4.7 Review

A systematic review of feasibility studies promoting the use of mobile technologies in clinical research

Journal

NPJ DIGITAL MEDICINE
Volume 2, Issue -, Pages -

Publisher

NATURE RESEARCH
DOI: 10.1038/s41746-019-0125-x

Keywords

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Funding

  1. Food and Drug Administration [R18FD005292]
  2. CTTI's member organizations
  3. Harvard-MIT Center for Regulatory Science
  4. MRC [G0901530] Funding Source: UKRI

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Mobile technologies, such as smart phone applications, wearables, ingestibles, and implantables, are increasingly used in clinical research to capture study endpoints. On behalf of the Clinical Trials Transformation Initiative, we aimed to conduct a systematic scoping review and compile a database summarizing pilot studies addressing mobile technology sensor performance, algorithm development, software performance, and/or operational feasibility, in order to provide a resource for guiding decisions about which technology is most suitable for a particular trial. Our systematic search identified 275 publications meeting inclusion criteria. From these papers, we extracted data including the medical condition, concept of interest captured by the mobile technology, outcomes captured by the digital measurement, and details regarding the sensors, algorithms, and study sample. Sixty-seven percent of the technologies identified were wearable sensors, with the remainder including tablets, smartphones, implanted sensors, and cameras. We noted substantial variability in terms of reporting completeness and terminology used. The data have been compiled into an online database maintained by the Clinical Trials Transformation Initiative that can be filtered and searched electronically, enabling a user to find information most relevant to their work. Our long-term goal is to maintain and update the online database, in order to promote standardization of methods and reporting, encourage collaboration, and avoid redundant studies, thereby contributing to the design and implementation of efficient, high-quality trials.

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