http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm446729.pdf
このガイダンスの目次は次の通りです。
1. Introduction and Scope
2. What are Adaptive Designs?
3. When to Choose an Adaptive Design
4. Principles for Adaptation in the Design of Clinical Studies
5. Adaptively-Designed Studies without the Need to Break the Blind
6. Adaptations Using Unblinded Data
7. Special Considerations
8. Additional Considerations for Diagnostic Devices
9. Principles in the Analysis of Data from Adaptive Designs
10. Challenges of Adaptive Studies
11. Regulatory Considerations
12. Conclusion
13. References
医療機器の臨床試験におけるデザインと解析
アダプティブ試験デザインとは
臨床試験におけるアダプティブデザイン
アダプティブ・ランダム化臨床試験
試験結果に基づくアダプティブランダム化法に関する新刊書
[References]
FDA, Adaptive Designs for Medical Device Clinical Studies (July 27, 2016)
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm446729.pdf
[Keywords]
medical device, clinical study, adaptive design, group sequential designs, sample size reassessment, adaptive enrichment, seamless study, bias control