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mHealth & Wearables

Remote monitoring and leveraging wearable devices and sensors in clinical trials

Wearable devices and sensors offer great potential in the collection of richer data and insights to enhance our understanding of the effects of treatment. They enable the collection of objective measures of intervention effects both in-clinic and in remote free-living settings. However, implementing wearables and sensors brings new challenges to clinical trial conduct, data management, including digital endpoint validation and interpretation.

Our ICON Insights will help you to understand and successfully address the complexities of implementation of wearable devices in trial design, execution and reporting.

Whitepaper: Wearables and digital endpoint strategy and validation

Whitepaper: Wearables and digital endpoint strategy and validation

Although mHealth devices and sensors are continuing to evolve, and it is now possible to capture a vast array of physiological data, the operationalization of digital trial is not without challenges.

  • Develop a strategy to identify devices that are "fit for purpose"
  • The ICON framework for Digital Endpoint selection and validation to ensure the outcome measurement is robust, reliable, and interpretable
  • Address the key considerations that arise when using digital technology to support endpoint generation in clinical studies such as Device Selection, Endpoint Reliability and Sensitivity, Meaningful Change Thresholds, and Analysis Strategy and Interpretation
  • Use our checklists for device selection and data strategy
Read the whitepaper

Media articles on wearables, sensors and remote monitoring

The value of measuring sleep and activity in Alzheimer's disease trials.

The value of measuring sleep and activity in Alzheimer's disease trials.

Sleep quality and quantity have clinical relevance in Alzheimer's disease. Review the use of wearables in Alzheimer’s disease to provide objective measures of sleep and activity patterns that are not subject to patient recall bias.

mHealth and wearables blogs

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ICON's real world data (RWD) continues to drive healthcare and research discussions and decisions. Stay up to date with the latest information that regulators, payers and providers demand.

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