Assessing efficacy in important subgroups in confirmatory trials: An example using Bayesian dynamic borrowing-Reference-Cited by-同舟云学术

Assessing efficacy in important subgroups in confirmatory trials: An example using Bayesian dynamic borrowing

Published:2021-01-21 Issue:3 Volume:20 Page:551-562
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Best Nicky¹^ORCID,Price Robert G.²^ORCID,Pouliquen Isabelle J.¹^ORCID,Keene Oliver N.¹^ORCID

Affiliation:

1. Department of Biostatistics GlaxoSmithKline Research and Development Brentford UK

2. Department of Clinical Pharmacology Modelling & Simulation GlaxoSmithKline Research and Development Stevenage Herts UK

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.2093

Reference26 articles.

1. FDA.Integrated summary of effectiveness guidance for industry;2015.https://www.fda.gov/downloads/drugs/guidances/ucm079803.pdf(accessed March 2019).

2. International Conference on Harmonisation (ICH).E17: General principles for planning and design of multi‐regional clinical trials;2017.https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E17/E17EWG_Step4_2017_1116.pdf(accessed March 2019).

3. Subgroups: Time to Go Back to Basic Statistical Principles?

4. EMA.Reflection paper on extrapolation of efficacy and safety in paediatric medicine development;2016.http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2016/04/WC500204187.pdf(accessed April 2019).

5. Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned

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