Impact of therapeutic investigator initiated trials on medical practice

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Patients and health professionals should be able to consider and appraise all the evidence available from medical research in order to make informed decisions about health issues, but often decisions in healthcare can only be made on the basis of those research results that were published and accessible. If only part of the existing evidence can be used later, health care recommendations can be biased and lead to inappropriate decisions. Therefore it is essential that all research results are published so that doctors can treat their patients based on an appraisal of all evidence and that further research may not be misled and scarce resources not wasted. The German Research Foundation (DFG) and the Federal Ministry of Education and Research (BMBF) set out large programmes to foster high quality clinical research in the academic area. These investigator-initiated trials (IITs) cover all areas of medical research and often go beyond the scope of industry sponsored trials (ISTs). For example, IITs are essential to verify the efficacy and safety of medicinal products that are already licensed and to test the off-label use of medicinal products e.g. in rare diseases. But little is known about the impact of the results of IITs on medical practice. Therefore we aim to investigate in a quasi-experimental study the research impact of a defined set of IITs (including all DFG and BMBF funded trials) as well as of a set of ISTs, completed in the years 2005 to 2012, with respect to whether results were 1) published 2) cited by others, especially in systematic reviews and meta-analyses, and 3) found their way into clinical guidelines and therefore to medical practice.