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Session 0402: STATISTICAL ISSUES IN INTERNATIONAL MULTI-REGIONAL CLINICAL TRIALS
Session Chair(s)
Gang CHEN, PhD
Johnson & Johnson, China
The impact of ethnic factors on efficacy, safety, and dosage of a new treatment has been described in the International Conference on Harmonization (ICH) guideline “Ethnic Factors in the Acceptability of Foreign Clinical Data” (ICH E5, 1998). In New drug development of China, the results from international multi-regional clinical trials (MRCT) alone are often inadequate to assess such impact due to small sample sizes and other statistical concerns. In this session we will discuss those potential statistical issues, the relationship between international MRCT and China registration clinical trials and possible solutions. Panel Discussion: A bull in a china shop - How to spend the fragile Alpha; A holistic view on global vs. local strategies; Adaptive licensing on the MRCT or global development; MRCT: Concept and concerns from statistical perspectives; Why MRCT; Practical consideration from local registration perspectives
Speaker(s)
Jielai Xia, PhD
Air Force Military Medical University, China
Director, Department of Medical Statistics
William Wang, PhD
Merck & Co, Inc, United States
President
Ning Li, MD, PhD
Sanofi, China
Vice President, Head of Asia Regulatory and Medical Policy
Dayao ZHAO, MD, PhD
Pfizer, China
Former Vice President and Lead, China Drug Development
Representative Invited
United States
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