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Subgroup Analysis using Multiple Linear Regression: Confounding, Interaction, Synergism

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Statistics Applied to Clinical Trials

Abstract

When the size of the study permits, important demographic or baseline value-defined subgroups of patients can be studied for unusually large or small efficacy responses; e.g. comparison of effects by age, sex; by severity or prognostic groups. Naturally, such analyses are not intended to “salvage” an otherwise negative study, but may be may be helpful in refining patient or dose selection for subsequent studies.1

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11. References

  1. Department of Health and Human Services, Food and Drug Administration. International Conference on Harmonisation; Guidance on Statistical Principles for Clinical Trials Availability. Federal Register, 63(179), 1998: 49583–49598.

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  2. Hosmer DW, Lemeshow S. Applied Logistic Regression. New York: Wiley, 1989.

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  3. Jukema AJ, Zwinderman AH, et al for the REGRESS study group. Effects of lipid lowering by pravastatin on progression and regression of coronary artery disease in symptomatic men with normal to moderately elevated serum cholesterol levels. The Regression Growth Evaluation Statin Study (REGRESS). Circulation. 1995 May 15; 91(10): 2528–2540

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  4. Rao CR. Linear Statistical Inference and Its Applications. New York: Wiley, 1973.

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  5. Box Cox, Statistical Software, University Leiden, Netherlands, 1999.

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© 2002 Springer Science+Business Media Dordrecht

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Cleophas, T.J., Zwinderman, A.H., Cleophas, T.F. (2002). Subgroup Analysis using Multiple Linear Regression: Confounding, Interaction, Synergism. In: Statistics Applied to Clinical Trials. Springer, Dordrecht. https://doi.org/10.1007/978-94-010-0337-7_9

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  • DOI: https://doi.org/10.1007/978-94-010-0337-7_9

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-1-4020-0570-1

  • Online ISBN: 978-94-010-0337-7

  • eBook Packages: Springer Book Archive

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