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New considerations in the design of clinical trials for anti-atherosclerotic drugs

Therese M Heinonen, Donald M Black

The purpose of this article is to review the current landscape of new therapeutic targets, advances in biomarkers and imaging technologies, regulatory sciences, and their collective potential impact on the development of novel anti-atherosclerosis drugs. Current development challenges such as the design of pharmacodynamic (indicative or surrogate biomarker) and ‘hard’ end point studies are reviewed. The reader can also expect to learn about advanced collaborative efforts that will likely have an impact on future initiatives.