Limb-Leaf designs for adaptive exploration of the dose-response curve
Copyright © 2017 Elsevier Inc. All rights reserved..
We propose a two-stage strategy, called the Limb-Leaf method, to explore the dose-response curve using dose promotion and addition in the context of adaptive seamless Phase II/III trials. Strong control of the overall type 1 familywise error rate of the proposed method is enforced by the closed testing principle. The design constants are determined to minimize the risk-adjusted expected total sample size while maintaining a target power. In the case of a nonmonotonic dose response curve where more doses are required to adequately explore the curve, substantial savings in sample size are achieved compared with a traditional strategy which offers only selection and promotion from among initial first stage doses.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2018 |
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| Erschienen: |
2018 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:64 |
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| Enthalten in: |
Contemporary clinical trials - 64(2018) vom: 14. Jan., Seite 210-218 |
| 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 26.02.2019 Date Revised 26.02.2019 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.cct.2017.10.002 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM276582624 |
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| 520 | |a Copyright © 2017 Elsevier Inc. All rights reserved. | ||
| 520 | |a We propose a two-stage strategy, called the Limb-Leaf method, to explore the dose-response curve using dose promotion and addition in the context of adaptive seamless Phase II/III trials. Strong control of the overall type 1 familywise error rate of the proposed method is enforced by the closed testing principle. The design constants are determined to minimize the risk-adjusted expected total sample size while maintaining a target power. In the case of a nonmonotonic dose response curve where more doses are required to adequately explore the curve, substantial savings in sample size are achieved compared with a traditional strategy which offers only selection and promotion from among initial first stage doses | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a Closed testing principle | |
| 650 | 4 | |a Dose addition | |
| 650 | 4 | |a Dose-response curve | |
| 650 | 4 | |a Nonmonotonicity | |
| 700 | 1 | |a Cheng, Bin |e verfasserin |4 aut | |
| 700 | 1 | |a Levin, Bruce |e verfasserin |4 aut | |
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