title: Key cost drivers of pharmaceutical clinical trials in the United States.
abstract: BACKGROUND
  The increasing cost of clinical research has significant implications for public health, as it affects drug companies' willingness to undertake clinical trials, which in turn limits patient access to novel treatments. Thus, gaining a better understanding of the key cost drivers of clinical research in the United States is important.
  
  
  OBJECTIVE
  The study which is based on a report prepared by Eastern Research Group, Inc., for the US Department of Health and Human Services, examined different factors, such as therapeutic area, patient recruitment, administrative staff, and clinical procedure expenditures, and their contribution to pharmaceutical clinical trial costs in the United States by clinical trial phase.
  
  
  METHODS
  The study used aggregate data from three proprietary databases on clinical trial costs provided by Medidata Solutions. We evaluated per-study costs across therapeutic areas by aggregating detailed (per patient and per site) cost information. We also compared average expenditures on cost drivers with the use of weighted mean and standard deviation statistics.
  
  
  RESULTS
  Therapeutic area was an important determinant of clinical trial costs by phase. The average cost of a Phase 1 study conducted at a US site ranged from US$1.4 million (pain and anesthesia) to US$6.6 million (immunomodulation), including estimated site overhead and monitoring costs of the sponsoring organization. A Phase 2 study cost from US$7.0 million (cardiovascular) to US$19.6 million (hematology), whereas a Phase 3 study cost ranged from US$11.5 million (dermatology) to US$52.9 (pain and anesthesia) on average. Across all study phases and excluding estimated site overhead costs and costs for sponsors to monitor the study, the top three cost drivers of clinical trial expenditures were clinical procedure costs (15%-22% of total), administrative staff costs (11%-29% of total), and site monitoring costs (9%-14% of total).
  
  
  CONCLUSIONS
  The data were from 2004 through 2012 and were not adjusted for inflation. Additionally, the databases used represented a convenience, that is, non-probability, sample and did not allow for statistically valid estimates of cost drivers. Finally, the data were from trials funded by the global pharmaceutical and biotechnology industry only. Hence, our study findings are limited to that segment.
  
  
  CONCLUSIONS
  Therapeutic area being studied as well as number and types of clinical procedures involved were the key drivers of direct costs in Phase 1 through Phase 3 studies. Research shows that strategies exist for reducing the price tag of some of these major direct cost components. Therefore, to increase clinical trial efficiency and reduce costs, gaining a better understanding of the key direct cost drivers is an important step.
authors.affiliation: Eastern Research Group, Inc., Lexington, MA, USA aylin.sertkaya@erg.com.
authors.forename: Aylin
authors.initials: A
authors.lastname: Sertkaya
authors.affiliation: Office of Science and Data Policy, Office of the Assistant Secretary for Planning and Evaluation, US Department of Health and Human Services, Washington, DC, USA.
authors.forename: Hui-Hsing
authors.initials: HH
authors.lastname: Wong
authors.affiliation: Office of Science and Data Policy, Office of the Assistant Secretary for Planning and Evaluation, US Department of Health and Human Services, Washington, DC, USA.
authors.forename: Amber
authors.initials: A
authors.lastname: Jessup
authors.affiliation: Office of the Commissioner, Food and Drug Administration, USA Department of Health and Human Services, Silver Spring, MD, USA.
authors.forename: Trinidad
authors.initials: T
authors.lastname: Beleche
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics*; D003365:Costs and Cost Analysis; D016208:Databases, Factual; D000071220:Pharmaceutical Research; D014481:United States
keywords: Clinical trial cost; administrative staff costs; clinical procedure costs; cost drivers; site monitoring costs; site retention costs