Moon John T, Konstantinidis Menelaos, Song Nevon, Nezami Nariman, Majdalany Bill S, Herr Allen, Siskin Gary
Division of Interventional Radiology and Image-Guided Medicine, Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, GA, USA.
Division of Biostatistics, Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
J Clin Transl Sci. 2023 Feb 3;7(1):e67. doi: 10.1017/cts.2023.10. eCollection 2023.
The Food and Drug Administration (FDA) reviews safety, efficacy, and the quality of medical devices through its regulatory process. The FDA Safety and Innovation Act (FDASIA) of 2012 was aimed at accelerating the regulatory process for medical devices.
The purpose of our study was to (1) quantify characteristics of pivotal clinical trials (PCTs) supporting the premarket approval of endovascular medical devices and (2) analyze trends over the last two decades in light of the FDASIA.
We surveyed the study designs of endovascular devices with PCTs from the US FDA pre-market approval medical devices database. The effect of FDASIA on key design parameters (e.g., randomization, masking, and number of enrolled patients) was estimated using an interrupted time series analysis (segmented regression).
We identified 117 devices between 2000-2018. FDASIA was associated with a decrease in double blinding ( < 0.0001) and a decrease in historical comparators ( < 0.0001).
Our results reveal an overall trend of decreased regulatory requirements as it relates to clinical trial characteristics, but a compensatory increased rate of post-approval across device classes. Furthermore, there was an emphasis on proving equivalence or non-inferiority rather than more use of active comparators in clinical trials. Medical device stakeholders, notably clinicians, must be aware of the shifting regulatory landscape in order to play an active role in promoting patient safety.
美国食品药品监督管理局（FDA）通过其监管程序审查医疗器械的安全性、有效性和质量。2012年的《FDA安全与创新法案》（FDASIA）旨在加快医疗器械的监管程序。
我们研究的目的是（1）量化支持血管内医疗器械上市前批准的关键临床试验（PCT）的特征，以及（2）根据FDASIA分析过去二十年的趋势。
我们从美国FDA上市前批准医疗器械数据库中调查了具有PCT的血管内器械的研究设计。使用中断时间序列分析（分段回归）估计FDASIA对关键设计参数（如随机化、盲法和入组患者数量）的影响。
我们在2000 - 2018年间识别出117种器械。FDASIA与双盲法的减少（<0.0001）和历史对照的减少（<0.0001）相关。
我们的结果揭示了与临床试验特征相关的监管要求总体下降趋势，但各器械类别批准后的补偿性增加率有所上升。此外，临床试验中更强调证明等效性或非劣效性，而不是更多地使用活性对照。医疗器械利益相关者，尤其是临床医生，必须意识到不断变化的监管格局，以便在促进患者安全方面发挥积极作用。
