Assessing the impact of ICH E9

Pharmaceutical Statistics

Volumn 7, Issue 2, 2008, Pages 77-87

  Brown, David ^a   Day, Simon ^b   Hemmings, Rob ^a   Wright, David ^a  

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

^b ROCHE PRODUCTS LTD   (United Kingdom)

Author keywords

Confirmatory clinical trials; Marketing authorization application; Regulatory guidance

Indexed keywords

ANALYTICAL ERROR; ARTICLE; CLINICAL PRACTICE; CONFIDENCE INTERVAL; EUROPEAN UNION; HUMAN; JAPAN; MEDICAL LITERATURE; METHODOLOGY; PRACTICE GUIDELINE; SAMPLE SIZE; STATISTICAL MODEL; STATISTICAL SIGNIFICANCE; UNITED STATES; CLINICAL TRIAL; MULTICENTER STUDY; STATISTICS;

CLINICAL TRIALS AS TOPIC; GUIDELINES AS TOPIC; HUMANS; MULTICENTER STUDIES AS TOPIC; RESEARCH DESIGN; SAMPLE SIZE; STATISTICS AS TOPIC;

EID: 46449131540     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.337     Document Type: Article

References (10)

1. ICH Topic E9 Statistical Principles for Clinical Trials (CPMP/ICH/363/ 96), www.emea.europa.eu, 1998. Accessed 5th February 2008.
2. Points to Consider on Adjustment for Baseline Covariates (CPMP/EWP/2863/ 99), www.emea.europa.eu, 2003. Accessed 5th February 2008.
3. ICH Topic E10 Choice of Control Group in Clinical Trials (CPMP/ICH/364/ 96), www.emea.europa.eu, 2001. Accessed 5th February 2008.
4. Points to Consider on Switching between Superiority and Non-inferiority (CPMP/EWP/482/99), www.emea.europa.eu, 2001. Accessed 5th February 2008.
5. Note for guidance on Choice of a Non-Inferiority Margin (CPMP/EWP/2158/ 99), www.emea.europa.eu, 2006. Accessed 5th February 2008.
6. ICH Topic El Population Exposure: The Extent of Population Exposure to Assess Clinical Safety (CPMP/ICH/375/95), 1995. Accessed 5th February 2008.
7. Note for guidance on Evaluation of Anticancer Medicinal Products in Man (CPMP/EWP/205/95 Rev. 3), www.emea.europa.eu, 2006. Accessed 5th February 2008.
8. Points to Consider on Missing Data (CPMP/EWP/1776/99), www.emea.europa.eu, 2002. Accessed 5th February 2008.
9. Recommendation for revision of the points to consider on missing data (CHMP/EWP/439980/07), www.emea.europa.eu, 2007. Accessed 5th February 2008.
10. Points to Consider on Application with 1. Meta-analyses; 2. One pivotal study (CPMP/EWP/2330/99), www.emea.europa.eu, 2001. Accessed 5th February 2008.