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Unified Additional Requirement in Consideration of Regional Approval for Multiregional Clinical Trial

Time

Mon, Jun 16 7:45AM
M 12

Title

Unified Additional Requirement in Consideration of Regional Approval for Multiregional Clinical Trial

Abstract Summary

After reviewing the multiregional clinical trials conducted in the past 5 years based on literature search, the authors have proposed and examined a unified additional requirement for regional approval based on hypothesis test using a well defined assurance probability.

Poster Presenter

Zhaoyang Teng
MA,
PhD Candidate, Biostatistics,
Boston University
United States