The advances in minimally invasive lung cancer diagnostics of the last decade have transformed patient care but have also raised important concerns about the regulatory processes used to approve new devices and the best way to generate data to support their use. Disruptive technologies, such as robotic bronchoscopy, have been widely adopted by interventional pulmonologists in the absence of robust data demonstrating improved patient outcomes. Comparative research is needed to inform patient care, but traditional methods of conducting clinical trials in which research teams operate separately from clinical teams are ill-suited to testing the safety and effectiveness of technologies being introduced on the market at unprecedented speed. Pragmatic clinical trials, which integrate trial procedures into routine clinical care, represent an appealing alternative approach for generating much-needed data to inform clinical care. In this manuscript we illustrate the advantages and disadvantages of these research paradigms using two recently completed randomized controlled trials in navigational bronchoscopy and highlight the barriers and facilitators to using pragmatic trials to address the gap in comparative effectiveness research: these include the need for increased clarity of research regulations for pragmatic trials, adequate federal and private funding for such research, and alignment of incentives between clinicians, researchers, regulators, and industry.

中文翻译：

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跟上技术创新：介入肺病学实用临床试验的道德要求。


过去十年微创肺癌诊断的进步改变了患者护理，但也引发了对用于批准新设备的监管程序以及生成数据以支持其使用的最佳方式的重要担忧。在缺乏可靠数据证明患者预后改善的情况下，机器人支气管镜检查等颠覆性技术已被介入肺科医生广泛采用。需要比较研究来为患者护理提供信息，但研究团队与临床团队分开运作的传统临床试验方法不适合测试以前所未有的速度推向市场的技术的安全性和有效性。实用的临床试验将试验程序整合到常规临床护理中，代表了一种有吸引力的替代方法，可以生成急需的数据来为临床护理提供信息。在这份手稿中，我们使用最近完成的两项导航支气管镜随机对照试验来说明这些研究范式的优缺点，并强调了使用实用试验来解决比较有效性研究差距的障碍和促进因素：其中包括需要提高实用试验研究法规的清晰度，为此类研究提供足够的联邦和私人资金， 以及临床医生、研究人员、监管机构和行业之间的激励措施保持一致。