Rao Sunil V, Califf Robert M, Kramer Judith M, Peterson Eric D, Gross Thomas P, Pepine Carl J, Williams David O, Donohoe Dennis, Waksman Ron, Mehran Roxana, Krucoff Mitchell W
Duke Clinical Research Institute and Duke University Medical Center, Durham, NC 27705, USA.
Am Heart J. 2008 Aug;156(2):201-8. doi: 10.1016/j.ahj.2008.01.036.
Cardiovascular procedures performed in the United States have more than tripled in the last decade, a trend that is expected to continue with the aging of the population, coupled with epidemics of obesity and diabetes mellitus. Helping to drive this increase are new medical devices that address conditions previously treated by medication alone. Many of these novel devices receive expedited reviews before Food and Drug Administration (FDA) approval and are rapidly adopted into clinical practice. However, recent high-profile cases involving potentially dangerous defects in widely used medical devices have increased concerns about the adequacy of premarket trials and postmarket surveillance in establishing the safety of these devices. In response to these concerns, the American College of Cardiology and the Duke Clinical Research Institute sponsored a "think tank" of experts representing the industry, regulatory authorities, academic medicine, and professional societies to examine these concerns and propose possible solutions. This group examined case studies including drug-eluting stents and implantable cardioverter-defibrillators. Challenges inherent in the current system, including the difficulty of establishing accurate event rates for medical devices and potential disincentives for the industry to conduct comprehensive monitoring, were discussed. Possible solutions to these problems included improving and enforcing current regulations, considering creative study design strategies that link pre- and postmarket data, declaring postmarket surveillance a public health issue, creating financial incentives for participation in postmarketing studies, using more relevant animal models, encouraging postmortem device retrieval, and aligning professional societies with the FDA to evaluate breakthrough technologies and communicate findings to patients and clinicians.
在过去十年中，美国进行的心血管手术增加了两倍多，随着人口老龄化，再加上肥胖症和糖尿病的流行，这一趋势预计还将持续。推动这一增长的是一些新的医疗设备，它们可治疗以前仅靠药物治疗的疾病。其中许多新型设备在获得美国食品药品监督管理局（FDA）批准之前都经过了快速审查，并迅速应用于临床实践。然而，最近一些涉及广泛使用的医疗设备存在潜在危险缺陷的备受瞩目的案例，增加了人们对上市前试验和上市后监测在确定这些设备安全性方面是否充分的担忧。为回应这些担忧，美国心脏病学会和杜克临床研究所发起了一个由代表行业、监管机构、学术医学和专业协会的专家组成的“智囊团”，以研究这些担忧并提出可能的解决方案。该小组研究了包括药物洗脱支架和植入式心脏复律除颤器在内的案例研究。讨论了当前系统中固有的挑战，包括难以确定医疗设备的准确事件发生率以及行业进行全面监测的潜在阻碍。这些问题的可能解决方案包括改进和执行现行法规，考虑将上市前和上市后数据联系起来的创新研究设计策略，将上市后监测宣布为公共卫生问题，为参与上市后研究创造经济激励措施，使用更相关的动物模型，鼓励尸检时取出设备，以及使专业协会与FDA保持一致，以评估突破性技术并向患者和临床医生传达研究结果。
