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Longitudinal Observational Data in a Paediatric Disease Registry

Statistical Consultancy Team

The use of population-based disease registries to support ongoing data collection for long-term safety and clinical outcomes is becoming increasingly common. Data collection methods within registries can vary in terms of completeness and quality. This particular example arose from support to a post-registration commitment for marketing authorisation of a paediatric drug and aims to provide some insight to the techniques and strategies used to monitor paediatric development (growth, sexual maturation) and clinical outcomes of varying severity. The challenges of accounting for irregular follow-up and associated biases are illustrated, and potential statistical solutions described. Recommendations for future reporting are presented as part of the conclusions. 

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Topics: Statistical Programming, Randomization, Paediatric Disease Registry

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