Abstract
BackgroundIn 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.MethodsBased 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.ResultsIn 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.ConclusionAll 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.
Highlights
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
This paper presents the main results of the problem analysis and highlights the steps for the network and future development of clinical research in German general practice generally
Literature referring to prerequisites and circumstances specific to conducting clinical trials studies in primary care settings was retrieved in PubMed (2000 to 2012) searching for the MeSH term ‘Randomized Controlled Trials as Topic’ and keywords ‘primary care/general practice/family practice’ as well as ‘feasibility’, ‘recruitment’, and ‘design’
Summary
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. In the US, major funding programmes have been launched to facilitate comparative effectiveness studies, many of which are expected to be primary carebased or to tackle public health needs, and translational research with an outreach into primary care [6,7,8]. The UK-led European TRANSFoRm project aims to interlink and extend existing databases of electronic patient records, and to provide electronic support to practice networks in order to facilitate clinical trials and comparative effectiveness research in primary care [14,15]. Practice-based research networks cooperate closely with specific coordinating centres, often academic departments for general practice, or specific, publicly funded research institutes for primary health care research
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