st0013_2;
artpep;
artbin;
artsurv;
artmenu;
randomized controlled trial;
time-to-event outcome;
power;
number of events;
projection;
ARTPEP;
ART;
SAMPLE-SIZE;
SURVIVAL;
D O I:
10.1177/1536867X1001000306
中图分类号:
O1 [数学];
C [社会科学总论];
学科分类号:
03 ;
0303 ;
0701 ;
070101 ;
摘要:
In 2005, Barthel, Royston, and Babiker presented a menu-driven Stata program under the generic name of ART (assessment of resources for trials) to calculate sample size and power for complex clinical trial designs with a time-to-event or binary outcome. In this article, we describe a Stata tool called ARTPEP, which is intended to project the power and events of a. trial with a time-to-event outcome into the future given patient accrual figures so far and assumptions about event rates and other defining parameters. ARTPEP has been designed to work closely with the ART program and has an associated dialog box. We illustrate the use of ARTPEP with data from a phase III trial in esophageal cancer.
机构:
Dana Farber Canc Inst, Dept Med Oncol, Div Populat Sci, Boston, MA 02115 USADana Farber Canc Inst, Dept Med Oncol, Div Populat Sci, Boston, MA 02115 USA
Schrag, Deborah
Kim, Dae Hyun
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机构:
Hebrew Senior Life, Marcus Inst Aging Res, Boston, MA USADana Farber Canc Inst, Dept Med Oncol, Div Populat Sci, Boston, MA 02115 USA
Kim, Dae Hyun
Tang, Dejun
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机构:
Sandoz Biopharmaceut, Biostatist & Clin Submission Management, Holzkirchen, GermanyDana Farber Canc Inst, Dept Med Oncol, Div Populat Sci, Boston, MA 02115 USA
Tang, Dejun
Tian, Lu
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机构:
Stanford Univ, Sch Med, Dept Biomed Data Sci, Palo Alto, CA 94304 USADana Farber Canc Inst, Dept Med Oncol, Div Populat Sci, Boston, MA 02115 USA
Tian, Lu
Rugo, Hope S.
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机构:
Univ Calif San Francisco, Helen Diller Family Comprehens Canc Ctr, San Francisco, CA 94143 USADana Farber Canc Inst, Dept Med Oncol, Div Populat Sci, Boston, MA 02115 USA
Rugo, Hope S.
Wei, Lee-Jen
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机构:
Harvard Univ, Dept Biostat, 655 Huntington Ave, Boston, MA 02115 USADana Farber Canc Inst, Dept Med Oncol, Div Populat Sci, Boston, MA 02115 USA
机构:
UCL, Inst Clin Trials & Methodol, MRC Clin Trials Unit, 90 High Holborn, London WC1V 6LJ, EnglandUCL, Inst Clin Trials & Methodol, MRC Clin Trials Unit, 90 High Holborn, London WC1V 6LJ, England
Royston, Patrick
Parmar, Mahesh K. B.
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机构:
UCL, Inst Clin Trials & Methodol, MRC Clin Trials Unit, 90 High Holborn, London WC1V 6LJ, EnglandUCL, Inst Clin Trials & Methodol, MRC Clin Trials Unit, 90 High Holborn, London WC1V 6LJ, England
机构:
PSL Res Univ, Inst Curie, INSERM, U900, F-92210 St Cloud, FrancePSL Res Univ, Inst Curie, INSERM, U900, F-92210 St Cloud, France
Meddis, Alessandra
Latouche, Aurelien
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机构:
PSL Res Univ, Inst Curie, INSERM, U900, F-92210 St Cloud, France
Conservatoire Natl Arts & Metiers, Paris, FrancePSL Res Univ, Inst Curie, INSERM, U900, F-92210 St Cloud, France
Latouche, Aurelien
Zhou, Bingqing
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机构:
Blueprint Med, Cambridge, MA USAPSL Res Univ, Inst Curie, INSERM, U900, F-92210 St Cloud, France
Zhou, Bingqing
Michiels, Stefan
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机构:
Gustave Roussy, Serv Biostat & Epidemiol, Villejuif, France
Univ Paris Sud, Univ Paris Saclay, INSERM, CESP U1018, Villejuif, FrancePSL Res Univ, Inst Curie, INSERM, U900, F-92210 St Cloud, France
Michiels, Stefan
Fine, Jason
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机构:
Univ N Carolina, Dept Biostat, Chapel Hill, NC 27515 USAPSL Res Univ, Inst Curie, INSERM, U900, F-92210 St Cloud, France