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Dtsch Med Wochenschr 2007; 132: e53-e56
DOI: 10.1055/s-2007-959043
DOI: 10.1055/s-2007-959043
Statistik | Statistics
© Georg Thieme Verlag Stuttgart · New York
Äquivalenzstudien und Nicht-Unterlegenheitsstudien
- Artikel Nr. 20 der Statistik-Serie in der DMW -Equivalence and non-inferiority trialsFurther Information
Publication History
Publication Date:
25 May 2007 (online)
Schlüsselwörter
Äquivalenz - Nicht-Unterlegenheit - Klinisch relevante Differenz - Konfidenzintervall
Key words
Equivalence - Non-inferiority - Clinically relevant difference - Confidence interval
Literatur
- 1 Altman D G, Bland J M. Absence of evidence is not evidence of absence. BMJ. 1995; 311 485
- 2 Bender R, Lange S. Was ist der p-Wert?. Dtsch Med Wochenschr. 2007; 132 e15-e16
- 3 Blackwelder W C. „Proving the null hypothesis” in clinical trials. Control Clin Trials. 1982; 3 345-353
- 4 CPMP . Biostatistical methodology in clinical trials in applications for marketing authorizations for medicinal products. CPMP Working Party on Efficacy of Medicinal Products Note for Guidance III/3630/92-EN. Stat Med. 1995; 14 1659-1682
- 5 CPMP .Guideline on the choice of the non-inferiority margin. CPMP/EWP/2158/99 2005. http://www.emea.eu.int/pdfs/human/ewp/215899en.pdf (letzter Zugriff am 25.9.2005) 2005
- 6 CPMP .Points to consider on switching between superiority and non-inferiority. CPMP/EWP/482/99 2000. http://www.emea.eu.int/pdfs/human/ewp/048299en.pdf (letzter Zugriff am 25.9.2005) 2005
- 7 Garbe E, Röhmel J, Gundert-Remy U. Clinical and statistical issues in therapeutic equivalence trials. Eur J Clin Pharmacol. 1993; 45 1-7
- 8 Hampton J R. Mega-trials and equivalence trials: experience from the INJECT study. Eur Heart J. 1996; 17 (Suppl E) 28-34
- 9 Hampton J R. Alternatives to mega-trials in cardiovascular disease. Cardiovasc Drugs Ther. 1997; 10 759-765
- 10 Hartung J, Cottrell J E, Giffen J P. Absence of evidence is not evidence of absence. Anesthesiology. 1983; 58 298-300
- 11 Henry D, Hill S. Comparing treatments: Comparison should be against active treatments rather than placebos. BMJ. 1995; 310 1279
- 12 ICH Harmonised Tripartite Guideline . Statistical principles for clinical trials (E9). Stat Med. 1999; 18 1905-1942
- 13 ICH Harmonised Tripartite Guideline .Choice of control group and related issues in clinical trials (E10). http://www.emea.eu.int/pdfs/human/ich/036496en.pdf (letzter Zugriff am 25.9.2005) 2000
- 14 International Joint Efficacy Comparison of Thrombolytics . Randomised, double-blind comparison of reteplase double-bolus administration with streptokinase in acute myocardial infarction (INJECT): trial to investigate equivalence. Lancet. 1995; 346 329-335
- 15 Jones B, Jarvis P, Lewis J A, Ebbutt A F. Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996; 313 36-39
- 16 Lange S, Bender R. Was ist ein Signifikanztest?. Dtsch Med Wochenschr. 2007; 132 e19-e21
- 17 Lange S, Windeler J. Das Konzept der therapeutischen Äquivalenz. Med Klin. 1997; 92 215-220
- 18 Makuch R, Johnson M. Issues in planning and interpreting active control equivalence studies. J Clin Epidemiol. 1989; 42 503-511
- 19 Makuch R, Pledger G, Hall D B, Johnson M F, Herson J, Hsu J -P. Active Control Equivalence Studies. In: Peace KE; Hrsg. Statistical issues in drug research and development New York: Marcel Dekker, 1990: 225-262
- 20 Modell W, Houde R W. Factors influencing clinical evaluation of drugs. With special reference to the double-blind technique. JAMA. 1958; 167 2190-2199
- 21 Senn S J. Inherent difficulties with active control equivalence studies. Stat Med. 1993; 12 2367-2375
- 22 Wellek S. Planung und statistische Auswertung von Äquivalenzstudien im Rahmen der klassischen Theorie des Hypothesentestens. In: Michaelis J, Hommel G, Wellek S; Hrsg. Europäische Perspektiven der Medizinischen Informatik, Biometrie und Epidemiologie München: MMV, Medizin-Verlag 1993: 143-147
- 23 Wellek S. Testing Statistical Hypotheses of Equivalence. Boca Raton: Chapman & Hall/CRC 2003
- 24 Windeler J, Trampisch H J. Empfehlung zur Durchführung von Studien zur therapeutischen Äquivalenz. Inform Biom Epidem Med Biol. 1995; 26 350-355
- 25 World Medical Association .Declaration of Helsinki - Ethical principles for medical research involving human subjects. Revision of the 52nd WMA General Assembly, Edinburgh, Scotland http://www.wma.net/e/policy/b3.htm (letzter Zugriff am 25.9.2005) 2000
Privatdozent Dr. rer. biol. hum. Ralf Bender
Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG)
Dillenburger Straße 27
51105 Köln
Email: ralf.bender@iqwig.de