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© Hummers-Pradier et al.; licensee BioMed Central Ltd. 2012. This work is published under http://creativecommons.org/licenses/by/2.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Background

In Germany, clinical trials and comparative effectiveness studies in primary care are still very rare, while their usefulness has been recognised in many other countries. A network of researchers from German academic general practice has explored the reasons for this discrepancy.

Methods

Based on a comprehensive literature review and expert group discussions, problem analyses as well as structural and procedural prerequisites for a better implementation of clinical trials in German primary care are presented.

Results

In Germany, basic biomedical science and technology is more reputed than clinical or health services research. Clinical trials are funded by industry or a single national programme, which is highly competitive, specialist-dominated, exclusive of pilot studies, and usually favours innovation rather than comparative effectiveness studies. Academic general practice is still not fully implemented, and existing departments are small. Most general practitioners (GPs) work in a market-based, competitive setting of small private practices, with a high case load. They have no protected time or funding for research, and mostly no research training or experience. Good Clinical Practice (GCP) training is compulsory for participation in clinical trials. The group defined three work packages to be addressed regarding clinical trials in German general practice: (1) problem analysis, and definition of (2) structural prerequisites and (3) procedural prerequisites. Structural prerequisites comprise specific support facilities for general practice-based research networks that could provide practices with a point of contact. Procedural prerequisites consist, for example, of a summary of specific relevant key measures, for example on a web platform. The platform should contain standard operating procedures (SOPs), templates, checklists and other supporting materials for researchers.

Conclusion

All in all, our problem analyses revealed that a substantial number of barriers contribute to the low implementation of clinical research in German general practice. Some issues are deeply rooted in Germany’s market-based healthcare and academic systems and traditions. However, new developments may facilitate change: recent developments in the German research landscape are encouraging.

Details

Title
General practice-based clinical trials in Germany - a problem analysis
Author
Hummers-Pradier, Eva 1 ; Bleidorn, Jutta 2 ; Schmiemann, Guido 3 ; Joos, Stefanie 4 ; Becker, Annette 5 ; Altiner, Attila 6 ; Chenot, Jean-François 7 ; Scherer, Martin 8 

 University Medical Centre Göttingen, Department of General Practice/Family Medicine, Göttingen, Germany (GRID:grid.411984.1) (ISNI:0000000104825331) 
 Hannover Medical School, Institute of General Practice, Hannover, Germany (GRID:grid.10423.34) (ISNI:0000000095299877) 
 University of Bremen, Institute for Public Health and Nursing Research, Department for Health Services Research, Bremen, Germany (GRID:grid.7704.4) (ISNI:0000000122974381) 
 University of Heidelberg, Department of General Practice and Health Services Research, Heidelberg, Germany (GRID:grid.7700.0) (ISNI:0000000121904373) 
 University of Marburg, Department of General Practice, Preventive and Rehabilitative Medicine, Marburg, Germany (GRID:grid.10253.35) (ISNI:0000000419369756) 
 University of Rostock, Department of General Practice, Rostock, Germany (GRID:grid.10493.3f) (ISNI:0000000121858338) 
 University of Greifswald, Department of General Practice, Institute of Community Medicine, Greifswald, Germany (GRID:grid.5603.0) 
 University Medical Centre Hamburg-Eppendorf, Institute of Primary Medical Care, Hamburg, Germany (GRID:grid.13648.38) (ISNI:0000000121803484) 
Pages
205
Publication year
2012
Publication date
Dec 2012
Publisher
BioMed Central
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2794925663
Copyright
© Hummers-Pradier et al.; licensee BioMed Central Ltd. 2012. This work is published under http://creativecommons.org/licenses/by/2.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.