Title: Statistics at FDA: Reflections on the Past Six Years
Abstract:A year after joining the FDA in 2011 as Director of the Office of Biostatistics in the Center for Drug Evaluation and Research (CDER), I prepared a talk, and later a publication, on the role of statis...A year after joining the FDA in 2011 as Director of the Office of Biostatistics in the Center for Drug Evaluation and Research (CDER), I prepared a talk, and later a publication, on the role of statistics in regulatory decision making (LaVange, 2013 LaVange, L. M. (2013), “The Role of Statistics in Regulatory Decision Making,” Therapeutic Innovation & Regulatory Science, 48, 12–19.[Web of Science ®] , [Google Scholar]). In that 2013 paper, I described the many challenges statisticians face in drug regulation and suggested some pathways for addressing them. After six years on the job, I returned to academia and spent some time revisiting my first impressions about statistics at FDA. Had any of the challenges been successfully met? What new challenges have replaced them? Here, I recount some experiences from those six years (2011–2017), focusing on areas where statistics has had a positive impact on the work of FDA. Specific topics include growth and workforce issues; development and dissemination of statistical policy and guidance; a new way of thinking about missing data, estimands, and sensitivity analysis; the challenges that subgroup inference poses; the future of precision medicine and the role of master protocols in that future; the heartbreak inherent in studying and regulating products for rare diseases, and an attempt to answer the question, “Is it time for Bayesian methods to be seriously considered by CDER?”Read More
Publication Year: 2019
Publication Date: 2019-01-02
Language: en
Type: article
Indexed In: ['crossref']
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Cited By Count: 10
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