title: [Legal status and organization of homeopathic drug testing in Germany].
abstract: For more than 200 years, homeopathic doctors have been carrying out homeopathic drug provings (HDPs),which embodies the traditional self drug testing, an integral part of the homeopathic medical profession. However,according to national authorities, testing homeopathic drugs is a phase I clinical trial for which the German Federal Drug Law applies. Adapting a 200-year-old primary qualitative study design to modern drug law and Good Clinical Practice Guidelines generates several difficulties, in particular, blinding, informed consent and the classification of adverse events. In addition, in Germany naturopaths (German: ‘Heilpraktiker’) are excluded from leading HDP trials. The costs are climbing, and the organizational over heads for a HDP are enormous. Implications for the future are discussed.
authors.affiliation: Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité Universitätsmedizin Berlin, Deutschland.
authors.forename: Michael
authors.initials: M
authors.lastname: Teut
authors.forename: Ute
authors.initials: U
authors.lastname: Hirschberg
authors.forename: Michael K
authors.initials: MK
authors.lastname: Elies
authors.forename: Rainer
authors.initials: R
authors.lastname: Lüdtke
authors.forename: Henning
authors.initials: H
authors.lastname: Albrecht
authors.forename: Jörn
authors.initials: J
authors.lastname: Dahler
authors.forename: Christoph
authors.initials: C
authors.lastname: Schnegg
authors.forename: Claudia M
authors.initials: CM
authors.lastname: Witt
mesh_terms: D017321:Clinical Trials, Phase I as Topic; D004353:Drug Evaluation, Preclinical / Q000191:economics; D005858:Germany; D006705:Homeopathy / Q000331:legislation & jurisprudence* / Q000379:methods*; D006801:Humans