TITLE: Medical Product Safety Evaluation: Biological Models & Statistical Methods
INSTRUCTORS: Dr. Jie Chen, Merck Research Laboratories
MODERATOR: Naitee Ting
This two-day short course is based on the book with the same name, published by CRC in 2015. It provides an overview of the fundamental concepts for statisticians and non-statisticians in clinical trials. The course is designed for professionals relatively new to the pharmaceutical, biotechnology, or device industries; government agencies (e.g., FDA, NIH, and CDC); academia; or research institutes engaging in clinical trials. Topics include: the role of the clinical trial statistician, clinical development plans, clinical trial design issues (e.g., randomization, blinding, control groups, composite and surrogate endpoints, noninferiority, the protocol document), statistical analysis plans, data monitoring committees, analysis issues (subgroup analyses, benefit-to-risk evaluation), CONSORT, and study report preparations.
The two instructors are Dr. Naitee Ting from Beohringer-Ingelheim Pharmaceuticals, Inc. and Dr. Scott Evans from George Washington University. They have more than 50 years of combined experience in clinical trials. They also have diverse and complementary backgrounds. Dr. Ting is from the pharmaceutical industry and taught clinical trials at the University of Connecticut and Columbia University. Dr. Evans is from academia, has taught clinical trials more than a dozen times, and has taught short courses on topics in clinical trials at JSM, SCT, the FDA, the Deming Conference, the FDA-Industry Statistics Workshop, and the Graybill Conference. They have taught a similar course as co-instructors at PERI and BASS.
Dr. Scott Evans is a tenured Professor of Epidemiology and Biostatistics and the Director of the George Washington Biostatistics Center. Professor Evans interests include the design, monitoring, analyses, and reporting of and education in clinical trials and diagnostic studies. He is the author of more than 100 peer-reviewed publications and three textbooks on clinical trials including Fundamentals for New Clinical Trialists. He is the Director of the Statistical and Data Management Center (SDMC) for the Antibacterial Resistance Leadership Group (ARLG), a collaborative clinical research network that prioritizes, designs, and executes clinical research to reduce the public health threat of antibacterial resistance. Professor Evans is a member of the Board of Directors for the American Statistical Association (ASA) and the Society for Clinical Trials (SCT) and is a former member of the Board for the Mu Sigma Rho (the National Honorary Society for Statistics). He is a member of an FDA Advisory Committee, the Steering Committee of the Clinical Trials Transformation Initiative (CTTI), and serves as the Chair of the Trial of the Year Committee of the SCT. Professor Evans is the Editor-in-Chief of CHANCE and Statistical Communications in Infectious Diseases (SCID), and the Co-Editor of a Special Section of Clinical Infectious Diseases (CID) entitled Innovations in Design, Education, and Analysis (IDEA). Professor Evans has served on numerous DSMBs for government and industry-sponsored clinical trials including as Chair of the DSMBs for the Adolescent Trials Network (ATN). Dr. Evans is a recipient of the Mosteller Statistician of the Year Award, the Robert Zackin Distinguished Collaborative Statistician Award, and is a Fellow of the ASA and the SCT.