Clinical research is of paramount relevance for the development of new pharmaceuticals and other medical treatments as well as for securing and optimisation of their application in routine practice. All clinical studies are regulated by the German pharmaceuticals law (Arzneimittelgesetz, AMG), insofar as they assess the efficacy, safety or metabolisation of pharmaceuticals with the aim to test their safety of efficacy. This type of clinical studies is called "clinical trial" ("klinische Prüfung").
To describe and assess the initial situation, data on the frequency of non-commercial studies in Germany as well as on their goals and financing were collected in a written survey. The actual discurse was analysed empirically for completeness from the perspectives of all relevant stakeholder groups and its agenda was supplemented by issues that had been neglected earlier. The practical relevance of single factors was evaluated on the basis of the survey data as well as of expert interviews and the results of a stakeholder workshop. The final report describes and assesses the manifold factors which exert influence on a powerful non-commercial clinical research in Germany and makes suggestions for the further optimisation of its framework conditions including a priorisation of the most important options for action.
Duration: Oct. 2008 – March 2010
Funding: Office for Technology Assessment at the German Federal Parliament (TAB)
Project lead: Bernhard Bührlen at Fraunhofer ISI
Weblink: Website of the study at the TAB