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An introduction to sample size calculations in clinical trials

Published online by Cambridge University Press:  18 May 2011

Simone Accordini
Simone Accordini*
Affiliation:
Unit of Epidemiology and Medical Statistics, Department of Medicine and Public Health, University of Verona, Verona, Italy
*
Address for correspondence: Dr. S. Accordini, Sezione di Epidemiologia & Statistica Medica, Dipartimento di Medicina e Sanità Pubblica, Università degli Studi di Verona, Istituti Biologici II, Strada Le Grazie 8, 37134 Verona (Italy). Fax: +39-045-505.357 E-mail: simone.accordini@univr.it
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Abstract

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Keywords

clinical trialssample sizepower analysisCHAT study
Type
ABC of Methodology
Information
Epidemiology and Psychiatric Sciences , Volume 16 , Issue 4 , December 2007 , pp. 299 - 301
Copyright
Copyright © Cambridge University Press 2007

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References

REFERENCES

Altman, D.G. (1980). Statistics and ethics in medical research. Ill How large a sample? British Medical Journal 281, 1336–1338.CrossRefGoogle Scholar
Barbui, C., Cipriani, A., Malvini, L., Nose, M., Accordini, S., Pontarollo, R, Veronese, A. & Tansella, M. (2006). Trasformare la pratica clinica in ricerca. Un invito a partecipare allo studio CHAT. Rivista di Psichiatria 41, 326–330.Google Scholar
Barbui, C., Veronese, A. & Cipriani, A. (2007). Explanatory and pragmatic trials. Epidemiologia e Psichiatria Sociale 16, 124–125.CrossRefGoogle ScholarPubMed
Cipriani, A., Nosè, M. & Barbui, C. (2007). What is a risk ratio? Epidemiologia e Psichiatria Sociale 16, 20–21.CrossRefGoogle ScholarPubMed
Chow, S.C., Shao, J. & Wang, H. (2003). Sample Size Calculations in Clinical Research. Marcel Dekker: New York.Google Scholar
Christensen, E. (2007). Methodology of superiority vs. equivalence trials and non-inferiority trials. Journal of Hepatology 46, 947–954.CrossRefGoogle ScholarPubMed
Hintze, J. (2004). NCSS and PASS. Kaysville: Number Cruncher Statistical Systems.Google Scholar
Hwang, I.K. & Morikawa, T. (1999). Design issues in noninferiority / equivalence trials. Drug Information Journal 33, 1205–1218.CrossRefGoogle Scholar
ICH. E3 (1996). Structure and content of clinical study reports. July 1996. Retrieved July 26, 2007 from http://www.fda.gov/cder/guidanceAche3.pdf.Google Scholar
ICH. E9 (1998). Statistical principles for clinical trials. September 1998. Retrieved July 26, 2007 from http://www.fda.gov/cder/guidance/ICH_E9-fnl.pdfGoogle Scholar
ICH. E10 (2001). Choice of control group and related issues in clinical trials. May 2001. Retrieved July 26, 2007 from http://www.fda.gov/cder/guidance/4155fnl.pdfGoogle Scholar
Julious, S.A. (2004). Sample sizes for clinical trials with normal data. Statistics in Medicine 23, 1921–1986.CrossRefGoogle ScholarPubMed
Lieberman, J.A., Stroup, T.S., McEvoy, J.P., Swartz, M.S., Rosenheck, R.A., Perkins, D.O., Keefe, R.S., Davis, S.M., Davis, C.E., Lebowitz, B.D., Severe, J., Hsiao, J.K. & Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators (2005). Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. New England Journal of Medicine 353, 1209–1223.CrossRefGoogle ScholarPubMed
Snapinn, S.M. (2000). Noninferiority trials. Current Controlled Trials in Cardiovascular Medicine 1, 19–21.CrossRefGoogle ScholarPubMed