Pediatric Device Clinical Trials Activity Compared to Drugs and Biologics Trials 1999-2022

Abstract Objective This study assessed the state of PMD development by comparing PMD clinical trials to pediatric trials evaluating drugs and biologics, from 1999-2022. We hypothesized changes in numbers and types of PMD trials compared to drugs and biologics represent an indicator of PMD growth. Study Design www.clinicaltrials.gov was used to identify and quantify both PMD clinical trials and pediatric trials for drugs and biologics. Clinical specialty was also assessed. The institutions included were the seven children’s hospitals primarily affiliated with the FDA PDC grants program between 2018-2023. Results 243 PMD clinical trials were identified based on the year of initiation. The average number of PMD trials initiated per year per institution was 1.5. PMD trials significantly increased (p=0.0083) from 2014 onward compared to pediatric clinical trials for drugs and biologics, which demonstrated no significant change in trial initiation activity. A more than five-fold increase in PMD trials was observed from 2014-2018 compared to previous time periods, and there were 48% more PMD trials from 2019-2022 compared to 2014-2018. PMD trials represented 5% of clinical trials at the institutions studied. Conclusions While clinical trial activity for drug and biologic development remained stable from 1999-2022, initiation of PMD trials significantly increased. The present results suggest that clinical trials growth reflects increased PMD development. Accommodation and promotion of PMD clinical trial activity, which is still relatively small, by relevant programs and policies at the institutional and government levels may foster the advancement of PMD to further address unmet needs. Article Summary This article is an analysis of device trials performed at seven children’s hospitals affiliated with the FDA Consortia grants program between 1999 and 2022. What’s Known on This Subject There have been no prior studies of device trial activity at a cohort of children’s hospitals at academic medical centers. Over the past decade, FDA programs have been initiated to assist stakeholders in advancing the development of pediatric medical devices. What This Study Adds Pediatric device trials account for only 5% of total trials at the institutions studied. Of note, only half of these PMD trials (2.4% of total clinical trials) were sponsored by industry and likely seeking pediatric labeling.