title: [Lessons learnt from 15 years of investigator-initiated trials on axial spondyloarthritis].
abstract: BACKGROUND
  Clinical research is receiving an increasing amount of attention and is essential for improving treatment of patients with rheumatic diseases.
  
  
  OBJECTIVE
  This article reports on 15 years of experience with conducting investigator-initiated studies on axial spondyloarthritis including ankylosing spondylitis.
  
  
  RESULTS
  We have organized and successfully conducted a series of open-labelled and placebo-controlled double-blind treatment studies and also non-interventional studies on this topic. The installation of a qualified and motivated trial unit and intensive collaboration with a statistician were crucial requirements for success. These results have increased our knowledge about the disease and changed and improved the diagnostic possibilities and the therapeutic options.
  
  
  CONCLUSIONS
  Investigator-initiated trials are an important link between basic and clinical research and can substantially contribute to improvement of patient care. This kind of research should be more systematically funded in the future.
authors: Med. Klinik I, Rheumatologie, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12200, Berlin, Deutschland, joachim.sieper@charite.de.
authors: J
authors: J
authors: Sieper
authors: J
authors: J
authors: Braun
mesh_terms: D018501:Antirheumatic Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods*; D003627:Data Interpretation, Statistical; D005858:Germany / Q000453:epidemiology; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods*; D015995:Prevalence; D012307:Risk Factors; D013167:Spondylitis, Ankylosing / Q000188:drug therapy* / Q000453:epidemiology*; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents