title: Does participation in clinical trials influence the costs of future management of patients?
abstract: BACKGROUND
  An earlier study showed that from a societal perspective it was less expensive to encourage patients to self-regulate their medication for GERD (gastro-esophageal reflux disease) by treating patients on-demand.
  
  
  OBJECTIVE
  The objective was to investigate whether physician involvement in a clinical trial financed by the pharmaceutical industry subsequently results in higher health care costs.
  
  
  METHODS
  An open, observational, multicenter study compared direct medical costs and total costs for three groups of patients with different exposure to the clinical trial; (1) Dual exposed, where both the patients and the GP participated in the former clinical trial, (2) GP exposed, where only the GP participated in the former clinical trial and (3) nonexposed, where neither the patients nor the GP participated in the former clinical trial.
  
  
  RESULTS
  We did not find any statistically significant differences in neither direct medical nor total costs. However, we did observe a numerical difference in direct medical costs of 24% higher in the dual exposed group compared to the nonexposed group mainly due to a higher consumption of prescribed medication. The higher direct medical cost in the dual exposed group was however counterbalanced by lower observed direct nonmedical and indirect costs.
  
  
  CONCLUSIONS
  Although we did not find any statistical significant differences in health care costs, we did observe a higher consumption of prescribed medication and lower costs of work hours lost if both patient and GPs participated in a former clinical trial. The results may be limited due to a lower number of patients included than expected.
authors.affiliation: Danish Institute for Health Services Research, 27-29 Dampfaergevej, 2100, Copenhagen, Denmark. ah@dsi.dk
authors.forename: Anne
authors.initials: A
authors.lastname: Hvenegaard
authors.forename: Henrik Hauschildt
authors.initials: HH
authors.lastname: Juhl
authors.forename: Andreas
authors.initials: A
authors.lastname: Habicht
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics*; D003718:Denmark; D005764:Gastroesophageal Reflux / Q000188:drug therapy / Q000191:economics*; D017048:Health Care Costs / Q000706:statistics & numerical data*; D006801:Humans; D010358:Patient Participation / Q000191:economics*; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D011446:Prospective Studies; D013223:Statistics as Topic
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