Module232025

09/05/2025

Integration of evidence

1. Describe assumptions made, detail any gaps in knowledge, and assess the impact of uncertainties in the available evidence. 2. Review, synthesis, and presentation of information that should be included in a pediatric extrapolation concept • What is the body of evidence and what is the clinical relevance of the evidence? • What are the strengths and the limitations of the evidence? • How consistent are the findings across the sources and types of data? • What inconsistencies exist in the data and how do these inconsistencies affect assessment of similarity?

The Organisation for Professionals in Regulatory Affairs

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Rationale for extrapolation

1. Avoid “unnecessary” studies • Ethics • Efficiency

• Resource allocation – focus on areas where studies are most needed • Extrapolation is welcomed as a means to save patients and resources (i.e. target research where mostly needed), of special importance in PIPs 2. Feasibility restrictions • Apply extrapolation principles for rational interpretation of limited evidence in the context of data available from other sources

M&S can be used as platform to facilitate extrapolation

The Organisation for Professionals in Regulatory Affairs

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