title: Health economic evaluations alongside clinical trials: a review of study protocols at the Swedish Medical Products Agency.
abstract: OBJECTIVE
  Conducting economic evaluation in the context of clinical studies is common but has been the subject of extensive discussion due to its limitations. Various standard approaches and guidelines how such studies should be conducted have been proposed, but there is very limited information available about how common these studies are, what type of data that is collected, and how the quality of the protocols compares to the suggested standards. This study examines the prevalence and study design of health economic evaluations conducted alongside clinical trials in Sweden between 1995 and 2005.
  
  
  METHODS
  A systematic assessment of clinical trial protocols that had arrived as applications to the Medical Products Agency between 1995 and 2005 was performed. Only protocols arriving during the first half of odd years within the time period were included.
  
  
  RESULTS
  A total number of 680 protocols from 1995 to 2005 were examined, and among them, 14.4 percent included a health economic part. With the exception of year 2001, a trend toward an increased prevalence of economic evaluations next to clinical trials can be seen.
  
  
  CONCLUSIONS
  This study shows that economic evaluations alongside clinical trials are becoming more common, although most trials still lack a health economic part of the protocol. The information about the economic evaluation provided in the protocols is in many cases scarce, possibly due to the fact that there currently are no generally accepted and applied guidelines for economic evaluations in clinical trial protocols. Introducing requirements for detailed study plans also for the economic evaluation should improve the quality of economic evaluations alongside clinical trials.
authors.affiliation: Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden. Anne.Lindfors@ki.se
authors.forename: Anne
authors.initials: A
authors.lastname: Lindfors
authors.forename: Nils
authors.initials: N
authors.lastname: Feltelius
authors.forename: Jonas
authors.initials: J
authors.lastname: Lundkvist
mesh_terms: D002985:Clinical Protocols; D017326:Clinical Trials, Phase III as Topic / Q000379:methods*; D017327:Clinical Trials, Phase IV as Topic / Q000379:methods*; D003365:Costs and Cost Analysis; D017850:Economics, Pharmaceutical; D006801:Humans; D012107:Research Design; D013548:Sweden