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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
Reference Ris Wihthout Link
- 2
Bender R, Lange S.
Was ist der p-Wert?.
Dtsch Med Wochenschr.
2007;
132
e15-e16
Reference Ris Wihthout Link
- 3
Blackwelder W C.
„Proving the null hypothesis” in clinical trials.
Control Clin Trials.
1982;
3
345-353
Reference Ris Wihthout Link
- 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
Reference Ris Wihthout Link
- 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
Reference Ris Wihthout Link
- 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
Reference Ris Wihthout Link
- 7
Garbe E, Röhmel J, Gundert-Remy U.
Clinical and statistical issues in therapeutic equivalence trials.
Eur J Clin Pharmacol.
1993;
45
1-7
Reference Ris Wihthout Link
- 8
Hampton J R.
Mega-trials and equivalence trials: experience from the INJECT study.
Eur Heart J.
1996;
17
(Suppl E)
28-34
Reference Ris Wihthout Link
- 9
Hampton J R.
Alternatives to mega-trials in cardiovascular disease.
Cardiovasc Drugs Ther.
1997;
10
759-765
Reference Ris Wihthout Link
- 10
Hartung J, Cottrell J E, Giffen J P.
Absence of evidence is not evidence of absence.
Anesthesiology.
1983;
58
298-300
Reference Ris Wihthout Link
- 11
Henry D, Hill S.
Comparing treatments: Comparison should be against active treatments rather than placebos.
BMJ.
1995;
310
1279
Reference Ris Wihthout Link
- 12
ICH Harmonised Tripartite Guideline .
Statistical principles for clinical trials (E9).
Stat Med.
1999;
18
1905-1942
Reference Ris Wihthout Link
- 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
Reference Ris Wihthout Link
- 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
Reference Ris Wihthout Link
- 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
Reference Ris Wihthout Link
- 16
Lange S, Bender R.
Was ist ein Signifikanztest?.
Dtsch Med Wochenschr.
2007;
132
e19-e21
Reference Ris Wihthout Link
- 17
Lange S, Windeler J.
Das Konzept der therapeutischen Äquivalenz.
Med Klin.
1997;
92
215-220
Reference Ris Wihthout Link
- 18
Makuch R, Johnson M.
Issues in planning and interpreting active control equivalence studies.
J Clin Epidemiol.
1989;
42
503-511
Reference Ris Wihthout Link
- 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
Reference Ris Wihthout Link
- 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
Reference Ris Wihthout Link
- 21
Senn S J.
Inherent difficulties with active control equivalence studies.
Stat Med.
1993;
12
2367-2375
Reference Ris Wihthout Link
- 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
Reference Ris Wihthout Link
- 23 Wellek S. Testing Statistical Hypotheses of Equivalence. Boca Raton: Chapman & Hall/CRC 2003
Reference Ris Wihthout Link
- 24
Windeler J, Trampisch H J.
Empfehlung zur Durchführung von Studien zur therapeutischen Äquivalenz.
Inform Biom Epidem Med Biol.
1995;
26
350-355
Reference Ris Wihthout Link
- 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
Reference Ris Wihthout Link
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