Tests for equivalence or non-inferiority - Why?

Drug and Therapeutics Bulletin

Volumn 46, Issue 7, 2008, Pages 55-56

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Author keywords

[No Author keywords available]

Indexed keywords

DRUG; PLACEBO;

BIOEQUIVALENCE; DATA ANALYSIS; DRUG RESEARCH; SHORT SURVEY; ARTICLE; CLINICAL TRIAL; HUMAN; PHARMACOKINETICS;

CLINICAL TRIALS AS TOPIC; HUMANS; PHARMACEUTICAL PREPARATIONS; THERAPEUTIC EQUIVALENCY;

EID: 55449123976     PISSN: 00126543     EISSN: None     Source Type: Journal    
DOI: 10.1136/dtb.2008.06.0016     Document Type: Short Survey

References (8)

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2. Pocock SJ. The pros and cons of noninferiority trials. Fundam Clin Pharmacol 2003; 17: 483-90.
3. European Medicines Agency, 1998. Notes for guidance on statistical principles for clinical trials [online]. Available: http://www.emea.europa. eu/pdfs/human/ich/036396en.pdf [Accessed 13 June 2008].
4. Piaggio G et al. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 2006; 295: 1152-60.
5. European Medicines Agency, 2000. Points to consider on switching between superiority and non-inferiority [online]. Available: http://www.emea.europa.eu/pdfs/human/ewp/048299en.pdf [Accessed 13 June 2008].
6. Garattini S, Bertele' V. Non-inferiority trials are unethical because they disregard patients' interests. Lancet 2007; 370: 1875-7.
7. European Medicines Agency, 2005. Guideline on the choice of the non-inferiority margin [online]. Available: http://www.emea.europa.eu/pdfs/ human/ewp/215899en.pdf [Accessed 13 June 2008].
8. Le Henanff A et al. Quality of reporting of noninferiority and equivalence randomised trials. JAMA 2006; 295: 1147-51.