Improving the Infrastructure for Pediatric Medical Device Trials at Children's Hospitals.

Abstract

The shortage of novel pediatric devices that accommodate the unique needs of children exists due to several scientific, clinical, regulatory, and financial barriers. This global unmet need is being addressed in the United States by multiple stakeholders including the Food and Drug Administration (FDA) and its Pediatric Device Consortia (PDC) grant program. One critical area of interest is the suboptimal medical device clinical trial infrastructure that currently exists in academic medical centers and compounded at children's hospitals. Although pediatric drug clinical trial infrastructure is often well developed at many children's hospitals, these capabilities do not necessarily translate to pediatric device trials. The chief challenge to address is the recognition of differences in conducting device vs drug trials. We need to shift the paradigm by introducing best practices and a set of tools and job aids to assist the stakeholders of device trials at children's hospitals. Pediatric medical device clinical trial support has unique infrastructure needs and barriers compared to trials carried out of adult medical devices and drugs. Well-coordinated cross-sector collaboration is needed to advance the state of pediatric medical devices. To assess these gaps and challenges, surveys and interviews were conducted with key leaders at each of the children's hospitals primarily associated with the 5 FDA-supported PDCs. Reviews of pediatric device clinical trials were performed at each institution with the goal of identifying the common denominators and specifics of best practices, challenges, and areas of improvement for conducting and supporting pediatric device trials.