Drug development has rapidly been globalized. Multi-regional clinical trial (MRCT) for regulatory submission has widely been conducted in the ICH and non-ICH regions. Regulatory agencies currently face challenges in evaluating data from MRCTs for drug approval. In order to harmonize points to consider in planning/designing MRCTs and minimize conflicting opinions, an ICH working group was established in late 2014 to create an international guideline for MRCT (ICH E17). In June 2016, a draft guidance entitled ''E17 General Principles for Planning and Design of Multi-Regional Clinical Trials'' was issued by the ICH for public comment. This tutorial session contains 4 parts: (1) review evolving regulatory landscape and background about the ICH E17; (2) discuss key principles outlined in the draft ICH E17 (Step 2b); (3) key statistical considerations in designing MRCTs; and (4) learn the relevant concepts using case studies of multi-regional clinical trials in Japan. We welcome interactive questions and discussions.
Dr. William (Bill) Wang is an executive director, clinical safety statistics, in the department of Biostatistics and Research Decision Sciences (BARDS), Merck Research Laboratories. He has over 20 years of experience in the pharmaceutical industry, with expertise and research publications in statistical design, analysis, clinical data management and their technology enablement. During his 15-year tenure at Merck, he supported regulatory filings in multiple therapeutic areas and established the BARDS Asia Pacific operation. Since 2010, he has served on the DIA China Regional Advisory Board and the DIAís Global Community Leadership Council (CLC), including the chairmanship of the DIA China Statistics Community. He was a recipient of the DIA global inspire award award in 2012. He is currently chairing an ASA safety monitoring working group, and a deputy topics-leader in the ICH E17 working group on multi-regional clinical trials.
Dr. Bruce Binkowitz is Vice President of Biometrics at Shionogi Incorporated, leading the Statistics, Statistical Programming and Data Management groups. He has more than 30 years of experience in the pharmaceutical industry.
Prior to joining Shionogi, Dr. Binkowitz spent a long and successful career at Merck and Co. He is a recognized thought leader in the area of multi-regional clinical trials, and co-chairs the Society of Clinical Trials MRCT Consistency Expert Group, a group about to approach its 10 year in researching MRCTs. Bruce is active in the statistical community, including the ASA Biopharmaceutical section, the DIA Statistics Community, the ENAR Regional Board of Advisors, and the Council for Biopharmaceutical Statistics. He has served as chair for DIA workshops, the Statistics Track for the DIA North America Annual Meeting, and the ASA Biopharmaceutical Section FDA/Industry Statistics Workshop. Bruce has many publications in a variety of Statistical and Clinical journals and has given presentations at all the major Statistical conferences and workshops and is a Fellow of the American Statistical Association.
Dr. Yuki Ando is a Senior Scientist for Biostatistics of the Pharmaceuticals and Medical Devices Agency (PMDA), Japan.
She received a masterís degree in Engineering from Tokyo Science University, and PhD in Health Science from Osaka University.
In 1997, she joined the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC), which was established that year and subsequently transformed into the current PMDA. Currently she is responsible for the biostatistics review and consultation in the new drug and device review offices in PMDA. Additionally, she works as a leader of business part of Advanced Review with Electronic Data Promotion Group, the group which is responsible for the use of patient level electronic study data that are submitted with new drug applications in Japan. She is responsible for promoting CDISC implementation and the use of submitted electronic data in new drug review in PMDA.