Propes Caleigh, Locke Trevan, Hendricks-Sturrup Rachele
Department of Health Policy and Management Johns Hopkins Bloomberg School of Public Health and the Berman Institute of Bioethics Baltimore Maryland USA.
Duke-Robert J. Margolis, MD, Institute for Health Policy, Duke University Washington DC USA.
Learn Health Syst. 2025 Mar 3;9(3):e10467. doi: 10.1002/lrh2.10467. eCollection 2025 Jul.
Point-of-care trials, an approach to trial design that assesses medical product effectiveness while fully integrating research and care, represent a promising opportunity to generate practically relevant evidence efficiently for priority disease areas. However, this approach presents unique considerations for appropriate and ethical informed consent. As point-of-care trials evolve, it will be important to examine informed consent through the lens of their supporting technology, of the clinicians who are responsible for administering it, and of their broader regulatory environment. Steps should be taken to establish ethical standards for point-of-care trials that reflect and serve the best interests of patients while reducing administrative burden and complexity. Our commentary describes, overall and through the use of real-world examples, how this work is vital to ensuring a modern clinical trial enterprise that is patient-centered and equips patients to make fully informed decisions about their health care.
即时护理试验是一种试验设计方法，在充分整合研究与护理的同时评估医疗产品的有效性，为重点疾病领域高效生成具有实际相关性的证据提供了一个充满希望的机会。然而，这种方法在适当和符合伦理的知情同意方面存在独特的考量。随着即时护理试验的发展，从其支持技术、负责实施知情同意的临床医生以及更广泛的监管环境等角度审视知情同意将变得至关重要。应采取措施为即时护理试验建立伦理标准，既要反映并服务于患者的最佳利益，又要减轻行政负担和复杂性。我们的评论通过整体阐述并结合实际案例，说明了这项工作对于确保以患者为中心的现代临床试验体系至关重要，该体系能使患者有能力就自身医疗保健做出充分知情的决策。
