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An R package for implementing simulations for seamless phase II/III clinical trials using early outcomes for treatment selection
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Parsons, Nicholas R., Friede, Tim, Todd, S., Marquez, Elsa Valdes, Chataway, J., Nicholas, Richard and Stallard, Nigel (2012) An R package for implementing simulations for seamless phase II/III clinical trials using early outcomes for treatment selection. Computational Statistics & Data Analysis, Vol.56 (No.5). pp. 1150-1160. doi:10.1016/j.csda.2010.10.027 ISSN 0167-9473.
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Official URL: http://dx.doi.org/10.1016/j.csda.2010.10.027
Abstract
Adaptive seamless phase II/III clinical trial designs allowing treatment selection at an interim analysis have gained much attention because of their potential benefits compared to more conventional drug development programmes with separate trials for individual phases. A scenario of particular interest is that in which the final outcome in the trial is based on long-term follow-up, but the interim analysis can only realistically be based on early (short-term) outcomes. A new software package (asd) for the statistical software R implements simulations for designs of this type, in addition to the simpler scenario where treatment selection is based on the definitive (final) outcome. The methodology is briefly described and two examples of proposed trial designs in progressive multiple sclerosis are provided, with R code to illustrate application of the methodology.
| Item Type: | Journal Article | ||||
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| Subjects: | R Medicine > R Medicine (General) R Medicine > RM Therapeutics. Pharmacology |
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Clinical trials -- Methodology, Clinical trials -- Design, Clinical trials -- Mathematical models, Clinical trials -- Computer simulation, Drug development, Drugs -- Effectiveness -- Research | ||||
| Journal or Publication Title: | Computational Statistics & Data Analysis | ||||
| Publisher: | Elsevier BV | ||||
| ISSN: | 0167-9473 | ||||
| Official Date: | 1 May 2012 | ||||
| Dates: |
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| Volume: | Vol.56 | ||||
| Number: | No.5 | ||||
| Page Range: | pp. 1150-1160 | ||||
| DOI: | 10.1016/j.csda.2010.10.027 | ||||
| Status: | Peer Reviewed | ||||
| Publication Status: | Published | ||||
| Access rights to Published version: | Restricted or Subscription Access |
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