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ObvioHealth Develops Novel Digital Instruments to Reduce Subjectivity while Increasing Compliance in Pediatric Clinical Trials

The Virtual Research Organization’s new image and audio capture capabilities address common challenges for caregivers and their children as well as for clinicians.

NEW YORK, May 10, 2022 - ObvioHealth, a leading global Virtual Research Organization (VRO) pioneering end-to-end decentralized clinical trial solutions, announces the development of two novel digital instruments to increase accuracy and reduce patient/caregiver burden in pediatric clinical trials.  

A recent study published in Pediatrics reveals many pediatric trials don’t make it to completion. For studies that are completed, caregiver subjectivity can significantly skew reported outcomes. Both of these issues are the heart of ObvioHealth’s instrument innovation - designed to make data capture easier for caregivers and their children while facilitating the scoring of unstructured data by expert raters.

  • The pediatric GI instrument uses AI to guide caregivers through capturing high-quality, privacy-compliant photos of infant stool. This tool facilitates real-world gastrointestinal data capture just as rates of pediatric-onset Inflammatory Bowel Disease and other common gastrointestinal diseases are on the rise.  
  • The pediatric cry capture instrument enables effortless recording of crying episodes, collecting data such as duration, type, and/or sounds of crying. Parents and caregivers who tend to overestimate the duration of their kids' cries, struggle to collect accurate data.

 

Both tools include the option to send the captured data – whether image or audio – to the expert rater platform for scoring, streamlining the workflow for raters and alerting them to variability in their scores. In parallel, ObvioHealth is annotating scores and training algorithms through artificial intelligence with the goal of further assisting raters.  

“There is a penury of innovation in pediatric research, and it is hindering the industry’s ability to deliver meaningful trial outcomes,” said Ivan Jarry, CEO of ObvioHealth. “We’re deploying these digital tools to make clinical research easier for the sponsors as well as for the caregivers and their children and to ultimately provide kids with better therapeutics.”  

In addition to the tools referenced above, ObvioHealth is developing other novel digital instruments for use in an upcoming clinical trial. The impact of such instruments has potential beyond research to facilitate clinical practice.  

“There is a need for more reliable and consistent tools for evaluating symptomology in young children. Leveraging AI-driven technologies is an opportunity to reduce the burden and shortcomings of patient reporting,” said Jaya Punati, MD, a board-certified pediatric gastroenterologist at Children’s Hospital of Los Angeles who has co-authored pediatric GI-related research with ObvioHealth. “These instruments could help physicians by increasing the visibility of real-world symptoms that manifest outside of the office setting, enabling more accurate diagnoses and individualized care.”