Professional Ethics to FDA Statisticians: Fundamentals and Branching Out to Other Professional Settings

• Activity Number: 55
• Type: Invited
• Date/Time: Sunday, August 4, 2013 : 4:00 PM to 5:50 PM
• Sponsor: Committee on Professional Ethics
• Author(s): Jeongsook (Jessica) Kim*+
• Companies: FDA/CBER
• Keywords: ethical codes ; FDA ; professional statistician

Abstract

Regulatory decision makers rely on data from clinical trials, surveys, registries and other data sources to address scientific questions using statistical evaluation. In recent years, professional statisticians in academia, industry, and the government have played an important collaborative role in collecting, analyzing, and interpreting information from such studies. In this talk, we will discuss the fundamental elements of professional ethics in statistics that we believe should be covered early on in a practicing statistician's career. We will introduce the FDA statisticians' unique role as primary users of confidential information in drug development. Also, FDA statisticians often collaborate with regulated industry and academia to develop best practices, and as such should be aware of the significance of the ethical aspects in conducting their interdisciplinary work in making public decisions. In general, FDA statisticians who are exposed to these considerations should be more aware of the importance of the ethical codes applicable to statistical practice. "This presentation reflects the views of the author and should not be construed to represent FDA's views or policies."