title: [The 12th amendment to the German Drug Law. Chances and obstacles for investigator-initiated clinical trials].
abstract: The European Union's so called Clinical Trials Directive 2001/20/EC was implemented in national law in Germany in August 2004, leading to the 12th amendment of the German Drug Law (Arzneimittelgesetz). The directive is intended to harmonize the clinical trial's regulatory environment across the European Union and to improve protection of human subjects. It lays down the principles and guidelines of Good Clinical Practice (GCP). As the regulation applies to all clinical trials on medicinal products for human use, and as only non-interventional studies are excluded, academic, investigator-initiated clinical trials will also have to comply with the EU clinical trials directive implemented in the German Drug Law. In an investigator-initiated trial in which the investigator takes the responsibility of a sponsor, the investigator-sponsor must take total legal and financial responsibility for the clinical trial. Since publicly funded clinical trials make a large contribution to improved care, concern has been expressed that non-commercial research projects will be reduced and the vital medical research conducted at academic institutions curtailed. Nonetheless GCP ensures a valid study design, qualified data management, analysis and monitoring of the trial and thereby promotes more valid data and protection of study participants. The trials are more likely to lead to reliable results leading to new therapies, strategies or a better understanding of diseases. What is needed, therefore, is an increase in public funding and the establishment of clinical trial units/organizations associated with the universities or hospitals where independent researchers have the possibility to obtain theoretical advice and practical help, professional training and support. In the end, the directive may serve as a stimulus to build a better national research environment and to promote public funding, and may lead to fewer but more valid clinical trials.
authors.affiliation: Universitätsklinikum, Freiburg. dreier@zks.uni-freiburg.de
authors.forename: G
authors.initials: G
authors.lastname: Dreier
authors.forename: C
authors.initials: C
authors.lastname: Marx
authors.forename: C
authors.initials: C
authors.lastname: Schmoor
authors.forename: H
authors.initials: H
authors.lastname: Maier-Lenz
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D016494:Computer Security / Q000331:legislation & jurisprudence; D016265:Conflict of Interest / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence; D064420:Drug-Related Side Effects and Adverse Reactions; D005858:Germany; D019983:Guideline Adherence / Q000331:legislation & jurisprudence*; D006801:Humans; D007880:Legislation, Drug; D011786:Quality Control; D012106:Research