Module232025

12/05/2025

PIP life cycle experience – oncology experience

• PIP starts conservative (numbers of patients, design…) but adapts to evidence evolution over time via modifications • Median Time of approval 5.5y , predominately driven by adult efforts with use of extrapolation data • PIPs facilitate early(ier) (conditional) approvals : ongoing PIP studies (such as formulation development) used as post-marketing requirements (with PIP still ongoing) • File for an indication when enough data are available for that indication ( even if the whole PIP is not complete ) – PIP life-cycle approach!

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https://www.sciencedirect.com/science/article/pii/S2772610X24000503

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Paediatric Clinical Trials

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