Coran Philip, Goldsack Jennifer C, Grandinetti Cheryl A, Bakker Jessie P, Bolognese Marisa, Dorsey E Ray, Vasisht Kaveeta, Amdur Adam, Dell Christopher, Helfgott Jonathan, Kirchoff Matthew, Miller Christopher J, Narayan Ashish, Patel Dharmesh, Peterson Barry, Ramirez Ernesto, Schiller Drew, Switzer Thomas, Wing Liz, Forrest Annemarie, Doherty Aiden
Medidata Solutions, New York, New York, USA.
Clinical Trials Transformation Initiative, Durham, North Carolina, USA.
Digit Biomark. 2019 Nov 6;3(3):145-154. doi: 10.1159/000503957. eCollection 2019 Sep-Dec.
Mobile technologies offer the potential to reduce the costs of conducting clinical trials by collecting high-quality information on health outcomes in real-world settings that are relevant to patients and clinicians. However, widespread use of mobile technologies in clinical trials has been impeded by their perceived challenges. To advance solutions to these challenges, the Clinical Trials Transformation Initiative (CTTI) has issued best practices and realistic approaches that clinical trial sponsors can now use. These include CTTI recommendations on technology selection; data collection, analysis, and interpretation; data management; protocol design and execution; and US Food and Drug Administration submission and inspection. The scientific principles underpinning the clinical trials enterprise continue to apply to studies using mobile technologies. These recommendations provide a framework for including mobile technologies in clinical trials that can lead to more efficient assessment of new therapies for patients.
移动技术有潜力通过在与患者和临床医生相关的现实环境中收集有关健康结果的高质量信息，来降低开展临床试验的成本。然而，移动技术在临床试验中的广泛应用受到了人们所认为的挑战的阻碍。为了推进应对这些挑战的解决方案，临床试验转型倡议组织（CTTI）发布了临床试验申办者现在可以采用的最佳实践和切实可行的方法。这些包括CTTI关于技术选择、数据收集、分析和解释、数据管理、方案设计与执行，以及向美国食品药品监督管理局提交申请和接受检查等方面的建议。支撑临床试验事业的科学原则继续适用于使用移动技术的研究。这些建议为在临床试验中纳入移动技术提供了一个框架，从而能够更高效地评估针对患者的新疗法。
