技术支持的临床试验:改变医学证据的产生
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在PubMed上查看摘要
概括
此摘要是机器生成的。整合电子健康记录,移动应用程序和可穿戴设备可以使临床试验更有效. 然而,克服实施挑战和建立监管框架对于采用这些创新技术至关重要.
科学领域
- 临床试验
- 卫生信息学
- 生物技术
背景情况
- 传统的随机对照试验面临越来越高的复杂性和成本, 阻碍了药物和设备的开发.
- 电子健康记录 (EHR),移动应用程序和可穿戴设备等新兴技术为提高临床试验效率和实用性提供了机会.
研究的目的
- 在临床试验中探索EHR,移动和可穿戴技术的应用.
- 确定这些技术如何简化试验执行并实现创新设计.
- 确定实施和最佳监管框架的障碍.
主要方法
- 在2018年10月召开多方利益相关者小组.
- 研究了新技术在临床试验中的应用.
- 评估了潜在的好处,实施障碍和监管需求.
主要成果
- 新技术为改变临床试验提供了巨大潜力.
- 简化试验组件和实现创新设计是关键的好处.
- 代实施,持续学习和试点研究是成功采用的必要条件.
结论
- 电子健康记录,移动和可穿戴技术的整合为改善临床试验提供了巨大的前景.
- 应对实施挑战和建立明确的监管途径至关重要.
- 建议采用基于学习的分阶段方法将这些进展纳入常规临床试验操作中.
相关概念视频
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