Pediatric Device Clinical Trials Activity: 1999-2022

Area of Science:

• Pediatric medical research
• Medical device development
• Clinical trial analysis

Background:

• Pediatric medical device (PMD) development is crucial for child health.
• Understanding trends in PMD clinical trials is essential for assessing research progress.
• Comparing PMD trials with drug and biologic trials provides valuable context.

Purpose of the Study:

• To assess the landscape of pediatric medical device development.
• To compare the initiation trends of PMD clinical trials with those of pediatric drug and biologic trials.
• To analyze these trends over a significant period (1999-2022).

Main Methods:

• Utilized www.clinicaltrials.gov to identify and quantify pediatric clinical trials.
• Categorized trials into PMD, drugs, and biologics.
• Assessed clinical specialties and institutions, including FDA Pediatric Device Consortia (PDC) affiliated children's hospitals and all US medical institutions for national comparison.

Main Results:

• A total of 243 PMD trials were identified at FDA-PDC institutions.
• PMD trial initiation significantly increased from 2014-2022 compared to 1999-2013 (P < .001).
• Pediatric drug and biologic trial initiation rates showed no significant change between these periods, nationally and at FDA-PDC institutions.

Conclusions:

• Pediatric drug and biologic clinical trial initiation remained stable between 1999 and 2022.
• A significant increase in new pediatric medical device trials was observed from 2014 to 2022.
• This upward trend in PMD trials was consistent across both FDA-PDC institutions and national data.