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Paediatric Clinical Trial Planning:

  • Overall clinical approach

  • Critical aspects of study design

    • Optimized sample sizes

    • Age appropriate endpoints

  • Possible extrapolations from adult's data

  • Ethical issues for this vulnerable patient group

These issues are implemented in the Paediatric Investigational Plan [PIP] by PaediaCRO's standardized scientific methods leading to feasible paediatric clinical trial completion.