title: Assessing the impact of ICH E9.
abstract: The ICH harmonized tripartite guideline 'Statistical Principles for Clinical Trials', more commonly referred to as ICH E9, was adopted by the regulatory bodies of the European Union, Japan and the USA in 1998. This document united related guidance documents on statistical methodology from each of the three ICH regions, and meant that for the first time clear consistent guidance on statistical principles was available to those conducting and reviewing clinical trials. At the 10th anniversary of the guideline's adoption, this paper discusses the influence of ICH E9 by presenting a perspective on how approaches to some aspects of clinical trial design, conduct and analysis have changed in that time in the context of regulatory submissions in the European Union.
authors.affiliation: Medicines and Healthcare Products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, UK.
authors.forename: David
authors.initials: D
authors.lastname: Brown
authors.forename: Simon
authors.initials: S
authors.lastname: Day
authors.forename: Rob
authors.initials: R
authors.lastname: Hemmings
authors.forename: David
authors.initials: D
authors.lastname: Wright
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D017408:Guidelines as Topic; D006801:Humans; D015337:Multicenter Studies as Topic; D012107:Research Design; D018401:Sample Size; D013223:Statistics as Topic