title: Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA Task Force report.
abstract: OBJECTIVE
  A growing number of prospective clinical trials include economic end points. Recognizing the variation in methodology and reporting of these studies, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) chartered the Task Force on Good Research Practices: Randomized Clinical Trials-Cost-Effectiveness Analysis. Its goal was to develop a guidance document for designing, conducting, and reporting cost-effectiveness analyses conducted as a part of clinical trials.
  
  
  METHODS
  Task force cochairs were selected by the ISPOR Board of Directors. Cochairs invited panel members to participate. Panel members included representatives from academia, the pharmaceutical industry, and health insurance plans. An outline and a draft report developed by the panel were presented at the 2004 International and European ISPOR meetings, respectively. The manuscript was then submitted to a reference group for review and comment.
  
  
  RESULTS
  The report addresses issues related to trial design, selecting data elements, database design and management, analysis, and reporting of results. Task force members agreed that trials should be designed to evaluate effectiveness (rather than efficacy), should include clinical outcome measures, and should obtain health resource use and health state utilities directly from study subjects. Collection of economic data should be fully integrated into the study. Analyses should be guided by an analysis plan and hypotheses. An incremental analysis should be conducted with an intention-to-treat approach. Uncertainty should be characterized. Manuscripts should adhere to established standards for reporting results of cost-effectiveness analyses.
  
  
  CONCLUSIONS
  Trial-based cost-effectiveness studies have appeal because of their high internal validity and timeliness. Improving the quality and uniformity of these studies will increase their value to decision makers who consider evidence of economic value along with clinical efficacy when making resource allocation decisions.
authors.affiliation: Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA. sramsey@fhcrc.org
authors.forename: Scott
authors.initials: S
authors.lastname: Ramsey
authors.forename: Richard
authors.initials: R
authors.lastname: Willke
authors.forename: Andrew
authors.initials: A
authors.lastname: Briggs
authors.forename: Ruth
authors.initials: R
authors.lastname: Brown
authors.forename: Martin
authors.initials: M
authors.lastname: Buxton
authors.forename: Anita
authors.initials: A
authors.lastname: Chawla
authors.forename: John
authors.initials: J
authors.lastname: Cook
authors.forename: Henry
authors.initials: H
authors.lastname: Glick
authors.forename: Bengt
authors.initials: B
authors.lastname: Liljas
authors.forename: Diana
authors.initials: D
authors.lastname: Petitti
authors.forename: Shelby
authors.initials: S
authors.lastname: Reed
mesh_terms: D026683:Advisory Committees; D003362:Cost-Benefit Analysis / Q000379:methods*; D003627:Data Interpretation, Statistical; D004341:Drug Evaluation / Q000191:economics*; D017850:Economics, Pharmaceutical; D017408:Guidelines as Topic; D006801:Humans; D007390:International Agencies; D019057:Quality-Adjusted Life Years; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design / Q000592:standards; D018401:Sample Size