CommentaryAtherosclerosis

# Atherosclerosis Drug Development in Jeopardy: The Need for Predictive Biomarkers of Treatment Response

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Science Translational Medicine  02 Mar 2011:
Vol. 3, Issue 72, pp. 72cm6
DOI: 10.1126/scitranslmed.3002029

### Tables

• 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.

 Variable Preclinical Phase I Phase II Phase III Regulatory Total Subject number N/A 100 500 to 1000 15,000 N/A ~16,000 Cost/subject N/A $15K$19K $23K N/A Cost/phase$3M $15M$19M $345M$20M \$402M