title: Biopharmaceutical statistics in a pharmaceutical regulated environment: past, present, and future.
abstract: The practice of statistics in the pharmaceutical industry has changed markedly over the last 25 years. This paper examines the evolution of clinical trial statistics in relationship to advances in statistical methodology and computational power as well as the changing regulatory environment. The current role of the biopharmaceutical statistician is assessed along with the drivers for future change.
authors.affiliation: GlaxoSmithKline, Research Triangle Park, North Carolina 27709-3398, USA.
authors.forename: A C
authors.initials: AC
authors.lastname: Segreti
authors.forename: H M
authors.initials: HM
authors.lastname: Leung
authors.forename: G G
authors.initials: GG
authors.lastname: Koch
authors.forename: R L
authors.initials: RL
authors.lastname: Davis
authors.forename: N R
authors.initials: NR
authors.lastname: Mohberg
authors.forename: K E
authors.initials: KE
authors.lastname: Peace
mesh_terms: D001702:Biopharmaceutics / Q000266:history* / Q000706:statistics & numerical data; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D017277:Drug Approval / Q000266:history; D004345:Drug Industry / Q000266:history* / Q000706:statistics & numerical data; D005544:Forecasting; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000266:history / Q000706:statistics & numerical data