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.

在本期JAMA Internal Medicine 中，Hey 及其同事¹解决了实验室或替代终点在关键临床试验中的最佳作用这一长期存在的问题。他们的研究引起了人们对美国食品和药物管理局 (FDA) 在应用这些终点时遵循自己的标准的程度的担忧。

临床试验对于开发新药以改善健康至关重要。多年来，人们一直在争论提高这项研究的效率、安全性和可重复性的最佳方法。尽管临床研究在所有疾病状态下都至关重要，但最近的注意力集中在对传染病新药的迫切需求上。对现有药物无反应的新传染源不断出现，例如人类免疫缺陷病毒 (HIV)、寨卡病毒和埃博拉病毒。常见的细菌病原体对现有治疗的抵抗力越来越强。因此，FDA 被迫加快其药物测试和批准程序。