Impact of therapeutic investigator initiated trials on medical practice

患者和卫生专业人员应当能够考虑和评价医学研究提供的所有证据，以便就健康问题作出知情的决定，但卫生保健方面的决定往往只能根据那些已发表和可获得的研究结果作出。如果只有部分现有证据可以在以后使用，卫生保健建议可能会有偏见，并导致不适当的决定。因此，所有的研究结果都必须发表，这样医生才能根据对所有证据的评估来治疗他们的病人，进一步的研究可能不会被误导，稀缺的资源不会被浪费。德国研究基金会（DFG）和联邦教育和研究部（BMBF）制定了大型项目，以促进学术领域的高质量临床研究。这些研究者发起的试验（iit）涵盖了医学研究的所有领域，往往超出了行业赞助试验（ist）的范围。例如，iit对于验证已获得许可的医药产品的有效性和安全性以及检测医药产品（如罕见疾病）的标签外使用至关重要。但人们对iit结果对医疗实践的影响知之甚少。因此，我们的目标是在一项准实验研究中调查2005年至2012年间完成的一组确定的iit（包括所有DFG和BMBF资助的试验）以及一组ist的研究影响，包括结果是否被1)发表，2)被他人引用，特别是在系统评价和荟萃分析中，以及3)进入临床指南并因此进入医疗实践。

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.