Adaptive population enrichment designs
Duration: 40 mins 56 secs
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About this item
| Description: |
Dragalin, V (Johnson & Johnson PRD)
Monday 6th July 2015, 15:30 - 16:15 |
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| Created: | 2015-07-08 15:55 |
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| Collection: | Design and Analysis of Experiments |
| Publisher: | Isaac Newton Institute |
| Copyright: | Dragalin, V |
| Language: | eng (English) |
| Abstract: | There is a growing interest among regulators and sponsors in using precision medicine approaches that allow for targeted patients to receive maximum benefit from the correct dose of a specific drug. Population enrichment designs offer a specific adaptive trial methodology to study the effect of experimental treatments in various sub-populations of patients under investigation. Instead of limiting the enrolment only to the enriched population, these designs enable the data-driven selection of one or more pre-specified subpopulations at an interim analysis and the confirmatory proof of efficacy in the selected subset at the end of the trial. In this presentation, the general methodology and designing issues when planning such a design will be described and illustrated using two case studies. |
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