title: [Consequences of the 12th AMG amendment on the conduct of non-commercial clinical trials].
abstract: In 2004, the German Drug Law was reformed substantially putting into effect the European directive 2001/20/EG on Good Clinical Practice (GCP). Investigator initiated trials have to comply with the same requirements as clinical trials for drug development. When registered drugs are used in non-commercial clinical trials some simplifications are possible.Currently, all essential elements of GCP, such as financing of the trial, laying-down of sponsor responsibilities, establishing an extensive quality assurance system as well as immediate reporting of unexpected serious drug reactions, are stipulated by law. Since regulatory authorities and ethics committees have to approve every clinical trial, surveillance is reinforced. The new requirements cannot be met without sufficient financing, qualified personnel and professional structures for clinical trials. Compared to European partners, the research location Germany is at a disadvantage due to high administrative workload and costs.
authors.affiliation: Deutsche Krebsgesellschaft e. V., Studienhaus Onkologie, Steinlestrasse 6, 60596 Frankfurt/Main. rossion@krebsgesellschaft.de
authors.forename: I
authors.initials: I
authors.lastname: Rossion
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics* / Q000331:legislation & jurisprudence* / Q000639:trends; D003132:Commerce; D030881:Disclosure / Q000331:legislation & jurisprudence / Q000639:trends; D017277:Drug Approval / Q000191:economics* / Q000331:legislation & jurisprudence*; D015195:Drug Design; D005062:European Union / Q000458:organization & administration; D005858:Germany; D033161:Government Regulation; D019983:Guideline Adherence; D017408:Guidelines as Topic; D007880:Legislation, Drug / Q000458:organization & administration*; D019221:Mandatory Reporting