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Driving clinical study efficiency by using a productivity breakdown model: comparative evaluation of a global clinical study and a similar Japanese study
Author(s) -
Takahashi K.,
Sengoku S.,
Kimura H.
Publication year - 2011
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1111/j.1365-2710.2010.01158.x
Subject(s) - productivity , operations management , clinical trial , tracking (education) , observational study , quality (philosophy) , clinical study , affect (linguistics) , medicine , computer science , risk analysis (engineering) , environmental economics , business , environmental resource management , psychology , engineering , surgery , environmental science , economics , pedagogy , philosophy , communication , epistemology , macroeconomics
Summary What is known and 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 enrolment time window of about a third that of the global study at the Japanese study sites. What is new and conclusion: 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 headcount at study sites and expansion of the enrolment time window, must be considered carefully.