Global Clinical Trials: Challenges, Risks and Rewards

Time

Tue, Jun 25 11:45AM
T 05

Title

Global Clinical Trials: Challenges, Risks and Rewards

Abstract Summary

Literature reviews of statistical design strategies relevant to MRCT are performed. We focus on a drug development scenario where the MRCT is based on a common protocol but early filing in certain regions (e.g. US and EU) is desired while the trial continues to enroll in China, for example. The goal is to ensure validity in trial results to enable both the regional approval in China and approvals in the US and EU. Different approaches are discussed and outcomes are compared.

Poster Presenter

Ai Li
Biostatistics Manager ,
Amgen
United States

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