A nested group sequential framework for regional evaluation in global drug development program
Author:
Affiliation:
1. Biostatistics and Research Decision Science, Merck Research Laboratory, Merck & Co., Inc., Beijing, China
2. Department of Health Statistics, School of Preventive Medicine, Fourth Military Medical University, Xi’an, Shaanxi, China
Funder
National Science Foundation of China
Publisher
Informa UK Limited
Subject
Pharmacology (medical),Pharmacology,Statistics and Probability
Link
https://www.tandfonline.com/doi/pdf/10.1080/10543406.2017.1293079
Reference30 articles.
1. Decision Rules and Associated Sample Size Planning for Regional Approval Utilizing Multiregional Clinical Trials
2. Assessing consistent treatment effect in a multi-regional clinical trial: a systematic review
3. An adaptive strategy for assessing regional consistency in multiregional clinical trials
4. Graphical assessment of consistency in treatment effect among countries in multi-regional clinical trials
5. ASSESSING SENSITIVITY AND SIMILARITY IN BRIDGING STUDIES
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