Power and sample size considerations in clinical trials with competing risk endpoints

Pharmaceutical Statistics

Volumn 5, Issue 3, 2006, Pages 159-171

  Maki, Ellen ^a  

^a Analytica Statistical Consulting Inc   (Canada)

Author keywords

Cause specific hazard; Clinical trial; Competing risks; Sample size; Weibull

Indexed keywords

ARTICLE; CLINICAL TRIAL; HUMAN; MATHEMATICAL COMPUTING; METHODOLOGY; OUTCOME ASSESSMENT; PARAMETRIC TEST; PLANNING; POWER ANALYSIS; PROBABILITY; RISK ASSESSMENT; SAMPLE SIZE; SAMPLING; STATISTICAL ANALYSIS; STATISTICAL MODEL; TIME;

CLINICAL TRIALS; DATA INTERPRETATION, STATISTICAL; ENDPOINT DETERMINATION; HUMANS; RESEARCH DESIGN; RISK; SAMPLE SIZE;

EID: 33748749537     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.200     Document Type: Article

References (12)

1. Yan Y, Moore RD, Hoover DR. Competing risk adjustment reduces overestimation of opportunistic infection rates in AIDS. Journal of Clinical Epidemiology 2000; 53:817-822.
2. Gray RJ. A class of K-sample tests for comparing the cumulative incidence of a competing risk. Annals of Statistics 1988; 16:1141-1154.
3. Pepe MS, Mori M. Kaplan-Meier, marginal or conditional probability curves in summarizing competing risks failure data? Statistics in Medicine 1993; 12:737-751.
4. Lunn M. Applying k-sample tests to conditional probabilities for competing risks in a clinical trial. Biometrics 1998; 54:1662-1672.
5. Kulathinal SB, Gasbarra D. Testing equality of cause-specific hazard rates corresponding to m competing risks among K groups. Lifetime Data Analysis 2002; 8:147-161. DOI: 10.1023/ A:1014887507027.
6. Lunn M, McNeil D. Applying Cox regression to competing risks. Biometrics 1995; 51:524-532.
7. Fine JP, Gray RJ. A proportional hazards model for the subdistribution of a competing risk. Journal of the American Statistical Association 1999; 94: 496-509.
8. Pintilie M. Dealing with competing risks: testing covariates and calculating sample size. Statistics in Medicine 2002; 21:3317-3324. DOI: 10.1002/ sim.1271.
9. Heo M, Faith MS, Allison DB. Power and sample size for survival analysis under the Weibull distribution when the whole lifespan is of interest. Mechanisms of Ageing and Development 1998; 102: 45-53.
10. Lachin JM, Foulkes MA. Evaluation of sample size and power for analyses of survival with allowance for nonuniform patient entry, losses to follow-up, noncompliance, and stratification. Biometrics 1986; 42:507-519.
11. Crowder M. Classical Competing Risks. Chapman & Hall/CRC: Boca Raton, 2001.
12. Liljegren G, Holmberg L, Bergh J, Lindgren A, Tabar L, Nordgren H, Adami HO. 10-year results after sector resection with or without postoperative radiotherapy for Stage I breast cancer: a randomized trial. Journal of Clinical Oncology 1999; 17: 2326-2333.