Back to basics: Explaining sample size in outcome trials, are statisticians doing a thorough job?

Pharmaceutical Statistics

Volumn 8, Issue 4, 2009, Pages 333-345

  Carroll, Kevin J ^a  

^a ASTRAZENECA   (United Kingdom)

Author keywords

Critical value; Hypothesized effect; Outcome trials; Power; Sample size

Indexed keywords

HYPOTHESIS; OUTCOME ASSESSMENT; REVIEW; SAMPLE SIZE; STATISTICAL ANALYSIS; STATISTICS;

BIOSTATISTICS; CLINICAL TRIALS AS TOPIC; DRUG DISCOVERY; HEALTH PLANNING GUIDELINES; HUMANS; MODELS, STATISTICAL; SAMPLE SIZE; TREATMENT OUTCOME;

EID: 73949126929     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.362     Document Type: Review

References (17)

1. Stern MP. On the need for outcome trials in preventive pharmacology. Diabetes Care 1999; 22(5):844-845.
2. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemotherapy Reports 1966; 50(3):163-170.
3. Peto R, Peto J. Asymptotically Efficient Rank Invariant Test procedures. Journal of the Royal Statistical Society Series A 1972; 135(2):185-207.
4. Schoenfeld D. The asymptotic properties of nonparametric tests for comparing survival distributions. Biometrika 1981; 68:316-319.
5. Rubinstein RV, Gail MH, Santner JT. Planning the duration of a comparative clinical trial with loss to follow-up and a period of continued observation. Journal of Chronic Diseases 1991; 34:469-479.
6. Carroll KJ. On the use and utility of the Weibull model in the analysis of survival data. Controlled Clinical Trials 2003; 24:682-701.
7. Sellke T, Siegmund D. Sequential analysis of the proportional hazards model. Biometrika 1983; 70:315-326.
8. Schoenfeld DA. Sample size formula for the proportional-hazards regression model. Biometrics 1983; 39:449-1983.
9. Morgan TM. Nonparametric estimation of duration of accrual and total study length for clinical trials. Biometrics 1987; 43:903-912.
10. Cantor AB. Power calculation for the Log Rank Test using historical data. Controlled Clinical Trials 1996; 17:111-116.
11. Rubinstein LV et al. Planning the duration of a comparative clinical trial with loss to follow-up and a period of continued observation. Journal of Chronic Diseases 1981; 34:469-479.
12. Gross AJ et al. Sample size determination in clinical trials with an emphasis on exponentially distributed responses. Biometrics 1987; 43:875-883.
13. Elashoff JD. nQuery advisor version 4.0. Users guide. Statistical Solutions Ltd.: Boston, 2000.
14. Bernstein D, Lagakos SW. Sample size and power determination for stratified clinical trials. The Journal of Statistical Computation and Simulation 1978; 8: 65-73.
15. Yateman NA, Skene AM. Sample sizes for proportional hazards survival studies with arbitrary patient entry and loss to follow-up distributions. Statistics in Medicine 1992; 11:1103-1113.
16. Williford WO et al. The 'Constant Intake Rate' assumption in interim recruitment goal methodology for multicenter clinical trials. Journal of Chronic Diseases 1987; 40:297-307.
17. Hunninghake DB, Darby CA, Probstfield JL. Recruitment experience in clinical trials: literature summary and annotated bibliography. Controlled Clinical Trials 1987; 8:6S-30S.