RL15 Multiregional Trials
*Yoko Adachi, U.S. Food and Drug Administration 


As more clinical trials are conducted in regions other than the United States and Western Europe, various issues emerge for statisticians. The discussion will focus on opportunities and challenges that biostatisticians face when a drug is developed and marketed in many countries, such as regulatory differences, cultural barriers communication issues, and experimental design issues created by enrolling multiple sites from multiple regions.