Guidelines for the funding of clinical studies appeared
14.10.2011 14:35
“Clinical trials are an indispensable tool for the transfer of research findings into healthcare and a driver for innovation in health research and healthcare. They form the basis for evidence and quality in medical care,” writes Dr. Angela Lindner from the Federal Ministry of Education and Research in the foreword to the “Guidelines for the Funding of Clinical Studies” just published in the Budnesanzeiger. These - especially "confirmatory, multi-center" - studies involve a lot of scientific, time, logistical and material effort, which is why the BMBF, in close coordination with the German Research Foundation (DFG), intends to use exactly this type of study as a "contribution to the implementation of the “To promote the objectives of the Health Research Framework Program”.
According to the BMBF, it has often not been possible to establish the professionalism necessary to meet the requirements in study planning and implementation at German university hospitals on a broad scale. In addition, the quality of the studies often does not correspond to international standards. In order to improve this, a joint group of experts should be convened.
The following are explicitly supported:
-science-initiated multicenter prospective, controlled clinical studies on patients on pharmacological therapy procedures with confirmatory objectives. Monocentric confirmatory studies can only be funded in justified exceptional cases.
– systematic reviews of clinical studies according to international standards.
Excluded from funding are research approaches that have already been applied for or supported in other funding programs such as the DFG's normal procedure or other funding priorities of the BMBF, as well as studies whose results commercial companies have a direct economic interest in (such as approval studies).