title: General practice-based clinical trials in Germany - a problem analysis.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of General Practice/Family Medicine, University Medical Centre Göttingen, Humboldtallee 38, 37073, Göttingen, Germany. eva.hummers-pradier@med.uni-goettingen.de
authors.forename: Eva
authors.initials: E
authors.lastname: Hummers-Pradier
authors.forename: Jutta
authors.initials: J
authors.lastname: Bleidorn
authors.forename: Guido
authors.initials: G
authors.lastname: Schmiemann
authors.forename: Stefanie
authors.initials: S
authors.lastname: Joos
authors.forename: Annette
authors.initials: A
authors.lastname: Becker
authors.forename: Attila
authors.initials: A
authors.lastname: Altiner
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Chenot
authors.forename: Martin
authors.initials: M
authors.lastname: Scherer
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics / Q000379:methods* / Q000592:standards; D057186:Comparative Effectiveness Research / Q000191:economics / Q000379:methods* / Q000458:organization & administration / Q000592:standards; D058006:General Practice / Q000191:economics / Q000458:organization & administration / Q000592:standards; D005858:Germany; D017048:Health Care Costs; D006801:Humans; D017146:Models, Organizational; D011320:Primary Health Care / Q000191:economics / Q000458:organization & administration / Q000592:standards; D012107:Research Design / Q000592:standards; D012109:Research Support as Topic; D013997:Time Factors; D016526:Workload