Recorded presentation

Robert T. O'Neill, PhD, Office of Biostatistics, U. S. Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane - Rm 15B-45, Rockville, MD 20857-0001, (301) 827-3195, oneill@cder.fda.gov

Dr. Robert T. O'Neill has been selected to be the 2004 APHA Statistics Section Lowell Reed Lecturer. Each year the Statistics Section selects an outstanding statistician who has contributed to the field of statistics and public health through significant contributions in research, teaching and service. The award is given in memory of Dr. Lowell Reed who is most noted for his discovery of the ED-50, a tool for toxicology, and for his work on the Reed Frost epidemic model. The awardee is selected to give the Keynote Address during the Lowell Reed Lecture, Spiegelman and Statistics Section Awards Session. This year the Statistics Section is proud to honor Dr. Robert T. O'Neill, who is the Director of the Office of Biostatistics within the U.S. Food and Drug Administration. Dr. O'Neill exemplifies the professional statistician who combines excellence in the areas of research, teaching and service. Dr. O'Neill contributes enormously to the public health of the United States through his tireless dedication to public service, his wise and insightful publications, and his commitment to educating statisticians involved in therapeutic drug research and clinical trials. His presentation will 1) provide an overview documenting the evolution of the current regulations and statistical involvement, 2) highlight the current methodological challenges facing the field of biostatistics within drug development, 3) underscore the international role that biostatistics, regulation and public health has assumed in the new global economy and 4) demonstrate the important link between regulation, biostatistics and public health.

Learning Objectives:

• To acquaint the participant with the critical role of biostatistics in the drug discovery, development and approval process.
• Provide an overview documenting the evolution of the current regulations and statistical involvement.
• Help the participant to understand current methodological challenges facing the field of statistics within drug development and the international role that biostatistics, regulation and public health has assumed in the new global economy.
• To understand the quantitative and biostatistical methodologies used by researchers and regulatory professionals in the drug discovery, development and approval process.
• To understand the link between biostatistical methods, the safety and effectiveness of pharmacological therapies and public health.

Keywords: Biostatistics, FDA

Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.

Recorded presentation