title: Making what's advanced today routine tomorrow.
abstract: Statistical principles and ongoing proliferation of novel statistical methodologies have dramatically improved the clinical drug development process. This journey over the last seven decades reshaped the pharmaceutical industry and regulatory agencies, highlighted the importance of statistical thinking in drug development and decision-making, and, most importantly, improved the lives of countless patients around the world. Some significant highlights in the history of this journey are recounted here as well as some exciting opportunities of what the future may hold for the science and profession of statistics.
authors.affiliation: a Lilly Corporate Center, Global Statistical Sciences , Eli Lilly & Company , Indianapolis , Indiana , USA.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Ruberg
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003627:Data Interpretation, Statistical; D004345:Drug Industry; D006801:Humans; D012107:Research Design
keywords: Adaptive designs; ICH-E9; adequate and well-controlled trials; analytics strategy; bayesian statistics; interim analysis; multiplicity; noninferiority; randomization; subgroup identification