Application of estimand framework to the design and analysis of multi-regional clinical trials
Author:
Affiliation:
1. BARDS, MSD R&D (China) Co. Ltd, Beijing, China
2. BARDS, MSD China, Shanghai, China
3. BARDS, Merck & Co., Inc., Rahway, New Jersey, USA
Funder
there is no funding associated with the work
Publisher
Informa UK Limited
Link
https://www.tandfonline.com/doi/pdf/10.1080/10543406.2024.2362736
Reference32 articles.
1. Practical issues and lessons learned from multi-regional clinical trials via case examples: a Japanese perspective
2. Points to Consider for Implementation of the ICH E17 Guideline: Learning from Past Multiregional Clinical Trials in Japan
3. Regulatory Challenges in the Review of Data from Global Clinical Trials: The PMDA Perspective
4. Assessing consistent treatment effect in a multi-regional clinical trial: a systematic review
5. Trial design issues and treatment effect modeling in multi-regional schizophrenia trials
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