Takeda Pharmaceuticals International Co., Cambridge, Massachusetts, USA.
Clin Pharmacol Ther. 2018 Jul;104(1):42-52. doi: 10.1002/cpt.966. Epub 2018 Apr 2.
The development of innovative wearable technologies has raised great interest in new means of data collection in healthcare and biopharmaceutical research and development. Multiple applications for wearables have been identified in a number of therapeutic areas; however, researchers face many challenges in the clinic, including scientific methodology as well as regulatory, legal, and operational hurdles. To facilitate further evaluation and adoption of these technologies, we highlight methodological and logistical considerations for implementation in clinical trials, including key elements of analytical and clinical validation in the specific context of use (COU). Additionally, we provide an assessment of the maturity of the field and successful examples of recent clinical experiments.
创新性可穿戴技术的发展引起了人们对医疗保健和生物制药研发中数据收集新方法的极大兴趣。可穿戴设备在许多治疗领域都有多种应用；然而，研究人员在临床实践中面临许多挑战，包括科学方法以及监管、法律和运营方面的障碍。为了促进这些技术的进一步评估和采用，我们强调了在临床试验中实施的方法学和后勤方面的考虑因素，包括在特定使用情况下（COU）分析和临床验证的关键要素。此外，我们还评估了该领域的成熟度，并提供了最近临床试验的成功案例。
