The Contributions of Robert T. O'Neill to the Evolution of Regulatory Statistical Science

• Activity Number: 465
• Type: Invited
• Date/Time: Wednesday, August 7, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Statistics in Biopharmaceutical Research Journal
• Author(s): Charles Anello*+ and Suzanne Junod
• Companies: Applied Statistical Concepts, LLC and US FDA Office of Public Information and Library Servics, FDA History Office
• Keywords: clinical trials ; statistical science ; regulatory

Abstract

Dr. Robert T. O'Neill has been on the forefront of regulatory statistical science since he came to the Food and Drug Administration in 1970. He worked to shape the statistical framework for the drug approval process for all new drugs marketed in the U.S. following passage of the 1962 Kefauver Harris Amendments. This paper will focus on Dr. O'Neill"s responses to challenges in the field of drug development and evaluation and Dr. O'Neill's broad and influential role in the conceptualization and evolution of a systematic, statistically based approach to answering the question "Does this drug really work?" Statisticians working in pharmaceutical science have learned from his pioneering work and sound instincts in a regulatory environment but have also profited from his willingness to communicate through talks, travel, and publications over the years. We will describe some of the statistical principles he articulated so well and consider the role of clinical trial related statistical methodology overall as it has been applied in the biomedical sciences both nationally and internationally. We will conclude with a look at the future of regulatory statistical science.