10 years of ICH E9

Pharmaceutical Statistics

Volumn 7, Issue 1, 2008, Pages 1-3

  Lewis, John ^a,b  

^a NEWCASTLE UNIVERSITY   (United Kingdom)

^b NONE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ADVISORY COMMITTEE; BIOSTATISTICS; CONSENSUS DEVELOPMENT; DRUG INDUSTRY; EDITORIAL; EUROPE; PRACTICE GUIDELINE; PROFESSIONAL DEVELOPMENT; PUBLICATION; STATISTICAL ANALYSIS; STATISTICS; UNITED STATES;

ANNIVERSARIES AND SPECIAL EVENTS; CLINICAL TRIALS AS TOPIC; DATA INTERPRETATION, STATISTICAL; EUROPE; GUIDELINE ADHERENCE; GUIDELINES AS TOPIC; HUMANS; INTERNATIONAL COOPERATION; JAPAN; RESEARCH DESIGN; TIME FACTORS; UNITED STATES;

EID: 40749136296     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.320     Document Type: Editorial

References (8)

1. International Conference on Harmonisation (ICH). Statistical principles for clinical trials, ICH topic E9. EMEA: Canary Wharf, London, 1998.
2. CPMP Working Party on Efficacy of Medicinal Products. Biostatistical methodology in clinical trials in applications for marketing authorisations for medicinal products. Statistics in Medicine 1995; 14:1658-1682.
3. Lewis JA, Jones DR, Röhmel J. Biostatistical methodology in clinical trials - a European guideline. Statistics in Medicine 1995; 14: 1655-1657.
4. Lewis JA. Statistical principles for clinical trials: an introductory note on an international guideline. Statistics in Medicine 1999; 18:1903-1904.
5. International Conference on Harmonisation (ICH). Choice of control group in clinical trials, ICH topic E10. EMEA: Canary Wharf, London, 2000.
6. Snapinn SM. Alternatives for discounting in the analysis of noninferiority trials. Journal of Biopharmaceutical Statistics 2004; 14: 263-273.
7. Committee for Medicinal Products for Human Use (CHMP). Guideline on the choice of the non-inferiority margin. EMEA: Canary Wharf, London, 2005.
8. Lewis J, Louv W, Rockhold F, Sato T. The impact of the guideline entitled Statistical Principles for Clinical Trials (ICH E9). Statistics in Medicine 2001; 20: 2549-2560.