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Activity Number:
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571
- Special Topics and Case Studies in Clinical Trials
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Type:
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Contributed
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Date/Time:
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Wednesday, July 31, 2019 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #304396
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Presentation
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Title:
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Assessing Similarity to Support Pediatric Extrapolation
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Author(s):
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Forrest Williamson*
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Companies:
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Eli Lilly
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Keywords:
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pedaitric;
extrapolation;
design;
E11(R1);
bayes;
robust
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Abstract:
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Pediatric extrapolation is defined in ICH E11(R1) as “an approach to providing evidence in support of effective and safe use of drugs in the pediatric population when it can be assumed that the course of the disease and the expected response to a medicinal product would be sufficiently similar in the pediatric and reference (adult or other pediatric) population.” The wording “expected response” can be interpreted to mean that a priori there is a scientific justification as to why the response should be similar between populations. This justification should always be provided as part of the rationale for the use of extrapolation. In practice, the scientific rationale may not be sufficient to make all parties comfortable with the extrapolation approach. In such situations it is not uncommon to make assessing similarity part of the extrapolation plan, meaning that extrapolation becomes dependent on proving similarity in response between populations after the pediatric trial is conducted. This talk highlights various ways to assess similarity between target and source populations for the purpose of pediatric extrapolation.
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Authors who are presenting talks have a * after their name.
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