Table 1. Summary of participant numbers, cost per participant, and cost per phase for atherosclerosis drug development programs.

Data are derived from recent drug development programs (1719) or publicly available data (37). The cost per phase was derived by multiplying subject number per phase and the corresponding cost per subject per phase. In order to show a reduction in clinical events (such as myocardial infarction), a large number of participants must be recruited, which also demands a large financial investment. Phase II biomarkers, therefore, must provide a high-quality and decisive assessment of whether to commit to phase III. Additional cost may be incurred depending on technologies used and other issues.

VariablePreclinicalPhase IPhase IIPhase IIIRegulatoryTotal
Subject numberN/A100500 to 100015,000N/A~16,000
Cost/subjectN/A$15K$19K$23KN/A
Cost/phase$3M$15M$19M$345M$20M$402M