Vanke School of Public Health, Tsinghua University, Beijing, China; Institute for Healthy China, Tsinghua University, Beijing, China.
Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Cancer Cell. 2024 Nov 11;42(11):1799-1802. doi: 10.1016/j.ccell.2024.09.005. Epub 2024 Oct 10.
We compare the clinical trial success rates of products receiving US Food and Drug Administration (FDA) accelerated approval (AA) to those approved without using this pathway. Our findings raise important questions about how the AA pathway can best optimize early access to therapeutics that are ultimately proven safe and effective.
我们比较了获得美国食品和药物管理局（FDA）加速批准（AA）的产品与未使用该途径获得批准的产品的临床试验成功率。我们的研究结果提出了一些重要的问题，即 AA 途径如何才能最好地优化早期获得最终被证明安全有效的治疗方法的机会。
