Key Infrastructure Elements for Conducting Pediatric Medical Device Clinical Trials
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.
Authors
- Lynn A. Sleeper (ORCID: https://orcid.org/0000-0002-8055-768X)
- Douglas L. Hill (ORCID: https://orcid.org/0000-0003-3128-3384)
- Russell T. Nye (ORCID: https://orcid.org/0000-0003-4575-196X)
- Chris Feudtner (ORCID: https://orcid.org/0000-0002-5879-0434)
- Harvey S. Borovetz (ORCID: https://orcid.org/0000-0002-4677-6731)
- Joshua Dienstman
- Robert J. Levy (ORCID: https://orcid.org/0000-0002-0076-2780)
- Ashley Magnavita
- Stanley J. Stachelek
Institutions
- Boston Children's Hospital (US)
- Children's Hospital of Philadelphia (US)
- Harvard University (US)
- University of Pittsburgh (US)
- University of Pennsylvania (US)
Publication Details
- Journal
- PEDIATRICS
- Published
- 2025-05-07
- DOI
- https://doi.org/10.1542/peds.2024-069842
- Primary Topic
- Delphi Technique in Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00