An R package for implementing simulations for seamless phase II/III clinical trials using early outcomes for treatment selection
2012 | journal article. A publication with affiliation to the University of Göttingen.
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An R package for implementing simulations for seamless phase II/III clinical trials using early outcomes for treatment selection
Parsons, N.; Friede, T.; Todd, S.; Marquez, E. V.; Chataway, J.; Nicholas, R. & Stallard, N. (2012)
Computational Statistics & Data Analysis, 56(5) pp. 1150-1160. DOI: https://doi.org/10.1016/j.csda.2010.10.027
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Details
- Authors
- Parsons, Nick; Friede, Tim; Todd, Susan; Marquez, Elsa Valdes; Chataway, Jeremy; Nicholas, Richard; Stallard, Nigel
- 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. (C) 2010 Elsevier B.V. All rights reserved.
- Issue Date
- 2012
- Status
- published
- Publisher
- Elsevier Science Bv
- Journal
- Computational Statistics & Data Analysis
- ISSN
- 1872-7352; 0167-9473