Relationship between sample size and the definition of equivalence in non-inferiority drug studies

Journal of Clinical Pharmacy and Therapeutics

Volumn 27, Issue 5, 2002, Pages 329-333

  Millar, J A ^a,b   Burke, V ^b  

^a UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^b ROYAL PERTH HOSPITAL   (Australia)

Author keywords

Clinical trials; Non inferiority; Statistical testing; Therapeutic equivalence

Indexed keywords

ANALYTICAL ERROR; DRUG RESEARCH; HYPOTHESIS; METHODOLOGY; PROBABILITY; REVIEW; SAMPLE SIZE; STATISTICAL ANALYSIS; STATISTICAL DISTRIBUTION; STATISTICAL PARAMETERS; TREATMENT OUTCOME; ARTICLE; CLINICAL TRIAL; HUMAN; PHARMACOKINETICS; STATISTICS;

NEW DRUG;

CLINICAL TRIALS; DRUGS, INVESTIGATIONAL; HUMANS; SAMPLE SIZE; THERAPEUTIC EQUIVALENCY;

EID: 0036405072     PISSN: 02694727     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1365-2710.2002.00412.x     Document Type: Review

References (11)

1. Armitage P, Berry G. (1994) Statistical Methods in Medical Research. Oxford: Blackwell Scientific Publications, 201-202.
2. Blackwelder WC. (1982) 'Proving H0' in clinical trials. Controlled Clinical Trials, 3, 345-353.
3. Dunnett CW, Gent M. (1977) Significance testing to establish equivalence between treatments, with special reference to data in the form of 2 × 2 tables. Biometrics, 33, 593-602.
4. Makuch R, Simon R. (1978) Sample size requirements for evaluating a conservative therapy. Cancer Treatment Reports, 62, 1037-1040.
5. Metzler CM. (1974) Bioavailability - A problem in equivalence. Biometrics, 30, 309-317.
6. Spriet A, Beiler D. (1979) When can 'nonsignificantly different' treatments be considered as 'equivalent'? British Journal of Clinical Pharmacology, 7, 623-624.
7. Westlake WJ. (1976) Symmetrical confidence intervals for bioequivalence trials. Biometrics, 32, 741-744.
8. Bristol DR. (1999) Clinical equivalence. Journal of Biopharmaceutical Statistics, 9, 549-561.
9. Massel D. (1999) Similar, the same or just not different: A guide for deciding whether treatments are clinically equivalent. Canadian Journal of Cardiology, 15, 556-562.
10. Anonymous. International Conference on Harmonisation Guidelines E9, E10. Statistical Principles for Clinical Trials. http://www.ifpma.org.
11. Miall WE, Greenberg G. (1987) Mild Hypertension: Is there Pressure to Treat? Cambridge: Cambridge University Press.