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      The Digitization and Decentralization of Clinical Trials.

      1 , 2 , 3
      Mayo Clinic proceedings
      Elsevier BV

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          Abstract

          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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          Author and article information

          Journal
          Mayo Clin Proc
          Mayo Clinic proceedings
          Elsevier BV
          1942-5546
          0025-6196
          Oct 2023
          : 98
          : 10
          Affiliations
          [1 ] Department of Internal Medicine, Mayo Clinic School of Graduate Medical Education, Mayo Clinic, Rochester, MN, USA; Department of Cardiovascular Medicine, Mayo Clinic College of Medicine, Mayo Clinic, Rochester, MN, USA. Electronic address: Harmon.david@mayo.edu.
          [2 ] Department of Cardiovascular Medicine, Mayo Clinic College of Medicine, Mayo Clinic, Rochester, MN, USA.
          [3 ] Department of Cardiovascular Medicine, Mayo Clinic College of Medicine, Mayo Clinic, Rochester, MN, USA; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.
          Article
          S0025-6196(22)00560-2
          10.1016/j.mayocp.2022.10.001
          36669937
          5cbf0d90-e119-4f37-b0d6-1c37cb38e80e
          History

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