title: Driving clinical study efficiency by using a productivity breakdown model: comparative evaluation of a global clinical study and a similar Japanese study.
abstract: OBJECTIVE
  A fundamental management imperative of pharmaceutical companies is to contain surging costs of developing and launching drugs globally. Clinical studies are a research and development (R&D) cost driver. The objective of this study was to develop a productivity breakdown model, or a key performance indicator (KPI) tree, for an entire clinical study and to use it to compare a global clinical study with a similar Japanese study. We, thereby, hope to identify means of improving study productivity.
  
  
  METHODS
  We developed the new clinical study productivity breakdown model, covering operational aspects and cost factors. Elements for improving clinical study productivity were assessed from a management viewpoint by comparing empirical tracking data from a global clinical study with a Japanese study with similar protocols.
  
  
  RESULTS
  The following unique and material differences, beyond simple international difference in cost of living, that could affect the efficiency of future clinical trials were identified: (i) more frequent site visits in the Japanese study, (ii) head counts at the Japanese study sites more than double those of the global study and (iii) a shorter enrollment time window of about a third that of the global study at the Japanese study sites.
  
  
  CONCLUSIONS
  We identified major differences in the performance of the two studies. These findings demonstrate the potential of the KPI tree for improving clinical study productivity. Trade-offs, such as those between reduction in head count at study sites and expansion of the enrollment time window, must be considered carefully.
authors.affiliation: Pharmaco-Business Innovation Laboratory, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Takahashi
authors.forename: S
authors.initials: S
authors.lastname: Sengoku
authors.forename: H
authors.initials: H
authors.lastname: Kimura
mesh_terms: D035843:Biomedical Research / Q000191:economics / Q000458:organization & administration*; D002986:Clinical Trials as Topic / Q000191:economics; D003365:Costs and Cost Analysis; D004345:Drug Industry / Q000379:methods; D017598:Efficiency, Organizational / Q000191:economics; D006801:Humans; D033183:Interdisciplinary Communication; D038622:Internationality; D007564:Japan; D018803:Models, Economic; D017146:Models, Organizational; D018579:Patient Selection; D013997:Time Factors