Wearables And Quality Assurance In A Clinical Trial Setting
By Phillip Doyle, J.D., Ll.M. Executive Vice President, Head Of Global Quality, Worldwide Clinical Trials
For sponsors and trialists alike, the idea of wearable devices that could remotely, accurately, and constantly monitor a patient’s heartbeat, lung capacity, movement, and more (the list of potential targets grows longer every day) during the course of a clinical trial is breathtaking. It could change the dynamics of a trial in innumerable ways, enabling participants to travel less, while simultaneously ensuring quality and consistency of data collection, enabling real-time monitoring for adverse events even when participants are not at a trial site, streamlining incorporation of clinical data into the trial master file, and more. Additionally, wearables can lead to the creation of vast data sets that may lead to new insights about how a patient feels or functions and about the impact of innovative therapies on healthcare utilization.1-17
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