AI Article Synopsis
- Surrogate endpoints are crucial for validating drug mechanisms, providing early proof of concept, and designing effective clinical trials for drug approval.
- Recent drug failures in peripheral arterial disease (PAD) and atherosclerosis emphasize the need for better understanding and improvement of drug effect endpoints.
- This review discusses the current status of surrogate endpoints in PAD and explores new imaging approaches that could enhance study design in this area.
Article Abstract
Surrogate endpoints are important for validation of mechanism, early proof of concept, and the rational design of clinical trials for regulatory approval of drugs. The recent failure of several drugs in peripheral arterial disease (PAD) and in atherosclerosis highlights the importance of understanding drug effect and is a clarion call for better endpoints. This review focuses on aspects relating to the current state of surrogate endpoints in PAD and reviews emerging endpoints using imaging approaches that may have the potential of improving study design in PAD.
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| http://dx.doi.org/10.1016/j.ccl.2011.04.002 | DOI Listing |
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