Trials to assess equivalence: The importance of rigorous methods

British Medical Journal

Volumn 313, Issue 7048, 1996, Pages 36-39

  Jones, B ^a,b   Jarvis, P ^a   Lewis, J A ^a,b,d   Ebbutt, A F ^c  

^a DE MONTFORT UNIVERSITY   (United Kingdom)

^b Department of Medical Statistics ^*  (United Kingdom)

^c GLAXOSMITHKLINE   (United Kingdom)

^d MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL; DATA ANALYSIS; DRUG DESIGN; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG SCREENING; METHODOLOGY; PRIORITY JOURNAL; STATISTICS;

EID: 0029987569     PISSN: 09598146     EISSN: None     Source Type: Journal    
DOI: 10.1136/bmj.313.7048.36     Document Type: Article

References (14)

1. Rothman KJ, Michels KB. The continuing unethical use of placebo controls. N Engl J Med 1994;331:394-8.
2. Taubes G. Use of placebo controls in clinical trials disputed. Science 1995;267:25-6.
3. The use of placebo controls. N Engl J Med 1995;332:60-2.
4. Henry D, Hill S. Comparing treatments: comparison should be against active treatments rather than placebo. BMJ 1995;310:1279.
5. Makuch RW, Pledger G, Hall DB, Johnson MF, Herson J, Hsu J-P. Active control equivalence studies. In: Peace K, ed. Statistical issues in drug research and development. New York: Marcel Dekker, 1990:225-62.
6. Temple R. Government viewpoint of clinical trials. Drug Information Journal 1982;16:10-7.
7. Altman DG, Bland JM. Absence of evidence is not evidence of absence. BMJ 1995;311:485.
8. Lewis JA, Jones DR, Röhmel J. Biostatistical methodology in clinical trials - a European guideline. Statistics in Medicine 1995;14:1655-7.
9. CPMP Working Party on Efficacy of Medicinal Products. Biostatistical methodology in clinical trials in applications for marketing authorizations for medicinal products. Note for guidance III/3630 92-EN. Statistics in Medicine 1995;14: 1658-82.
10. Lewis JA, Machin D. Intention to treat - who should use ITT. Br J Cancer 1992;68:647-50.
11. Salsburg D, Intent to treat: the reductio ad absurdum that became gospel-Pharmacoepidemiology and Drug Safety 1994;3:329-35.
12. Campbell MJ, Julious SA, Altman DG. Estimating sample sizes for binary, ordered categorical and continuous outcomes in two group comparisons. BMJ 1995;311:1145-8.
13. Pocock SJ. Clinical trials: a practical approach. Chichester: Wiley, 1983.
14. Makuch R, Simon R. Sample size requirements for evaluating a conservative therapy. Cancer Treatment Reports 1978;62:1037-40.