title: Guidelines for the implementation of drug utilization observation (DUO) studies in psychopharmacological therapy. The "Phase IV Research" Task-Force of the Association for Neuropsychopharmacology and Pharmacopsychiatry (AGNP).
abstract: The task-force on Phase-IV-Research of the Association for Neuropharmacology and Pharmacopsychiatry (AGNP) has developed guidelines for the implementation of scientifically sound drug utilisation observation studies (DUO studies). These guidelines have been adopted by the executive committee as the position of the association. DUO studies are prospective pharmacoepidemiological studies, by which prescription, illness, and patient data of individual patients are collected without interference with the routine course of treatment. They can answer questions on the interaction of treatment modalities with positive and negative treatment outcome. Scientific standards require that there is a study protocol which describes the epidemiological, statistical, procedural, and quality assurance methodology and states who is responsible for what. As such studies can violate data protection regulations or can be used for sales instead of scientific purposes, consultation of an ethics committee is recommended.
authors.affiliation: Department of Psychiatry, Free University of Berlin, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Linden
authors.forename: D
authors.initials: D
authors.lastname: Baier
authors.forename: H
authors.initials: H
authors.lastname: Beitinger
authors.forename: R
authors.initials: R
authors.lastname: Kohnen
authors.forename: M
authors.initials: M
authors.lastname: Osterheider
authors.forename: M
authors.initials: M
authors.lastname: Philipp
authors.forename: D E
authors.initials: DE
authors.lastname: Reimitz
authors.forename: B
authors.initials: B
authors.lastname: Schaaf
authors.forename: H J
authors.initials: HJ
authors.lastname: Weber
mesh_terms: D017327:Clinical Trials, Phase IV as Topic / Q000331:legislation & jurisprudence / Q000592:standards*; D017723:Drug Utilization Review / Q000331:legislation & jurisprudence / Q000592:standards*; D004812:Epidemiologic Methods; D004991:Ethics, Institutional; D005062:European Union; D006801:Humans; D011619:Psychotropic Drugs / Q000009:adverse effects / Q000627:therapeutic use*; D012107:Research Design
chemical_list: D011619:Psychotropic Drugs