Literature DB >> 8720017

Sample size calculation for complex clinical trials with survival endpoints.

J H Shih1.   

Abstract

Sample size estimation is important in planning clinical trials. The purpose of this paper is to describe features and use of SIZE, a comprehensive computer program for calculating sample size, power, and duration of study in clinical trials with time-dependent rates of event, crossover, and loss to follow-up. SIZE covers a wide range of complexities commonly occurring in clinical trials, such as nonproportional hazards, lag in treatment effect, and uncertainties in treatment benefit. The use of SIZE is illustrated by several hypothetical examples as well as applications to real study designs, each featuring a statistical issue.

Mesh：

Year:  1995        PMID： 8720017     DOI： 10.1016/s0197-2456(95)00132-8

Source DB:  PubMed          Journal:  Control Clin Trials        ISSN： 0197-2456


  15 in total

1.  The Long-Term Oxygen Treatment Trial for Chronic Obstructive Pulmonary Disease: Rationale, Design, and Lessons Learned.

Authors:  Roger D Yusen; Gerard J Criner; Alice L Sternberg; David H Au; Anne L Fuhlbrigge; Richard K Albert; Richard Casaburi; James K Stoller; Kathleen F Harrington; J Allen D Cooper; Philip Diaz; Steven Gay; Richard Kanner; Neil MacIntyre; Fernando J Martinez; Steven Piantadosi; Frank Sciurba; David Shade; Thomas Stibolt; James Tonascia; Robert Wise; William C Bailey
Journal:  Ann Am Thorac Soc       Date:  2018-01

2.  Cognitive function over time in the Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT): results of a randomized, controlled trial of naproxen and celecoxib.

Authors:  Barbara K Martin; Christine Szekely; Jason Brandt; Steven Piantadosi; John C S Breitner; Suzanne Craft; Denis Evans; Robert Green; Michael Mullan
Journal:  Arch Neurol       Date:  2008-05-12

3.  The design and conduct of clinical trials to limit missing data.

Authors:  R J Little; M L Cohen; K Dickersin; S S Emerson; J T Farrar; J D Neaton; W Shih; J P Siegel; H Stern
Journal:  Stat Med       Date:  2012-07-25       Impact factor: 2.373

4.  Angiotensin-converting-enzyme inhibition in stable coronary artery disease.

Authors:  Eugene Braunwald; Michael J Domanski; Sarah E Fowler; Nancy L Geller; Bernard J Gersh; Judith Hsia; Marc A Pfeffer; Madeline M Rice; Yves D Rosenberg; Jean L Rouleau
Journal:  N Engl J Med       Date:  2004-11-07       Impact factor: 91.245

5.  Designing therapeutic cancer vaccine trials with delayed treatment effect.

Authors:  Zhenzhen Xu; Boguang Zhen; Yongsoek Park; Bin Zhu
Journal:  Stat Med       Date:  2016-11-02       Impact factor: 2.373

6.  Power and sample size calculation for log-rank test with a time lag in treatment effect.

Authors:  Daowen Zhang; Hui Quan
Journal:  Stat Med       Date:  2009-02-28       Impact factor: 2.373

7.  Designing cancer immunotherapy trials with random treatment time-lag effect.

Authors:  Zhenzhen Xu; Yongsoek Park; Boguang Zhen; Bin Zhu
Journal:  Stat Med       Date:  2018-09-10       Impact factor: 2.373

8.  Cardiovascular and cerebrovascular events in the randomized, controlled Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT).

Authors: 
Journal:  PLoS Clin Trials       Date:  2006-11-17

9.  An internet-based adolescent depression preventive intervention: study protocol for a randomized control trial.

Authors:  Tracy G Gladstone; Monika Marko-Holguin; Phyllis Rothberg; Jennifer Nidetz; Anne Diehl; Daniela T DeFrino; Mary Harris; Eumene Ching; Milton Eder; Jason Canel; Carl Bell; William R Beardslee; C Hendricks Brown; Kathleen Griffiths; Benjamin W Van Voorhees
Journal:  Trials       Date:  2015-05-01       Impact factor: 2.279

10.  A data similarity-based strategy for meta-analysis of transcriptional profiles in cancer.

Authors:  Qingchao Qiu; Pengcheng Lu; Yuzhu Xiang; Yu Shyr; Xi Chen; Brian David Lehmann; Daniel Joseph Viox; Alfred L George; Yajun Yi
Journal:  PLoS One       Date:  2013-01-29       Impact factor: 3.240
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