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Key Infrastructure Elements for Conducting Pediatric Medical Device Clinical Trials
Chris Feudtner1,2, Douglas L Hill1, Russell T Nye1,3
1Division of General Pediatrics, The Children's Hospital of Philadelphia; Philadelphia, Pennsylvania.
Insights
Developing pediatric medical devices (PMDs) requires specific infrastructure. Experts identified key elements for successful pediatric medical device clinical trials (PMD-CTs), highlighting regulatory compliance and data monitoring as crucial.
Area of Science:
- Medical device development
- Clinical trial management
- Pediatric healthcare innovation
Background:
- Pediatric medical device (PMD) development significantly lags behind adult device development.
- There is a need to identify critical infrastructure supporting PMD clinical trials (PMD-CTs).
Purpose of the Study:
- To identify and rate the importance of infrastructure elements and supporting activities for PMD-CTs.
- To establish a consensus on essential components for successful PMD-CTs.
Main Methods:
- A multistage modified Delphi process was employed.
- Twenty-five experts in various aspects of PMD-CTs participated.
- Panelists identified and rated the importance of 24 activities and 130 infrastructure components.
Main Results:
- Highest importance was given to assuring US Food and Drug Administration (FDA) regulatory compliance and data and safety monitoring.
- Key infrastructure components included 'Principal investigator with clinical experience' and 'Device training plan'.
- Most identified activities and components received high importance ratings from the majority of panelists.
Conclusions:
- Agreement exists on important activities and infrastructure for PMD-CTs.
- A lack of a common mental model and terminology differences pose challenges.
- Addressing these challenges is crucial for organizations supporting PMD development.
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.
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