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W 45: Real-Time Monitoring of the Digital Patient in Clinical Trials





Poster Presenter

      Gregory Zak

      • Director, eCI Sales
      • ERT
        United States

Objectives

Wearable technology is a key component in the design of more patient-centric clinical trials, and this poster reports the real-time monitoring of subjects using wearable and patient-centric devices from multiple vendors.

Method

Wearable and patient-centric mobile technologies from multiple vendors were used to collect typical clinical outcome measures from healthy volunteer subjects. The data were integrated into an informatics hub using a digital health platform vendor for central analysis alongside subject variables. Co-authors Marie McCarthy, MSC, MBA, Director, Product Innovation, ICON Louis Smith, BAI, MSc, Data Science Manager, ICON Willie Muehlhausen, DVM, VP Head of Innovation, ICON

Results

Wearables and sensors are now commonplace, with 70% of consumers aware of wearable technology and 1 in 6 owning a device. Most of these devices sync with mobile phone apps, which in turn upload the data automatically to the cloud. The need for patients to travel long distances to attend site visits can be replaced by a “virtual site visit" in the patient's home. We have shown how the virtual site visit can even be continuous, delivering clinically relevant data that track safety and protocol compliance in real time. The implementation of this innovative approach requires careful consideration and planning, not only in terms of the selection of suitable, FDA-approved devices but also with respect to data management and analysis. We used some commercially available, validated devices to collect data from volunteer subjects, who synced their data with an associated vendor app on their phones. We then provisioned each user using a unique and secure token in a digital health platform vendor, allowing them to authorize the transfer of their data from the primary vendor. We built a custom integration tool to pull the data from the digital health platform API into our own informatics hub, where we integrated the data with solutions for risk-based monitoring, safety monitoring, protocol compliance and subject engagement. All data held in the cloud were completely non-identifiable, but we were able to re-identify the data once they arrived in our local and secure informatics hub.

Conclusion

The sustainability of the current drug development model is under serious scrutiny, with increasing costs, time to market and complexity and a requirement by payers and regulators for more real world data. One of the biggest factors impacting drug development is patient recruitment and retention. A new and innovative approach to conducting clinical trials is needed, and we have shown how patients can be enabled to measure clinical outcomes objectively and remotely while going about their daily lives. To obtain all the outcome measures required by a protocol, multiple devices may be needed, and we have shown how that can be achieved, while retaining full data privacy and security. Data collection without integration has a limited usefulness, so it was important to show how de-identified data collected through mobile devices can be (re)-integrated with the full set of clinical data on the patient in a secure environment in real time. We think there is huge potential in this approach to transform the way we monitor clinical trials and improve the quality of patient data. Data collected in this way are more objective and have a more transparent audit trail than more traditional clinical outcome assessment instruments.