Links to major regulatory information of Biostatistics.
Regulations and Notifications
Clinical Trial Design
- Points to consider for externally controlled trials (Early Consideration)[96.77KB]
March 24, 2025 Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency
- Statistical Considerations When Planning Phase I Clinical Trials in Oncology - From the Safety Perspective (Early consideration) [197KB]
December 4, 2024 Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency
Master Protocol
- Considerations for the Utilization of Master Protocol Trials in Drug Development[303KB]
June 20, 2024 Administrative Notice
Data Monitoring
- Guideline on Data Monitoring Committee[198.41KB]
April 4, 2013 PFSB/ELD Notification No. 0404-1