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New CTTI Article Investigates Mobile Device Use to Measure Outcomes in Clinical Research

A CTTI article recently published in Digital Biomarkers investigates the use of mobile devices to measure outcomes in clinical research from 2010-2016. The article provides a detailed accounting of where the field is currently, allowing researchers to see what measures exist for using or developing technology-derived endpoints, how they are being used, and how to access relevant literature.

The review found that, while mobile devices are widely used to assess outcomes in observational research, their use in interventional research is limited. Additionally, the absence of standardization across the measures used to assess outcomes of interest, units of measurement, sampling rate, device placement, and the technologies themselves indicates a pressing need for standards to interpret and compare results across studies and across therapeutic areas.

The article offers suggestions for incorporating mobile technology into interventional research—such as consolidating evidence supporting the clinical meaningfulness of specific technology-derived endpoints, and standardizing the use of mobile devices in clinical research to measure these endpoints.

The review also found that:

  • The majority of technology-derived novel endpoints are currently being used in cardiac studies. However, in randomized controlled trials, technology-derived novel endpoints are most commonly used in Type I diabetes studies.
  • Physical activity measures are the most commonly used technology-derived endpoints in clinical studies. Other commonly used endpoints are related to sleep, mobility, and pill adherence, as well as biomarkers such as cardiac, glucose, gastric reflux, respiratory measures, and intensity of head-related injury.
  • There is a scarcity of technology-derived measures being used as actual outcome assessments in studies of neurological diseases such as Parkinson’s and Alzheimer’s, which have a considerable unmet need for measures. Oncology and nephrology are two other key therapeutic areas with unmet need for better assessments, but a dearth of technology-derived measures.