title: Reducing the costs of phase III cardiovascular clinical trials.
abstract: BACKGROUND
  The pharmaceutical industry spends approximately 26.4 billion dollars annually for research and development (4.1 billion dollars in cardiovascular products). We compared pharmaceutical companies' planned resource use and costs in Phase III cardiovascular trials and identified cost-saving strategies.
  
  
  RESULTS
  We developed 2 case scenarios (a 17,000-patient, open-label acute coronary syndromes [ACS] trial and a 14,500-patient, double-blind congestive heart failure [CHF]) trial and surveyed 6 pharmaceutical experts about expected resources (e.g., number of sites, case report form [CRF] pages, and monitoring visits) needed for the trials. Using a validated model, we estimated costs under each expert's assumptions. ACS trial costs averaged 83 million dollars (median, 67 million dollars; range, 57 dollars to 158 million dollars) and 142 million dollars (median, 135 million dollars; range, 102 dollars to 207 million dollars) for the CHF trial. Site-related expenses (site management and payments) were >65% of total costs for both trials. In sensitivity analyses, total costs were reduced >40% by simultaneously reducing CRF pages, monitoring visits, and site-payment amounts but maintaining the numbers of patients and sites.
  
  
  CONCLUSIONS
  With a set number of sites and patients, the most efficient way to reduce trial costs and still meet the trial's scientific objectives is to reduce management complexity. Modest changes in management parameters release significant monies to answer more research questions.
authors.affiliation: Division of Cardiology, Department of Medicine, Duke University Medical Center and Duke Clinical Research Institute, Durham, NC 27715, USA. eisen006@mc.duke.edu
authors.forename: Eric L
authors.initials: EL
authors.lastname: Eisenstein
authors.forename: Philip W
authors.initials: PW
authors.lastname: Lemons
authors.forename: Barbara E
authors.initials: BE
authors.lastname: Tardiff
authors.forename: Kevin A
authors.initials: KA
authors.lastname: Schulman
authors.forename: M King
authors.initials: MK
authors.lastname: Jolly
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
mesh_terms: D017326:Clinical Trials, Phase III as Topic / Q000191:economics* / Q000379:methods; D003361:Cost Allocation / Q000379:methods; D003363:Cost Control / Q000379:methods*; D004311:Double-Blind Method; D006333:Heart Failure / Q000191:economics* / Q000628:therapy; D006801:Humans; D018803:Models, Economic; D012107:Research Design