Statistical Collaboration Benefits Regulatory Policy

• Activity Number: 621
• Type: Invited
• Date/Time: Thursday, August 7, 2014 : 10:30 AM to 12:20 PM
• Sponsor: SPAIG Committee
• Author(s): Lisa LaVange*+
• Companies: FDA
• Keywords: external collaborations ; statistics working groups

Abstract

The Office of Biostatistics provides statistical leadership and expertise in the regulation and development of drugs and therapeutic biologics by the US FDA. Our strategic plan calls for clarity of statistical policies and consistency and transparency in their application across regulatory submissions. Collaborations among statisticians and other scientists in government, industry, and academia can greatly enhance our ability to successfully carry out our public health mission. I will discuss three types of both ongoing and potential collaborations with which the office is involved, (i) collaboration with academic statisticians on development of novel statistical methodologies through MOUs and related mechanisms, (ii) participation with our colleagues from industry and academia in working groups sponsored by professional societies and formed to investigate a particular statistical topic of mutual interest, and (iii) collaboration with industry statisticians on clinical informatics initiatives to facilitate sharing of computational tools and software. Results of these various collaborations include, but are not limited to, preparation of white papers and/or peer-reviewed publica