In this issue of JAMA Internal Medicine, Hey and colleagues1 address the long-standing question of the optimum role of laboratory or surrogate end points in pivotal clinical trials. Their study raises concerns about how closely the US Food and Drug Administration (FDA) is following its own standards for applying these end points.
Clinical trials are essential for creating new drugs to improve health. The best means to improve the efficiency, safety, and reproducibility of this research has been debated for many years. Although clinical research is vital in all disease states, recent attention has focused on the urgent need for new drugs for infectious diseases. New infectious agents that are unresponsive to existing drugs continue to appear, such as human immunodeficiency virus (HIV), Zika, and Ebola. Common bacterial pathogens are increasingly resistant to available treatments. As a result, the FDA has been pressured to accelerate its drug testing and approval processes.
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Volberding P, Chambers HF. Antimicrobial Drug Development Efficiency and Surrogate Markers of Clinical Benefit. JAMA Intern Med. 2020;180(1):138–139. doi:10.1001/jamainternmed.2019.5441
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