An introductory note to the CHMP guidelines: Choice of the non-inferiority margin and data monitoring committees [1]

Statistics in Medicine

Volumn 26, Issue 1, 2007, Pages 230-233

  Hauschke, Dieter ^a   Hothorn, Ludwig A ^b  

^a Altana Pharma ^*  (Germany)

^b LEIBNIZ UNIVERSITY HANNOVER   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO;

CLINICAL PRACTICE; CLINICAL RESEARCH; EUROPE; HEALTH STATISTICS; INFORMATION PROCESSING; INTERMETHOD COMPARISON; LETTER; MATHEMATICAL ANALYSIS; NULL HYPOTHESIS; PRACTICE GUIDELINE; RESEARCH ETHICS; SAMPLE SIZE; SENSITIVITY ANALYSIS;

EID: 33846250780     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.2665     Document Type: Letter

References (12)

1. Committee for Medical Products for Human Use (CHMP). Guideline on the choice of the non-inferiority margin. At http://www.emea.eu.int/pdfs/ human/ewp/215899en.pdf
2. International Conference of Harmonization (ICH). Choice of control groups in clinical trials. At http://www.emea.eu.int/pdfs/human/ich/ 036496en.pdf
3. Koch A, Röhmel J. Hypotheses testing in the gold standard design for proving the efficacy of an experimental treatment relative to placebo and a reference. Journal of Biopharmaceutical Statistics 2004; 14:315-325.
4. Hauschke D, Pigeot I. Establishing efficacy of a new experimental treatment in the gold standard design. Biometrical Journal 2005; 47:782-786, discussion 787-798.
5. Koch GG, Tangen CM. Nonparametric analysis of covariance and its role in noninferiority trials. Drug Information Journal 1999; 33:1145-1159.
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7. International Society for Clinical Biostatistics (ISCB). Comments regarding CPMP/EWP/2158/99 draft: points to consider on the choice of non-inferiority margin. At http://www.iscb.info/iscbdocs/ emea_comments-Non-inferiority.pdf
8. Pigeot I, Schäfer J, Röhmel J, Hauschke D. Assessing non-inferiority of a new treatment in a three-arm clinical trials including a placebo. Statistics in Medicine 2003; 22:883-899.
9. Hauschke D. Choice of delta: a special case. Drug Information Journal 2001; 35:875-879.
10. Dilba G, Bretz F, Hothorn LA, Guiard V. Power and sample size computations in simultaneous tests for non-inferiority based on relative margins. Statistics in Medicine 2006; 25:1131-1147.
11. Hung HMJ, Wang S-J, O'Neill R. A regulatory perspective on choice of margin and statistical issue in non-inferiority trials. Biometrical Journal 2005; 47:28-36.
12. International Biometric Society - German Region (IBS-GR). Comments on CPMP Points to consider of non-inferiority margin (CPMP/EWP/2158/99 draft). At http://www.dkfz-heidelberg.de/biostatistics/IBS/dokumente/ Comments_CPMPEWP215899_DRIBS.pdf