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在临床试验中使用电子技术。

Using e-technologies in clinical trials.

作者信息

Rosa Carmen, Campbell Aimee N C, Miele Gloria M, Brunner Meg, Winstanley Erin L

机构信息

National Institutes of Health, National Institute on Drug Abuse, Bethesda, MD, USA.

New York State Psychiatric Institute, Department of Psychiatry, Columbia University Medical Center, New York, NY, USA; Mount Sinai St. Luke's Hospital Department of Psychiatry and Behavioral Health, New York, NY, USA.

出版信息

Contemp Clin Trials. 2015 Nov;45(Pt A):41-54. doi: 10.1016/j.cct.2015.07.007. Epub 2015 Jul 12.

Abstract

Clinical trials have been slow to incorporate e-technology (digital and electronic technology that utilizes mobile devices or the Internet) into the design and execution of studies. In the meantime, individuals and corporations are relying more on electronic platforms and most have incorporated such technology into their daily lives. This paper provides a general overview of the use of e-technologies in clinical trials research, specifically within the last decade, marked by rapid growth of mobile and Internet-based tools. Benefits of and challenges to the use of e-technologies in data collection, recruitment and retention, delivery of interventions, and dissemination are provided, as well as a description of the current status of regulatory oversight of e-technologies in clinical trials research. As an example of ways in which e-technologies can be used for intervention delivery, a summary of e-technologies for treatment of substance use disorders is presented. Using e-technologies to design and implement clinical trials has the potential to reach a wide audience, making trials more efficient while also reducing costs; however, researchers should be cautious when adopting these tools given the many challenges in using new technologies, as well as threats to participant privacy/confidentiality. Challenges of using e-technologies can be overcome with careful planning, useful partnerships, and forethought. The role of web- and smartphone-based applications is expanding, and the increasing use of those platforms by scientists and the public alike make them tools that cannot be ignored.

摘要

临床试验在将电子技术(利用移动设备或互联网的数字和电子技术)纳入研究设计和实施方面进展缓慢。与此同时,个人和企业越来越依赖电子平台,大多数人已将此类技术融入日常生活。本文概述了电子技术在临床试验研究中的应用,特别是在过去十年中,这一时期以基于移动和互联网的工具的快速发展为标志。文中阐述了电子技术在数据收集、招募与留存、干预措施实施以及传播方面的益处和挑战,还描述了临床试验研究中电子技术监管监督的现状。作为电子技术可用于实施干预措施的一个示例,本文介绍了用于治疗物质使用障碍的电子技术总结。利用电子技术设计和开展临床试验有可能惠及广泛人群,使试验更高效且降低成本;然而,鉴于使用新技术存在诸多挑战以及对参与者隐私/保密性的威胁,研究人员在采用这些工具时应谨慎行事。通过精心规划、有益的合作关系和预先考虑,可以克服使用电子技术的挑战。基于网络和智能手机的应用程序的作用正在扩大,科学家和公众对这些平台的使用日益增加,使其成为不可忽视的工具。

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