The Potential to Leverage Real-World Data for Pediatric Clinical Trials: A Proof-of-Concept Study

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Pediatric clinical research, especially in rare diseases, faces persistent challenges including the identification and recruitment of eligible patients, assessing protocol feasibility, and ensuring efficient trial execution. These issues are compounded by small, age-stratified populations and fragmented clinical data. Real-world data (RWD), especially when drawn from electronic health records (EHRs), present an opportunity to support innovative…

GLOPAD Paediatric Use Case: Important Considerations in Assessing the Population Representativeness of Paediatric Clinical Trials

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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.