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A Case Study of Statistical Borrowing in a Regulatory Setting

Presented During: PS31: Case Studies of Statistical Borrowing in Clinical Trials: From Design to Regulatory Approval

Conference: ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop 2025

09/26/2025: 8:30 AM EDT - 9:45 AM EDT
Parallel

Description

This talk presents a second case study of statistical borrowing in a regulatory setting, focusing on the statistical approach to borrowing, regulatory interactions, and the impact of borrowing on the final trial results.

Presenting Author

Inna Perevozskaya, BMS