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Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative
Digital Biomarkers Pub Date : 2019-11-06 , DOI: 10.1159/000503957
Philip Coran 1 , Jennifer C Goldsack 2, 3 , Cheryl A Grandinetti 4 , Jessie P Bakker 5 , Marisa Bolognese 6 , E Ray Dorsey 7 , Kaveeta Vasisht 4 , Adam Amdur 8 , Christopher Dell 9 , Jonathan Helfgott 10 , Matthew Kirchoff 11 , Christopher J Miller 12 , Ashish Narayan 13 , Dharmesh Patel 14 , Barry Peterson 15 , Ernesto Ramirez 16 , Drew Schiller 17 , Thomas Switzer 18 , Liz Wing 19 , Annemarie Forrest 2 , Aiden Doherty 20, 21
Affiliation  

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.

中文翻译:

在临床试验中推进移动技术的使用:来自临床试验转型计划的建议

移动技术通过收集与患者和临床医生相关的现实环境中健康结果的高质量信息,提供了降低临床试验成本的潜力。然而,移动技术在临床试验中的广泛使用受到其感知挑战的阻碍。为了推进应对这些挑战的解决方案,临床试验转型计划 (CTTI) 发布了临床试验申办者现在可以使用的最佳实践和现实方法。其中包括 CTTI 关于技术选择的建议;数据收集、分析和解释;数据管理; 协议设计和执行;和美国食品和药物管理局提交和检查。支撑临床试验企业的科学原则继续适用于使用移动技术的研究。这些建议为将移动技术纳入临床试验提供了一个框架,可以更有效地评估患者的新疗法。
更新日期:2019-11-06
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