TY - JOUR
T1 - The Digitization and Decentralization of Clinical Trials
AU - Harmon, David M.
AU - Noseworthy, Peter A.
AU - Yao, Xiaoxi
N1 - Publisher Copyright:
© 2022 Mayo Foundation for Medical Education and Research
PY - 2023/10
Y1 - 2023/10
N2 - Now, more than ever, digital technology has made its way into the daily lives of billions across the globe, and the widespread use of this technology has also allowed a digital window into consumers’ and patients’ daily lives, respectively. In a similar way, the practice of medicine has digitally evolved with the application of electronic health records and development of wearable/portable consumer-based medical devices (eg, Apple Watch ECG and Kardia Mobile by AliveCor). Alongside the increased use of digital technology in clinical care (eg, telehealth and wearable arrhythmia detection), clinical investigators have harnessed this powerful stockpile of data to gain insight into what happens to patients beyond the clinic walls. In this thematic review, we show the impact of digital advancements on the clinical trial process from recruitment and enrollment to interventions and data collection. We also show the pragmatism of this decentralized process and how it will mitigate the limitations of conventional randomized controlled trials. Finally, while pushing the boundaries of tech, we also describe a few limitations of this rapidly growing field to understand better what gaps need to be bridged in the future.
AB - Now, more than ever, digital technology has made its way into the daily lives of billions across the globe, and the widespread use of this technology has also allowed a digital window into consumers’ and patients’ daily lives, respectively. In a similar way, the practice of medicine has digitally evolved with the application of electronic health records and development of wearable/portable consumer-based medical devices (eg, Apple Watch ECG and Kardia Mobile by AliveCor). Alongside the increased use of digital technology in clinical care (eg, telehealth and wearable arrhythmia detection), clinical investigators have harnessed this powerful stockpile of data to gain insight into what happens to patients beyond the clinic walls. In this thematic review, we show the impact of digital advancements on the clinical trial process from recruitment and enrollment to interventions and data collection. We also show the pragmatism of this decentralized process and how it will mitigate the limitations of conventional randomized controlled trials. Finally, while pushing the boundaries of tech, we also describe a few limitations of this rapidly growing field to understand better what gaps need to be bridged in the future.
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U2 - 10.1016/j.mayocp.2022.10.001
DO - 10.1016/j.mayocp.2022.10.001
M3 - Review article
C2 - 36669937
AN - SCOPUS:85149616589
SN - 0025-6196
VL - 98
SP - 1568
EP - 1578
JO - Mayo Clinic proceedings
JF - Mayo Clinic proceedings
IS - 10
ER -