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Pediatric research: technical & logistical considerations - post natal ontogeny

Part 1 of 3
Published on May 28, 2026   21 min

A selection of talks on Methods

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0:00
Hello, this is Prof. Steven Hirschfeld of the Uniformed Services University of the Health Sciences, and I will be discussing pediatric research, technical, and logistical considerations in a three-part presentation. This is Part 1 on postnatal ontogeny.
0:21
The major points across all three of the presentations is that postnatal human ontogeny is dynamic and much more than size changes. Diseases of children are different at different ages or manifest differently than diseases seen in adults, and many diseases are relatively rare, resulting in design considerations. Extrapolation of adult data or other data to pediatric data can be useful in the right circumstances, and we will discuss how to apply extrapolation. Medicinal product regulatory programs around the world vary. The European Union and the United States of America have the most robust. But the whole process is coordinated by the International Conference on Harmonization. Finally, pediatric programs require planning, consultation, and collaboration with a properly trained staff and infrastructure.
1:25
The general scientific and ethical rationale for clinical research to evaluate an intervention is that the intervention is provided in the context of a protocol, the intervention is under evaluation with equipoise, participation is voluntary with documented permission, and we've discussed in an earlier talk about the variations on permission regarding the participation of children, the data will be pooled and analyzed systematically, the results will be disseminated, and a clinical trial process has greater stringency and oversight than standard healthcare delivery. Specific rationale for undertaking

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Pediatric research: technical & logistical considerations - post natal ontogeny

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