Hurst Frank P, Chianchiano Dolph, Upchurch Linda, Fisher Benjamin R, Flythe Jennifer E, Castillo Lee Celeste, Hill Terri, Neuland Carolyn Y
Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.
National Kidney Foundation, New York, NY.
Am J Kidney Dis. 2017 Oct;70(4):561-569. doi: 10.1053/j.ajkd.2017.03.013. Epub 2017 Apr 27.
New technologies challenge current dialysis treatment paradigms as devices become smaller, more portable, and increasingly used outside the dialysis clinic. It is unclear how patients will view this care transition, and it will be important to consider patient and care partner perspectives during all aspects of development for novel dialysis therapies, from design and clinical trials to regulatory approval. To gain insight into this area, the Kidney Health Initiative, a public-private partnership between the American Society of Nephrology, the US Food and Drug Administration, and nearly 80 member organizations and companies dedicated to enhancing patient safety and fostering innovation in kidney disease, convened a workshop of patients, care partners, and other kidney community stakeholders. The workshop included background presentations followed by focused small group discussions in 3 areas (device design, clinical trials, and regulatory approval). Participants explored how to involve patients throughout the life cycle of a medical device, including discussions of how patients can influence device design, assist in the planning and implementation of clinical trials, and provide input to affect regulatory decisions. Patients were engaged in the workshop discussion and interested in sharing their perspectives, but they recommended additional efforts around education, communication, and outreach in these areas.
随着设备变得更小、更便于携带且越来越多地在透析诊所之外使用，新技术对当前的透析治疗模式提出了挑战。目前尚不清楚患者将如何看待这种护理转变，并且在新型透析疗法开发的各个方面，从设计、临床试验到监管审批，考虑患者及护理伙伴的观点都将非常重要。为深入了解该领域，由美国肾脏病学会、美国食品药品监督管理局以及近80个致力于提高患者安全性和促进肾脏病创新的成员组织与公司组成的公私合作机构——肾脏健康倡议组织，召开了一次由患者、护理伙伴以及肾脏领域其他利益相关者参加的研讨会。该研讨会包括背景介绍，随后在三个领域（设备设计、临床试验和监管审批）进行了有针对性的小组讨论。参与者探讨了如何让患者参与医疗设备的整个生命周期，包括讨论患者如何影响设备设计、协助临床试验的规划与实施以及为影响监管决策提供意见。患者参与了研讨会讨论并乐于分享他们的观点，但他们建议在这些领域围绕教育、沟通和推广开展更多工作。
