Sample size recalculation in three-stage clinical trials and its evaluation
In clinical trials, the determination of an adequate sample size is a challenging task, mainly due to the uncertainty about the value of the effect size and nuisance parameters. One method to deal with this uncertainty is a sample size recalculation. Thereby, an interim analysis is performed based o...
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| Main Authors: | , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
[25 September 2024]
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| In: |
BMC medical research methodology
Year: 2024, Volume: 24, Issue: 1, Pages: 214-1-214-15 |
| ISSN: | 1471-2288 |
| DOI: | 10.1186/s12874-024-02337-9 |
| Online Access: | Verlag, kostenfrei, Volltext: https://doi.org/10.1186/s12874-024-02337-9
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| Author Notes: | Björn Bokelmann, Geraldine Rauch, Jan Meis, Meinhard Kieser, Carolin Herrmann |
| Summary: | In clinical trials, the determination of an adequate sample size is a challenging task, mainly due to the uncertainty about the value of the effect size and nuisance parameters. One method to deal with this uncertainty is a sample size recalculation. Thereby, an interim analysis is performed based on which the sample size for the remaining trial is adapted. With few exceptions, previous literature has only examined the potential of recalculation in two-stage trials. |
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| Item Description: | Gesehen am 04.06.2025 |
| Physical Description: | Online Resource |
| ISSN: | 1471-2288 |
| DOI: | 10.1186/s12874-024-02337-9 |