Subjectivity is a stumbling block in pediatric drug research, according to ObvioHealth, which has developed tools to make studies involving kids more objective.
Pediatric drug research is a considerable challenge for the industry and—according to an analysis published in the March edition of the journal Pediatrics—the majority of studies involving children fail to complete.
Failure to recruit is the most common reason for study discontinuation, according to the study. However, the authors also cite poor data quality related to investigator subjectivity as another common reason why sponsors halt studies early.
To try and address this, ObvioHealth has developed artificial intelligence (AI) based technologies designed to take the subjectivity out of data collection and assessment in clinical trials involving children. The technologies, called the pediatric GI instrument and the pediatric cry capture instrument, are designed to make data capture easier for caregivers and children while facilitating the scoring of unstructured data by expert assessors.
As the name suggests, the GI instrument uses an artificial intelligence algorithm to help researchers capture high-quality, privacy-compliant photos of infant stool samples. Similarly, the cry capture instrument is used to record crying episodes, collecting duration data as well as information about the type of sounds or crying being made.
Such information is valuable, ObvioHealth says, because parents and caregivers tend to overestimate the duration of their kids' cries and struggle to collect accurate data. The two technologies are able to transmit captured data to a “rater platform,” which is designed to let experts assess data in an efficient, unbiased manner and to alert sponsors of assessor variability.
ObvioHealth CEO Ivan Jarry said the lack of innovation in pediatric research is hindering the industry’s ability to deliver meaningful trial outcomes.
“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," he said.