German policy-making has undertaken important steps to strengthen clinical research in Germany. However, the industry continues to complain about disadvantages in the competition with other countries. Although the number of clinical studies has been rising during the last years, this increase has been significantly bigger in some competing countries. In the long run this could impact on employment and supply of patients with innovative pharmaceuticals, as new products are introduced preferredly in those countries in which the clinical trials had taken place.
In addition, the traditional procedures of clinical research are questioned by new, mostly biotechnological therapy methods, e.g. gene or cell therapies or monoclonal anti-bodies, or by nano medicine, for which the existing evidence is still relatively weak and which therefore can hold particular risks for patients and study participants. For these new procedures, scientific development forges ahead at quick pace, so that the framework conditions in particular for the protection of the participants in clinical trials have to be re-assessed and adopted to new challenges frequently, but without hampering the carrying-out of clinical studies in Germany too much.
Aims of the project were the description and assessment of the various conditions of Germany as research location for clinical trials and an in-depth analysis for the area of biomedical innovations.
Duration: May 2007 – June 2009
Funding: Office for Technology Assessment at the German Federal Parliament (TAB)
Project lead: Bernhard Bührlen at Fraunhofer ISI
Weblink: Website of the study at TAB