title: EMEA and the evaluation of health-related quality of life data in the drug regulatory process.
authors.affiliation: Eli Lilly and Company Limited, Windlesham, Surrey, UK.
authors.forename: Sotiria
authors.initials: S
authors.lastname: Papanicolaou
authors.forename: David
authors.initials: D
authors.lastname: Sykes
authors.forename: Elias
authors.initials: E
authors.lastname: Mossialos
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D017277:Drug Approval; D015507:Drugs, Investigational / Q000592:standards*; D005062:European Union; D017408:Guidelines as Topic; D006304:Health Status; D006801:Humans; D007390:International Agencies; D017063:Outcome Assessment, Health Care / Q000592:standards*; D011788:Quality of Life / Q000331:legislation & jurisprudence*
chemical_list: D015507:Drugs, Investigational