Published April 22, 2025 | Version v1
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GLOPAD Paediatric Use Case: Important Considerations in Assessing the Population Representativeness of Paediatric Clinical Trials

Description

Randomized controlled trials remain the gold standards for generating new novel medical evidence. To be meaningful the evidence generated must be generalizable to the real-world population. The generalisability of a trial is partially determined by its population representativeness, which measures the coverage of the trial participants within the real-world patient population. This form of representativeness – referred to as aposteriori representativeness, has been evaluated for multiple trials (both individually and collectively) involving other patients. However, such analyses for paediatric trials are very limited. The goal of this Use Case was to review the important elements of paediatric clinical trial representativeness, identify paediatric-specific challenges and possibly come up with solutions to address these challenges.

 

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GLOPAD Use case Report.pdf

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Additional details

Funding

European Commission
c4c – conect4children (COllaborative Network for European Clinical Trials For Children) 777389