Adding dose modifications into Phase II and Phase II/III seamless trials
We present a technique for adding dose modifications into seamless Phase II and Phase II/III trials featuring dose selection at an interim analysis. The method is convenient to apply and can be used either in a fully prespecified, structured way or as a response to new considerations that emerge at interim. Strong control of the familywise error rate regarding false declarations of efficacy versus control is maintained. Two examples are given. One illustrates how the method could potentially "save" a trial performed in a Phase II context. The other is a seamless Phase II/III trial that uses an adaptive exploration strategy for an assumed nonmonotonic dose-response curve. It can result in greatly improved efficiency over a standard "promote the winner" rule.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:29 |
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| Enthalten in: |
Statistical methods in medical research - 29(2020), 5 vom: 03. Mai, Seite 1315-1324 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Spivack, John [VerfasserIn] |
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| Links: |
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| Themen: |
Adaptive design |
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| Anmerkungen: |
Date Completed 01.03.2023 Date Revised 01.03.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1177/0962280219859387 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 520 | |a We present a technique for adding dose modifications into seamless Phase II and Phase II/III trials featuring dose selection at an interim analysis. The method is convenient to apply and can be used either in a fully prespecified, structured way or as a response to new considerations that emerge at interim. Strong control of the familywise error rate regarding false declarations of efficacy versus control is maintained. Two examples are given. One illustrates how the method could potentially "save" a trial performed in a Phase II context. The other is a seamless Phase II/III trial that uses an adaptive exploration strategy for an assumed nonmonotonic dose-response curve. It can result in greatly improved efficiency over a standard "promote the winner" rule | ||
| 650 | 4 | |a Journal Article | |
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| 700 | 1 | |a Levin, Bruce |e verfasserin |4 aut | |
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