title: Beyond journal publications - a new format for the publication of clinical trials.
abstract: Journal publications are the major route to communicate methods and results of clinical trials. However, the shortcomings of this format are well known, including insufficient quality of the information provided as well as publication and outcome reporting bias. Attempts to improve the situation via peer review, reporting guidelines or study registration did not solve the problem. Currently, new ways of data presentation in electronic databases, increased access to previously confidential documents, and the potential use of anonymized individual patient data from clinical trials beyond the individual trial, have led to discussions about new publication formats for clinical trials. The current paper describes the components required for full information on a clinical trial and discusses a new format to provide this information.
authors.affiliation: Institute for Quality and Efficiency in Health Care (IQWiG), Köln, Germany. Electronic address: beate.wieseler@iqwig.de.
authors.forename: Beate
authors.initials: B
authors.lastname: Wieseler
mesh_terms: D002986:Clinical Trials as Topic; D005858:Germany; D006801:Humans; D010380:Peer Review; D017594:Publication Bias; D011643:Publishing
keywords: Bias (Epidemiologie); Publikationsbias; Publikationsformate; Verlagswesen; Zugangsrecht zu Informationen; access to information; bias (epidemiology); publication bias; publication formats; publishing