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Group-sequential methods for adaptive seamless phase II/III clinical trials
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Stallard, Nigel (2011) Group-sequential methods for adaptive seamless phase II/III clinical trials. Journal of Biopharmaceutical Statistics, Vol.21 (No.4). pp. 787-801. doi:10.1080/10543406.2011.551335
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Official URL: http://dx.doi.org/10.1080/10543406.2011.551335
Abstract
The last 10 years have seen considerable interest in clinical trial designs that allow the seamless combination of Phases II and III in a single clinical trial. Such designs bring together the selection of the most promising of a number of treatments, as usually performed in a Phase II clinical trial, with the rigorous analysis and control of type I error rates required for a Phase III clinical trial. Statistically, the challenge is that of allowing for multiple comparisons arising both from repeated analyses of the accumulating data and from selection of a treatment on the basis of data that will be included in the final analysis. This challenge can be met in a number of different ways. This paper reviews methods based on the group-sequential methodology for monitoring of sequential clinical trials. The main focus of the paper will be a description of the methodology, including the setting in which short-term data are used for decision making at an early interim analysis.
| Item Type: | Journal Article | ||||
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| Subjects: | Q Science > QA Mathematics R Medicine > R Medicine (General) |
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| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Clinical trials -- Design, Clinical trials -- Statistical methods, Therapeutics -- Testing | ||||
| Journal or Publication Title: | Journal of Biopharmaceutical Statistics | ||||
| Publisher: | Taylor & Francis Inc. | ||||
| ISSN: | 1054-3406 | ||||
| Official Date: | 2011 | ||||
| Dates: |
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| Volume: | Vol.21 | ||||
| Number: | No.4 | ||||
| Page Range: | pp. 787-801 | ||||
| DOI: | 10.1080/10543406.2011.551335 | ||||
| Status: | Peer Reviewed | ||||
| Publication Status: | Published | ||||
| Access rights to Published version: | Restricted or Subscription Access | ||||
| Description: | Special Issue: Dealing with multiplicity in drug development: current state and new directions |
Data sourced from Thomson Reuters' Web of Knowledge
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