine development from: Encyclopedia of biopharmaceutical statistics CRC press. Accessed December 1, 2021. https://www.routledgehandbooks.com/doi/10.1201/9781351110273-130001226.
4. Efficacy of Recombinant Influenza Vaccine in Adults 50 Years of Age or Older
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1. Guest editors’ note on special issue on application of estimand;Journal of Biopharmaceutical Statistics;2023-04-11
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