title: An introductory note to CHMP guidelines: choice of the non-inferiority margin and data monitoring committees.
abstract: The Committee on Medical Products for Human Use (CHMP) has recently issued two new guidance documents that are of particular note to statisticians. The purpose of this short note is to give a little background to the origins of these documents and a flavour of some of their most important features. The two guidelines are reproduced as the next two papers in the journal.
authors.affiliation: MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, U.K.
authors.forename: David
authors.initials: D
authors.lastname: Brown
authors.forename: Peter
authors.initials: P
authors.lastname: Volkers
authors.forename: Simon
authors.initials: S
authors.lastname: Day
mesh_terms: D026661:Clinical Trials Data Monitoring Committees / Q000592:standards*; D002986:Clinical Trials as Topic / Q000592:standards*; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D004364:Pharmaceutical Preparations / Q000592:standards*; D013810:Therapeutic Equivalency
chemical_list: D004364:Pharmaceutical Preparations