Decentralized Clinical Trials: The Future of Medical Product Development?∗.
Decentralized Clinical Trials: The Future of Medical Product Development?∗.
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DOI：
10.1016/j.jacbts.2021.01.011
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发表时间：
2021-04
期刊：
影响因子：
--
通讯作者：
Van Norman GA
中科院分区：
文献类型：
--
作者：
Van Norman GA
Covid-19 大流行扰乱了许多可能将新疗法推向市场的临床试验——由于向有需要的患者发布可能有益的疗法的延迟，大流行给生命和生活质量造成了额外的未计成本。大流行的另一个副作用是医生和患者之间迅速采用虚拟互动，以提供连续性护理，同时保持社交距离。这是在允许这些交互的技术快速进步的时代，例如增强的互联网连接、电子健康记录、实时视频会议、智能手机健康应用程序以及可远程连接的健康监测设备，这些设备变得更加准确、实用且价格实惠。随着人们对“虚拟医学”的接受，人们对使用此类“虚拟元素”的分散式临床试验 (DCT) 的兴趣也在增长，加速了许多人认为早就应该进行的临床试验设计的转变。DCT（也称为“直接面向参与者的试验”或“虚拟”研究）的特点是较少依赖传统研究设施或专业中介机构进行数据收集。 DCT 利用“虚拟”工具，例如远程医疗、基于传感的技术、可穿戴医疗设备、家访、患者驱动的虚拟医疗保健界面以及将研究药物和材料直接运送到患者家中。在完全分散的临床试验中，受试者招募、研究药物的递送和管理以及试验结果数据的获取都在不涉及研究团队和患者/受试者之间的面对面接触的情况下进行。
The Covid-19 pandemic disrupted many clinical trials that were potentially bringing new therapeutics to market—an additional untallied cost of the pandemic in lives and quality of life owing to delays in releasing potentially beneficial therapeutics to patients in need. A separate sideeffect of the pandemic has been swift adoption of virtual interactions between physicians and patients to provide continuity of care while maintaining social distancing. This comes at a time of rapid advancement of technology permitting those interactions, such as enhanced internet connectivity, electronic health records, real-time video conferencing, smartphone health applications, and remotely connectable health monitoring devices that are becoming both more accurate, practical, and affordable. Interest in decentralized clinical trials (DCTs) that use “virtual elements” like these has grown in parallel with acceptance of “virtual medicine,” accelerating shifts in clinical trial design that many feel are long overdue.DCTs—also termed “direct-to-participant trials” or “virtual” studies—are characterized by less dependence on traditional research facilities or specialist intermediaries for data collection. DCTs leverage “virtual” tools, such as telemedicine, sensory-based technologies, wearable medical devices, home visits, patient-driven virtual health care interfaces, and direct delivery of study drugs and materials to patients’ homes. In a fully decentralized clinical trial, subject recruitment, delivery and administration of study medication, and acquisition of trial outcomes data all proceed without involving in-person contact between the study team and the patient/subject.
影响因子：
2.2
作者：
Orri, Miguel;Lipset, Craig H.;Cummings, Steven R.
通讯作者：
Cummings, Steven R.