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• W2942203282 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 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?”" @default.
• W2942203282 created "2019-05-03" @default.
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• W2942203282 date "2019-01-02" @default.
• W2942203282 modified "2023-10-17" @default.
• W2942203282 title "Statistics at FDA: Reflections on the Past Six Years" @default.
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• W2942203282 doi "https://doi.org/10.1080/19466315.2019.1571322" @default.
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