Examination of Clinical Trial Costs and Barriers for Drug Development. 3.2 Costs by Trial Phase


To compare average costs by phase across all therapeutic areas, we computed a weighted mean cost, Xij, and its weighted standard deviation, sij , , for each cost component, i, and clinical trial phase, j, where the weights are the total number of contracts (i.e., sum of investigator and contractor contracts contributing to the PICAS® and CROCAS® datasets11) such that

Formula1: Compare average costs

where wjis the total number of contracts available for the phase and therapeutic area, k, combination; xijk is the reported mean for cost component i, clinical trial phase j, and therapeutic area k;Xij is the simple average of cost component i for that phase j across all therapeutic areas;Ni is the number of therapeutic areas that are associated with the phase in question; and Ni' is the number of non-zero weights. As one would expect, the average per-study costs across all therapeutic areas increase as clinical development proceeds from Phase 1 to Phases 2 and 3 (see Figure 4).

Figure 4: Average Per-Study Costs by Phase (in $ Millions) Across Therapeutic Areas

Figure 4: Average Per-Study Costs by Phase (in $ Millions) Across Therapeutic Areas

Note: The error bars represent one standard deviation below and above the mean.

While average Phase 4 study costs are equivalent to those of Phase 3, there is high degree of variability in Phase 4 costs across the different therapeutic areas.

11 The number of contracts by therapeutic area and trial phase cannot be publicly reported because they are confidential and proprietary.

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