Related Experiment Video
Updated: May 12, 2025
11:19
Guidelines for Elective Pediatric Fiberoptic Intubation
Published on: January 17, 2011
17.4K
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.
Pediatrics
|May 7, 2025
Summary
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.
More Related Videos
Related Concept Videos
01:16Clinical Trials
6.6K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
6.6K
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
106
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
106