Phase II clinical trials with time-to-event endpoints: optimal two-stage designs with one-sample log-rank test
Phase II clinical trials are often conducted to determine whether a new treatment is sufficiently promising to warrant a major controlled clinical evaluation against a standard therapy. We consider single‐arm phase II clinical trials with right censored survival time responses where the ordinary one...
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| Veröffentlicht in: | Statistics in medicine 2014-05, Vol.33 (12), p.2004-2016 |
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| container_end_page | 2016 |
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| container_title | Statistics in medicine |
| container_volume | 33 |
| creator | Kwak, Minjung Jung, Sin-Ho |
| description | Phase II clinical trials are often conducted to determine whether a new treatment is sufficiently promising to warrant a major controlled clinical evaluation against a standard therapy. We consider single‐arm phase II clinical trials with right censored survival time responses where the ordinary one‐sample logrank test is commonly used for testing the treatment efficacy. For planning such clinical trials, this paper presents two‐stage designs that are optimal in the sense that the expected sample size is minimized if the new regimen has low efficacy subject to constraints of the type I and type II errors. Two‐stage designs, which minimize the maximal sample size, are also determined. Optimal and minimax designs for a range of design parameters are tabulated along with examples. Copyright © 2013 John Wiley & Sons, Ltd. |
| doi_str_mv | 10.1002/sim.6073 |
| format | Article |
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Med</addtitle><description>Phase II clinical trials are often conducted to determine whether a new treatment is sufficiently promising to warrant a major controlled clinical evaluation against a standard therapy. We consider single‐arm phase II clinical trials with right censored survival time responses where the ordinary one‐sample logrank test is commonly used for testing the treatment efficacy. For planning such clinical trials, this paper presents two‐stage designs that are optimal in the sense that the expected sample size is minimized if the new regimen has low efficacy subject to constraints of the type I and type II errors. Two‐stage designs, which minimize the maximal sample size, are also determined. Optimal and minimax designs for a range of design parameters are tabulated along with examples. 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Med</addtitle><date>2014-05-30</date><risdate>2014</risdate><volume>33</volume><issue>12</issue><spage>2004</spage><epage>2016</epage><pages>2004-2016</pages><issn>0277-6715</issn><eissn>1097-0258</eissn><coden>SMEDDA</coden><abstract>Phase II clinical trials are often conducted to determine whether a new treatment is sufficiently promising to warrant a major controlled clinical evaluation against a standard therapy. We consider single‐arm phase II clinical trials with right censored survival time responses where the ordinary one‐sample logrank test is commonly used for testing the treatment efficacy. For planning such clinical trials, this paper presents two‐stage designs that are optimal in the sense that the expected sample size is minimized if the new regimen has low efficacy subject to constraints of the type I and type II errors. Two‐stage designs, which minimize the maximal sample size, are also determined. 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| ispartof | Statistics in medicine, 2014-05, Vol.33 (12), p.2004-2016 |
| issn | 0277-6715 1097-0258 |
| language | eng |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Algorithms Clinical trials Clinical Trials, Phase II as Topic - statistics & numerical data Data Interpretation, Statistical Design optimization Disease-Free Survival Drug therapy Humans logrank test minimax design optimal design Research Design Sample Size single arm trial Survival analysis Test methods time to event Treatment Outcome two-stage design |
| title | Phase II clinical trials with time-to-event endpoints: optimal two-stage designs with one-sample log-rank test |
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