Biomarkers as surrogate end points in heart failure trials.
Despite the continued growth of heart failure as a major public health problem, the development of new therapies for heart failure has slowed and recent studies have been neutral, suggesting the need for a reappraisal of the clinical research enterprise. Surrogate end points, defined as measurements that are used as substitutes for the more clinically meaningful end points, can play a valuable role in clinical trials by accelerating the timeline for determining appropriate dosages, efficacy, and safety. Biomarkers, such as the natriuretic peptides, have many of the characteristics of valid surrogates but have not been sufficiently validated for widespread use. Ongoing research into the role of biomarkers as surrogates may lead to better clinical trial design and more efficient development of new therapies for heart failure.
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