Author:
Quan Hui,Mao Xuezhou,Wang Jun,Zhang Ji
Publisher
Springer International Publishing
Reference25 articles.
1. Chen J, Quan H, Binkowitz B, Ouyang SP, Tanaka Y, Li G, Menjoge S, Ibia E (2010) Assessing consistent treatment effect in a multi-regional clinical trial: a systematic review. Pharm Stat 9:242–253
2. Chen J, Quan H, Gallo P, Ouyang SP, Binkowitz B (2012) An adaptive strategy for assessing regional consistency in multiregional clinical trials. Clin Trials 9:330–339
3. European Medicines Agency (2008) 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. Available at https://www.ema.europa.eu/documents/scientific-guideline/reflection-paper-extrapolation-results-clinical-studies-conducted-outside-european-union-eu-eu_en.pdf . Accessed 12 Feb 2019
4. Fedorov V, Jones B (2005) The design of multicentre trials. Stat Methods Med Res 14:205–248
5. Girman CJ, Ibia E, Menjoge S, Mak C, Chen J, Agarwal A, Binkowitz B (2011) Impact of different regulatory requirements for trial endpoints in multiregional clinical trials. Drug Inf J 45:587–594