Pediatric Digital Measurement in Clinical Development
As children are often unable to accurately communicate and report their symptoms, researchers often rely on behavior as a proxy. Unlike clinical trials in adults which rely on patient-reported outcome measures, pediatric trials frequently depend on caregiver reports and episodic observations that may miss some manifestations of disease. Caregivers are inherently limited in their ability to witness and identify events of interest in children. Performance outcomes can also have poor accuracy, subjectivity, and variability in this population as it is difficult to get children to follow directions and cooperate.
Just as a stadiometer would not be appropriate to measure height in infants, the digital tools and techniques we use to measure health and disease in children should be fit for purpose. Sensor technology is particularly well suited to measure difficult-to-capture signs and symptoms of disease, especially in pediatric sleep measurement when a caregiver may not be awake. In recent years we have seen several types of worn sensors (adhesive patch, wristwatch, clothing items [e.g., sock]) as well as videorecording and motion sensor (e.g., in-home wall or mattress, smartphone computer vision) technology be harnessed to monitor children. We have also seen the advent of virtual reality games (VRG) which have the potential to evaluate a child’s disease progression or the efficacy of a therapeutic agent, particularly in behavioral disorders.
In the third UCB Digital Health Roundtable, Emily Lewis (Digital Business Transformation, Neurology, UCB) convened an expert panel to discuss the field of pediatric digital measurement to unpack key learnings from deployments to date, challenges, opportunities and the need for its translation into care.
The expert speaker panel included: John Campbell (Head of Decentralized Trials, Walgreens), Dudley Tabakin, (Chief Executive Officer, Vivosense), Dr. Alisa Niksch (Senior Director, Medical Affairs, Owlet), Dr. Sylvain Zorman (Director of Digital Health Sciences, Actigraph).
To watch the live recording click here.