Statistical Methods and Historical Context in Clinical Trials

• Activity Number: 482
• Type: Topic Contributed
• Date/Time: Wednesday, August 12, 2015 : 8:30 AM to 10:20 AM
• Sponsor: Committee on ASA Archives and Historical Materials
• Author(s): William F. Rosenberger*
• Companies: George Mason University
• Keywords: Clinical trials ; History

Abstract

For 75 years, clinical trials have been the primary vehicle for drug development and the establishment of the standard of care in medicine. Statisticians have made substantial contributions to the scientific legitimacy of clinical trials through regulatory guidance, methodological developments, and careful collaboration with physicians. And yet, with few exceptions, statistical reporting of clinical trials has not changed dramatically since their introduction. These few exceptions include the development of sequential monitoring plans, and advances in modelling, particularly of survival and longitudinal data. We review the historical context of statistical methodology in clinical trials and give some pathways for future contributions.