Activity Number:
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441
- Bayesian (and Other) Clinical Trials Designs
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Type:
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Contributed
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Date/Time:
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Thursday, August 12, 2021 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #318309
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Title:
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Pediatric Trial with Partial Extrapolation
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Author(s):
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Madhuja Mallick*
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Companies:
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Abbvie
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Keywords:
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Abstract:
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Enrollment is often challenging in pediatric trials. Low prevalence and other reasons make it difficult to have adequately powered confirmatory trials in pediatric populations. Prolonged enrollment time in a pediatric trial risks that the patient population may change over time. Extrapolation of efficacy data for a Phase 3 pediatric study based on existing adult and pediatric studies can be one of the options. There are several advantages if adult data can be extrapolated for a pediatric population. Extrapolation can reduce complexities of pediatric trials, limit exposure of children, and obtain results more quickly to increase access to effective medications. Extrapolation can be performed by borrowing or utilizing existing information from adult and pediatric trials. This presentation will discuss the possible extrapolation frameworks when there are uncertainties in disease progression and/or treatment exposure relationship between adult and pediatric patients.
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Authors who are presenting talks have a * after their name.
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