Authors' reply [2]

Statistics in Medicine

Volumn 26, Issue 1, 2007, Pages 234-236

  Brown, David ^a   Day, Simon ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO;

ACCURACY; CLINICAL PRACTICE; CLINICAL RESEARCH; CONSENSUS DEVELOPMENT; LETTER; MATHEMATICAL ANALYSIS; PRACTICE GUIDELINE; RISK BENEFIT ANALYSIS; SAMPLE SIZE;

EID: 33846191506     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.2664     Document Type: Letter

References (4)

1. Committee for Medicinal Products for Human Use (CHMP). Guideline on the choice of the non-inferiority margin. Available fro www.emea.eu.int/pdfs/ human/ewp/215899en.pdf.
2. Brow D, Volkers P, Day S. An introductory note to the CHMP guidelines: choice of the non-inferiority margin and data monitoring committees. Statistics in Medicine 2006; 25:1623-1627.
3. Rothmann M, Li N, Chen G, Chi GYH, Temple R, Tsou H-H. Design and analysis of non-inferiority mortality trials in oncology. Statistics in Medicine 2003; 22:239-264.
4. Koch A, Röhmel J. Hypothesis 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.