title: [Regulations concerning data transparency- a comparison between the USA and Europe].
abstract: Since 2007 a far-reaching obligation to register and publish clinical trials of pharmaceuticals on the generally accessible website www.clinicaltrials.gov has applied under the US Food and Drug Administration Amendment Act ("FDAAA") section 801. This obligation also comprises clinical trials results. In the EU clinical trials are registered with the EudraCT data base. The published data are strictly confidential and only accessible to public authorities. The publicly accessible data base Eudrapharm does not generate information on trials; there have been vague extension plans. Since 2011, § 42b of the German Drugs Act provides that the results of clinical trials need to be reported (on the "PharmNet.Bund" website) in order to improve information for doctors and patients. The US regulations serve as a role model for an approach to keeping the general public fully informed about the start and the results of clinical drug trials and to avoiding publication bias.
authors.affiliation: McGill University, Dusseldorf. quack@buse.de
authors.forename: Christian
authors.initials: C
authors.lastname: Quack
mesh_terms: D022126:Access to Information / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D003431:Cross-Cultural Comparison; D016208:Databases, Factual / Q000331:legislation & jurisprudence; D004346:Drug Information Services / Q000331:legislation & jurisprudence*; D005060:Europe; D006801:Humans; D020407:Internet / Q000331:legislation & jurisprudence*; D017594:Publication Bias; D011643:Publishing / Q000331:legislation & jurisprudence*; D012042:Registries / Q000706:statistics & numerical data; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*