Regional consistency assessment in multiregional clinical trials
Author:
Affiliation:
1. Global Medical Affairs, Eisai, Inc, Nutley, New Jersey, USA
2. Biostatistics & Programming, Sanofi, Bridgewater, New Jersey, USA
3. Statistical Programming, Janssen Research & Development, Raritan, New Jersey, USA
Funder
no funding associated with the work featured in this article
Publisher
Informa UK Limited
Link
https://www.tandfonline.com/doi/pdf/10.1080/10543406.2024.2330214
Reference20 articles.
1. Assessing consistent treatment effect in a multi-regional clinical trial: a systematic review
2. Consistency of Treatment Effect across Regions in Multiregional Clinical Trials, Part 1: Design Considerations
3. Graphical assessment of consistency in treatment effect among countries in multi-regional clinical trials
4. European Medicines Agency. 2009 February. Reflection paper on the extrapolation of results from clinical studies conducted outside Europe to the EU-population (draft). EMEA Doc. Ref. CHMP/EWP/692702/2008. http://www.emea.europa.eu/pdfs/human/ewp/69270208en.pdf.
5. FDA Medical review of COZAARTM tablets (losartan potassium). NDA 20-386/SE1-028 March 2002. Last accessed on June 30 at https://wayback.archive-it.org/7993/20170404085116/https://www.fda.gov/ohrms/dockets/ac/02/briefing/3849b1.htm
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