title: [Sense and nonsense in post-authorization surveillance].
abstract: Post-authorization surveillance studies analyze the intended use of medications in accordance with their authorized labeling. They are characterized by the principle of non-intervention, i.e. they do not take influence on the decision whether or how to treat and to survey treatment in the individual patient. These aspects define the difference between surveillance studies and phase-IV clinical trials. In consequence, surveillance studies--in contrast to phase-IV trials--are not subject to the regulations of sections 40, 41 of the German Drug Law and national and international Recommendations on Good Clinical Practice (GCP). In essence, they are pharmaco-epidemiological investigations that make use of personified patient data. Within the context of the European regulatory policies they are part of the overall pharmacovigilance effort. In Germany, surveillance studies may have an additional regulatory impact. Indeed, they may be accepted as a relevant extension to the documentation on both safety and efficacy and in some cases even as an alternative to the tedious experimental investigation thereof, provided they meet newly defined quality criteria (that are discussed here more extensively). Although not developed to this purpose and although these recommendations are mainly formal with some relevant shortcomings in defining content quality, they are an important source of reference for the individual physician to guide his decision about the value and acceptability of any surveillance study, including those not primarily intended to be used in a regulatory context.
authors.affiliation: CdeMey@t-online.de
authors.forename: C
authors.initials: C
authors.lastname: de Mey
mesh_terms: D017327:Clinical Trials, Phase IV as Topic / Q000706:statistics & numerical data*; D003627:Data Interpretation, Statistical; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D015203:Reproducibility of Results
vernacular_title: Sinn und Unsinn von Anwendungsbeobachtungen.