Biostatistics Forum

GBC 10

Biostatistics Forum

09:00 ~ 18:00 GB I 5F

Summary
The safety and efficacy of medicines are approved by clinical tests. Therefore, the role of statistics is essential for the plans and analysis of clinical tests. The considerations of the latest international analytics and statistics for designing clinical tests will be discussed.
Date
June 29(Fri), 09:00 ~ 18:00
Venue
GB I 5F Venue Guide

Schedule

Time Title Presentation File
Biostatistics
[Session 1] Recent trend in Adaptive design and Safety evaluation | Chair : Seung-Ho Kang (Yonsei University)
09:00~09:40(40')

Confirmatory Adaptive Clinical Trial Designs

Martin Posch / Univ of Vienna

09:40~10:20(40')

Recent Advances in Medical Product Safety Evaluation

Jie Chen / Merck

10:20~10:40(20')

Coffee Break

-
[Session 2] CDISC for Clinical Trials | Chair : Seung-Ho Kang (Yonsei University)
10:40~11:20(40')

Effective Use of Clinical Data Standards in the Real World

David Bobbitt / CDISC

11:20~12:00(40')

Application of CDISC ADaM in Biostatistics

ByeongKwan Park / LSK, Korea

[Session 3] Statistical Considerations in Designing Clinical Trials | Chair : Byung-Ho Nam (HERINGS)
13:30~14:10(40')

Dose-selection trial designs

Chul Ahn / UT Southwestern Medical Center

14:10~14:50(40')

Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials

Toshiro Tango / CMS

-
14:50~15:30(40')

Introduction to design of multi-regional clinical trials (MRCTs) and statistical models for MRCTs

Hsiao-Hui Tsou / National Health Research Institutes

-
15:30~16:00(30')

Coffee Break

-
[Session 4] International Guidelines and Trends in Drug Regulatory Authorities | Chair : Yun Chon (Int'l Vaccine Institute)
16:00~16:40(40')

How the ICH E9 addendum around estimands may impact our clinical trials

Frank Bretz / Novartis

16:40~17:20(40')

Statistical Considerations in NDA Review Incorporating Bridging Issues

Mey Wang / CDE