Planning for the Next Pandemic: Ethics and Innovation Today for Improved Clinical Trials Tomorrow.
Planning for the Next Pandemic: Ethics and Innovation Today for Improved Clinical Trials Tomorrow.
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DOI：
10.1080/19466315.2021.1918236
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发表时间：
2022
影响因子：
1.8
通讯作者：
Beckman, Robert A.
中科院分区：
文献类型：
--
作者：
McMillan, Gianna;Mayer, Cristiana;Tang, Rui;Liu, Yi;LaVange, Lisa;Antonijevic, Zoran;Beckman, Robert A.
冠状病毒大流行引起了公众对药物开发中进行有效科学临床研究所需步骤的关注。指导临床研究的传统伦理原则仍然是医生、患者、公共卫生官员、调查人员、药物开发人员和公众的指南针。加快提供安全有效的COVID-19治疗和疫苗的进程是道义上的当务之急。分阶段随机临床试验的监管体系与紧迫的公共卫生需求之间存在明显的冲突，需要以伦理科学的严谨性来利用创新。随着大流行的展开，我们反思了贝尔蒙特的自主、有益和公正原则，并说明了创新的临床试验设计在缓解大流行挑战方面的作用。我们的讨论强调了选定类型的创新试验设计，并将其与伦理参数和公共卫生效益相关联。提供了平台试验和其他创新设计的详细信息，如篮式和伞式试验、利用外部数据源的设计、多阶段无缝试验、大型试验之间预先计划的对照组数据共享，以及在单个试验和开发阶段之间更广泛协调的关联试验的高阶系统，最近在概念上引入了“PIPELINE”。
The coronavirus pandemic has brought public attention to the steps required to produce valid scientific clinical research in drug development. Traditional ethical principles that guide clinical research remain the guiding compass for physicians, patients, public health officials, investigators, drug developers and the public. Accelerating the process of delivering safe and effective treatments and vaccines against COVID-19 is a moral imperative. The apparent clash between the regulated system of phased randomized clinical trials and urgent public health need requires leveraging innovation with ethical scientific rigor. We reflect on the Belmont principles of autonomy, beneficence and justice as the pandemic unfolds, and illustrate the role of innovative clinical trial designs in alleviating pandemic challenges. Our discussion highlights selected types of innovative trial design and correlates them with ethical parameters and public health benefits. Details are provided for platform trials and other innovative designs such as basket and umbrella trials, designs leveraging external data sources, multi-stage seamless trials, preplanned control arm data sharing between larger trials, and higher order systems of linked trials coordinated more broadly between individual trials and phases of development, recently introduced conceptually as “PIPELINEs.”
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