KEYNOTE 1: Shaping the Future: Advancing the Value and Protecting the Integrity of Clinical Trials
SPEAKERS: Prof. Scott Evans
MODERATOR: Alfred H. Balch
Abstract:
Clinical trials are our most reliable tool for understanding the benefits and harms of interventions on patients, and provide the most dependable evidence to inform clinical practice. It is a time of great concern for losing the benefits that distinguish clinical trials as the pinnacle of evidence, yet also a time of great opportunity to improve their value. Let us harmonize the unwavering commitment for the foundational scientific principles and objectivity necessary for robust apex evidence, and adopt the spirit of thoughtful carpe diem. Ideas for advancing this vision are discussed. These include placing increased interest on research questions of a pragmatic origin to match their clinical importance, and adjusting our approaches to address these questions.
Instructors’ Biography:
Dr. Scott Evans is a Professor and Founding Chair of the Department of Biostatistics and Bioinformatics and the Director of the Biostatistics Center at Milken Institute School of Public Health of the George Washington University. He is the: Director of the Statistical and Data Management Center for the Antibacterial Resistance Leadership Group (ARLG) funded by NIAID/NIH; the PI of the Coordinating Center for the Exercise and Nutrition Interventions to Improve Cancer Treatment-Related Outcomes (ENICTO) in Cancer Survivors Consortium funded by the NCI/NIH, and the co-PI of the Data Coordinating Center of the Clamp OR Delay among neonates with Congenital Heart Disease (CORD-CHD) clinical trial funded by the NHLBI/NIH. He is the author of more than 250 publications and four books on clinical trials. He served as: the Guest Editor of a mini-Series on DSMBs for the NEJM Evidence; a member of an FDA Advisory Committee; and the past-President of the Society for Clinical Trials (SCT). He is a recipient of the Mosteller Statistician Award, the Zackin Distinguished Collaborative Statistician Award, the Founders Award from the American Statistical Association (ASA), an elected member of the International Statistical Institute (ISI), and is a Fellow of the ASA, SCT, and the Infectious Disease Society of America (IDSA).