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Pediatric research: technical & logistical considerations - study design and extrapolation

Part 3 of 3
Published on May 28, 2026   20 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 in Bethesda, Maryland. This is Part 3 of a three-part series on pediatric research technical and logistical considerations and we'll discuss study design and extrapolation.
0:21
I'll begin by noting the need for specialized concepts and terminology to obtain the necessary precision. As in Part 2, we discussed that the diseases can vary based on chronological age and developmental stage and that diseases that are seen across many ages, including adult diseases, can manifest differently in children. The concepts and terminology can be found in several locations and I reference too here, the Clinical Data Interchange Standards Consortium, which has a pediatric working group with terminology and the very comprehensive and well-organized National Cancer Institute Enterprise Vocabulary Services are both major resources to assist in the proper construction of pediatric research studies.
1:17
Pediatric conditions in general are relatively rare in that they meet the European Medicines Agency or the Food and Drug Administration's definition of rare disease. A few pediatric diseases are exceptions. These are typically infections, allergic conditions, inflammatory conditions, and they can affect hundreds of thousands to millions of children. Many of these diseases are preventable through vaccination. There are also some chronic diseases which are increasing in prevalence, such as asthma, obesity, attention deficit hyperactivity disorder, and type 1 diabetes mellitus. However, it is important to examine the epidemiology, incidence and prevalence of any pediatric disease with the expectation that most will qualify as orphan diseases.

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