Evaluation of local treatment effect by borrowing information from similar countries in multi-regional clinical trials
Author:
Affiliation:
1. Department of Statistics Sciences; Allergan Inc.; Jersey City NJ 07311 U.S.A.
2. Biostatistics; Sanofi Pasteur; Swiftwater PA 18370 U.S.A.
3. Biostatistics and Programming; Sanofi; Bridgewater NJ 08807 U.S.A.
Publisher
Wiley
Subject
Statistics and Probability,Epidemiology
Link
http://onlinelibrary.wiley.com/wol1/doi/10.1002/sim.6815/fullpdf
Reference19 articles.
1. Ethnic factor in the acceptability of foreign data;ICH International Conference on Harmonization Tripartite Guidance E5;The US Federal Register,1998
2. Consideration of regional difference in design and analysis of multi-regional trials;Hung;Pharmaceutical Statistics,2010
3. Assessing consistent treatment effect in a multi-regional clinical trial: a systematic review;Chen;Pharmaceutical Statistics,2010
4. Assessment of consistency of treatment effects in multiregional clinical trials;Quan;Drug Information Journal,2010
5. Consistency of treatment effect across regions in multiregional clinical trials, Part 1: design considerations;Chen;Drug Information Journal,2011
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