A note on sample size savings with the use of a single well-controlled clinical trial to support the efficacy of a new drug

Pharmaceutical Statistics

Volumn 3, Issue 1, 2004, Pages 61-63

  Darken, Patrick F ^a,b   Ho, Shu Yen ^a,b  

^a ALTANA Pharma US   (United States)

^b GLAXOSMITHKLINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

ANALYTICAL ERROR; ARTICLE; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; HUMAN; SAMPLE SIZE; SENSITIVITY ANALYSIS; SINGLE BLIND PROCEDURE; STATISTICAL ANALYSIS;

EID: 10644220394     PISSN: 15391604     EISSN: None     Source Type: Journal    
DOI: 10.1002/pst.84     Document Type: Article

References (2)

1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Satistical Principles for Clinical Trials. 1998. www.emea.eu.int
2. EMEA, CPMP Points to consider on application with 1. Meta Analysis; 2. One pivotal study. EMA: London, 2001. www.emea.eu.int