Examination of Clinical Trial Costs and Barriers for Drug Development. E.2 Analysis of Costs


The model uses detailed cost information made available by Medidata Solutions, a global provider of cloud-based solutions for clinical research in life sciences. The cost information is specific to the U.S. and presented by therapeutic area and clinical trial phase. Key findings with respect to costs include the following:

  • Overall, the therapeutic area with the highest average per-study costs across Phases 1, 2 and 3 is pain and anesthesia ($71.3 million) followed by ophthalmology ($49.9 million) and antiinfective ($41.3 million) trials. Conversely, trials in dermatology, endocrinology, and gastroenterology have the lowest overall costs across the same three phases.
  • Average per-study costs across all therapeutic areas increase as clinical development proceeds from Phase 1 to Phases 2 and 3. Average Phase 4 study costs are equivalent to those of Phase 3 costs but are much more variable across different therapeutic areas than Phase 3 costs.
  • Overall, the factors that contribute the most to costs across all trial phases include Clinical Procedure Costs (15 to 22 percent), Administrative Staff Costs (11 to 29 percent), Site Monitoring Costs (nine to 14 percent), Site Retention Costs (nine to 16 percent), and Central Laboratory Costs (four to 12 percent).

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