Module232025

12/05/2025

Guidelines for Conducting Paediatric clinical Trials

• ICH E11: Clinical Investigation of Medicinal Products in the Paediatric Population (2000) • ICH E11(R1) Addendum to above (August 2017) • ICH E11A Paediatric Extrapolation • Provide an outline of the critical issues in drug development for paeds • Discuss approaches to the safe, efficient and ethical study of medicinal products in paeds • http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

The Organisation for Professionals in Regulatory Affairs

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Designing Clinical Trials

• Where is the patient population (NB expectation is that research will be conducted in patients only) • Are regulators, sponsors, investigators realistic • How many patients are required • How many will agree to participate • How many will meet protocol criteria • How many will complete • Can adaptive study designs be used to reduce patient numbers

The Organisation for Professionals in Regulatory Affairs

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