title: European Federation of Statisticians in the Pharmaceutical Industry's position on access to clinical trial data.
abstract: The European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) believes access to clinical trial data should be implemented in a way that supports good research, avoids misuse of such data, lies within the scope of the original informed consent and fully protects patient confidentiality. In principle, EFSPI supports responsible data sharing. EFSPI acknowledges it is in the interest of patients that their data are handled in a strictly confidential manner to avoid misuse under all possible circumstances. It is also in the interest of the altruistic nature of patients participating in trials that such data will be used for further development of science as much as possible applying good statistical principles. This paper summarises EFSPI's position on access to clinical trial data. The position was developed during the European Medicines Agency (EMA) advisory process and before the draft EMA policy on publication and access to clinical trial data was released for consultation; however, the EFSPI's position remains unchanged following the release of the draft policy. Finally, EFSPI supports a need for further guidance to be provided on important technical aspects relating to re-analyses and additional analyses of clinical trial data, for example, multiplicity, meta-analysis, subgroup analyses and publication bias.
authors.affiliation: Global Biostatistical Science, Amgen Ltd, Cambridge, UK.
authors.forename: Christine
authors.initials: C
authors.lastname: Fletcher
authors.forename: Stefan
authors.initials: S
authors.lastname: Driessen
authors.forename: Hans Ulrich
authors.initials: HU
authors.lastname: Burger
authors.forename: Christoph
authors.initials: C
authors.lastname: Gerlinger
authors.forename: Egbert
authors.initials: E
authors.lastname: Biesheuvel
mesh_terms: D022126:Access to Information; D002986:Clinical Trials as Topic; D003219:Confidentiality; D004345:Drug Industry; D005060:Europe; D006801:Humans; D007258:Informed Consent
keywords: EFSPI; access to clinical trial data; transparency