Key Infrastructure Elements for Conducting Pediatric Medical Device Clinical Trials.

Abstract

BACKGROUND AND OBJECTIVES Pediatric medical device (PMD) development lags behind device development for adults. We sought to identify infrastructure elements that support the conduct of PMD clinical trials (PMD-CTs). METHODS We conducted a multistage modified Delphi process with 25 panelists who were experts on different aspects of PMD-CTs to identify and rate the importance of infrastructure elements and supporting activities. RESULTS The panelists identified and rated the importance of 24 activities and 130 infrastructure components for conducting PMD-CTs. The panelists gave the highest importance ratings to assuring compliance with US Food and Drug Administration regulations (mean score, 5.0; IQR, 5.0-5.0; range, 5.0-5.0) and data and safety monitoring (mean score, 4.9; IQR, 5.0-5.0; range, 4.0-5.0). The infrastructure components with the highest importance ratings were "Principal investigator with clinical experience" and "Device training plan" under the activity "Implant and use device." Although some activities and infrastructure components received low importance ratings from individual panelists, all received high ratings from most panelists. CONCLUSIONS Our panelists showed areas of agreement on what activities and infrastructure elements are important for conducting a successful PMD-CT, but panelists did not start with a common mental model of the tasks required for a PMD-CT, with some activities dismissed by a subset of panelists as unimportant or irrelevant. Lack of a shared mental model, differences in preferred terminology, and variability regarding the importance of key activities and infrastructure supports pose challenges for institutions and organizations attempting to support the development of PMDs.