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Die Beurteilung der Gleichwertigkeit von Behandlungen

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Methodik klinischer Studien

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7.8 Literatur

  • Blackwelder WC. „Proving the null hypothesis“ in clinical trials. Controlled Clinical Trials 1982; 3: 345–353.

    Article  Google Scholar 

  • Brown D, Volkers P, Day S. An introductory note to CHMP guidelines: choice of the noninferiority margin and data monitoring committees. Statistics in Medicine 2006; 25: 1623–1627.

    Article  MathSciNet  Google Scholar 

  • D’Agostino RB, Campbell M, Greenhouse J. Editorial. Non-inferiority trials: Continued advancements in concepts and methodology. Statistics in Medicine 2006; 25: 1097–1099.

    Google Scholar 

  • EMEA/CPMP. Points to Consider on switching between superiority and non-inferiority. London, UK: Committee for Proprietary Medicinal Products. Approved by the CPMP July 2000. CPMP/EWP/482/99.

    Google Scholar 

  • EMEA/CHMP. Guideline on the choice of the non-inferiority margin. London, UK: Committee for Medicinal Products for Human Use. Adoption by the CHMP July 2005. CPMP/EWP/2158/99. (Statistics in Medicine 2006; 25: 1628–1638).

    Google Scholar 

  • Farrington CP, Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Statistics in Medicine 1990; 9: 1447–1454.

    Google Scholar 

  • Harrer G, Hübner WD, Podzuweit H. Wirksamkeit und Verträglichkeit des Hypericum-Präparates LI160 im Vergleich mit Maprotilin. Nervenheilkunde 1993; 12: 297–301.

    Google Scholar 

  • Hiller KO, Rahlfs V. Therapeutische Äquivalenz eines hochdosierten Phytopharmakons mit Amitriptylin bei ängstlich-depressiven Verstimmungen-Reanalyse einer randomisierten Studie unter besonderer Beachtung biometrischer und klinischer Aspekte. Forschende Komplementärmedizin 1995; 2: 123–132.

    Article  Google Scholar 

  • ICH E9. Statistical principles for clinical trials. London, UK: International Conference on Harmonisation; 1998. Adopted by CPMP March 1998 (CPMP/ICH/363/96).

    Google Scholar 

  • Kim MY, Goldberg JD. The effects of outcome misclassification and measurement error on the design and analysis of therapeutic equivalence trials. Statistics in Medicine 2001; 20: 2065–2078.

    Article  Google Scholar 

  • Le Henanff A, Giraudeau B, Baron G, Ravaud P. Quality of reporting of noninferiority and equivalence randomized trials. Journal of the American Medical Association 2006; 295: 1147–1151.

    Article  Google Scholar 

  • Munk A, Trampisch HJ. Therapeutic equivalence — Clinical issues and statistical methodology in noninferiority trials. Biometrical Journal 2005; 47: 7–9.

    Article  Google Scholar 

  • Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJW for the CONSORT Group. Reporting of noninferiority and equivalence randomized trials. An extension of the CONSORT Statement. Journal of the American Medical Association 2006; 295: 1152–1160.

    Article  Google Scholar 

  • Roebruck R, Elze M, Hauschke D, Leverkus F, Kieser M. Literaturübersicht zur Fallzahlplanung für Äquivalenzprobleme. Informatik, Biometrie und Epidemiologie in Medizin und Biologie 1997; 2: 51–63.

    Google Scholar 

  • Röhmel J. Therapeutic equivalence investigations: statistical considerations. Statistics in Medicine 1998; 17: 1703–1714.

    Article  Google Scholar 

  • Schumacher M, Bastert G, Bojar H, Hübner K, Olschewski M, Sauerbrei W, Schmoor C, Beyerle C, Neumann RL, Rauschecker HF for the German Breast Cancer Study Group. Randomized 2×2 trial evaluating hormonal treatment and the duration of chemotherapy in node-positive breast cancer patients. Journal of Clinical Oncology 1994; 12: 2086–2093.

    Google Scholar 

  • Sauerbrei W, Bastert G, Bojar H, Beyerle C, Neumann RL, Schmoor C, Schumacher M for the German Breast Cancer Study Group. Randomized 2×2 trial evaluating hormonal treatment and the duration of chemotherapy in node-positive breast cancer patients: an update based on 10 years’ follow-up. Journal of Clinical Oncology 2000; 18: 94–101.

    Google Scholar 

  • Wellek, S. Statistische Methoden zum Nachweis von Äquivalenz. Stuttgart: Gustav Fisher, 1994.

    MATH  Google Scholar 

  • Westlake WJ. Use of confidence intervals in analysis of comparative bioavailability trials. Journal of Pharmaceutical Sciences 1972; 61: 1340–1341.

    Article  Google Scholar 

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Schwarzer, G., Schumacher, M. (2007). Die Beurteilung der Gleichwertigkeit von Behandlungen. In: Methodik klinischer Studien. Statistik und ihre Anwendungen. Springer, Berlin, Heidelberg . https://doi.org/10.1007/978-3-540-36990-5_7

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