Toshimitsu Hamasaki is a Professor at the George Washington University (GWU) Biostatistics Center and the Department of Biostatistics and Bioinformatics. Prior to joining GWU, he worked at Shiogoni, Pfizer, Osaka University and the National Cerebral and Cardiovascular Center. His research interests include the design, monitoring, analyses, and reporting of clinical trials. He was a co-chair of the Society for Clinical Trials (SCT) Program Committee and the chair of the ASA Committee on International Relations in Statistics. He was a member of the Steering Committee for the Adaptive Designs CONSORT Extension (ACE) Project, an extension to the Consolidated Standards of Reporting Trials (CONSORT) Statement for adaptive clinical trials, and a member of the ICH-E5 Guideline Implementation Working Group as a representative of Japan Pharmaceutical Manufacturers Association. He is an elected member of the International Statistical Institute (ISI) and a fellow of the ASA. He received the Distinguished Article Award from the Japanese Society of Computational Statistics and the Hida-Mizuno Prize from the Behaviormetric Society of Japan.