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Research ethics

Clinical research projects at a German medical faculty: follow-up from ethical approval to publication and citation by others

¹ Department of Medical Biometry and Statistics, University Medical Center, Freiburg, Germany
² Research Ethics Committee, University Medical Center, Freiburg, Germany
³ Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland

Correspondence to:
Dr A Blümle, Department of Medical Biometry and Statistics, Institute of Medical Biometry and Medical Informatics, University Medical Center Freiburg, Stefan Meier Strasse 26, 79104 Freiburg, Germany; bluemle{at}cochrane.de

Background: Only data of published study results are available to the scientific community for further use such as informing future research and synthesis of available evidence. If study results are reported selectively, reporting bias and distortion of summarised estimates of effect or harm of treatments can occur. The publication and citation of results of clinical research conducted in Germany was studied.

Methods: The protocols of clinical research projects submitted to the research ethics committee of the University of Freiburg (Germany) in 2000 were analysed. Published full articles in several databases were searched and investigators contacted. Data on study and publication characteristics were extracted from protocols and corresponding publications.

Results: 299 study protocols were included. The most frequent study design was randomised controlled trial (141; 47%), followed by uncontrolled studies (61; 20%), laboratory studies (30; 10%) and non-randomised studies (29; 10%). 182 (61%) were multicentre studies including 97 (53%) international collaborations. 152 of 299 (51%) had commercial (co-)funding and 46 (15%) non-commercial funding. 109 of the 225 completed protocols corresponded to at least one full publication (total 210 articles); the publication rate was 48%. 168 of 210 identified publications (80%) were cited in articles indexed in the ISI Web of Science. The median was 11 citations per publication (range 0–1151).

Conclusions: Results of German clinical research projects conducted are largely underreported. Barriers to successful publication need to be identified and appropriate measures taken. Close monitoring of projects until publication and adequate support provided to investigators may help remedy the prevailing underreporting of research.

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