Marie McCarthy

Presentation Title:

What are the barriers to using Wearable in Clinical Trials?

Presentation Synopsis:

There has been a veritable explosion of consumer wearables, with devices now available that can measure anything from activity levels to oxygen saturation. It is a rapidly evolving sector resulting in miniaturized sensors and health platforms leading to the concept of the quantified self. Within the context of Clinical Trials, wearables have the potential to radically improve our understanding of treatment efficacy and safety with very low patient burden.

However this is a new paradigm, which opens up many as yet unanswered questions. In particular, the suitability of these wearables to collect clinical grade data in uncontrolled environments, and the development of suitable ecosystems that will allow the transfer of this data in a secure and compliant manner. This presentation will examine the factors ICON has taken into consideration when operationalising wearables in clinical trials.

Speaker Bio:

Marie joined ICON in 2014 as Director, Product Innovation. As part of a multidisciplinary innovation team, Marie has specific responsibility for developing solutions in the direct to patient paradigm, including the operationalization of wearable devices. She has coordinated projects to collect data generated from wearable devices into EDC and ICON’s proprietary data analytics solution, ICONIK. Marie acts in an advisory capacity for a number of sponsors on the relevant clinical endpoints and considerations to be deployed when embarking on the incorporation of wearable technology into clinical trials. As part of the ICON CNS innovation group she provides insight into outcomes addressed by wearable technology.