Group Sequential and Confirmatory Adaptive Designs in Clinical Trials
This book provides an up-to-date review of the general principles and techniques of confirmatory adaptive designs, a generalization of group sequential designs. With these designs, interim analyses are performed in order to stop a trial prematurely under control of the Type I error rate. In adaptive...
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Springer Nature Switzerland : Imprint: Springer,
2025.
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| Edisyon: | 2nd ed. 2025. |
| Seri Bilgileri: | Springer Series in Pharmaceutical Statistics,
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| Online Erişim: | https://doi.org/10.1007/978-3-031-89669-9 |
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| 245 | 1 | 0 | |a Group Sequential and Confirmatory Adaptive Designs in Clinical Trials |h [electronic resource] / |c by Gernot Wassmer, Werner Brannath. |
| 250 | |a 2nd ed. 2025. | ||
| 264 | 1 | |a Cham : |b Springer Nature Switzerland : |b Imprint: Springer, |c 2025. | |
| 300 | |a 1 online resource (XXIII, 410 p. 51 illus.). |b 2 illus. in color. | ||
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| 505 | 0 | |a Part I Group Sequential Designs -- Repeated Significance Tests Procedures with Equally Sized Stages -- Procedures with Unequally Sized Stages -- Confidence Intervals, p -Values, and Point Estimation -- Applications -- Part II Adaptive Confirmatory Designs with a Single Hypothesis: Adaptive Group Sequential Tests -- Decision Tools for Adaptive Designs -- Estimation and p-Values for Two-stage Adaptive Designs -- Adaptive Designs with Survival Data -- Part III Adaptive Designs with Multiple Hypotheses: Multiple Testing in Adaptive Designs -- Applications and Case Studies -- Appendix - Software for Adaptive Designs -- Index. | |
| 520 | |a This book provides an up-to-date review of the general principles and techniques of confirmatory adaptive designs, a generalization of group sequential designs. With these designs, interim analyses are performed in order to stop a trial prematurely under control of the Type I error rate. In adaptive designs, it is also permissible to perform a data-driven change of relevant aspects of the study design at interim stages. This includes, for example, a sample-size reassessment, a treatment-arm selection, or a selection of a pre-specified sub-population. First introduced in the 1990s, this popular adaptive methodology has become the focus of intense discussion and is still a rapidly growing field of statistical research. The book describes adaptive design methodology at an elementary level, while also considering design and planning issues. It also looks at methods for analyzing an adaptively planned trial, such as estimation methods and methods for determining an overall p-value. Part I provides the group sequential preliminaries required to understand and apply the adaptive design methodology supplied in Parts II and III. Many examples are included that illustrate the practical applications of the techniques. An overview of recent developments is given and, new to this edition, detailed descriptions of the R commands used for the calculations are provided. The R package rpact, which is available on CRAN, allows for the recalculation of most tables and results presented in the monograph. The required knowledge of R has been kept to a minimum, and an online Shiny app has been made available for rpact. Primarily written for applied statisticians from academia and industry who are interested in confirmatory adaptive designs, the text is also suitable for an advanced statistical course for applied statisticians or clinicians with a sound statistical background. | ||
| 532 | 8 | |a Accessibility summary: This PDF has been created in accordance with the PDF/UA-1 standard to enhance accessibility, including screen reader support, described non-text content (images, graphs), bookmarks for easy navigation, keyboard-friendly links and forms and searchable, selectable text. We recognize the importance of accessibility, and we welcome queries about accessibility for any of our products. If you have a question or an access need, please get in touch with us at accessibilitysupport@springernature.com. Please note that a more accessible version of this eBook is available as ePub. | |
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| 700 | 1 | |a Brannath, Werner. |e author. |4 aut |4 http://id.loc.gov/vocabulary/relators/aut | |
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