Choice of control in clinical trials - Issues and implications of ICH-E10

Drug Information Journal

Volumn 35, Issue 4, 2001, Pages 1147-1156

  Huitfeldt, Bernhard ^a   Danielson, Linda ^a   Ebbutt, Alan ^a   Schmidt, Karsten ^a  

^a ASTRAZENECA R AND D   (Sweden)

Author keywords

Clinical trial environment; Control group; Declaration of Helsinki; ICH E10; Noninferiority trials; Placebo controlled trials

Indexed keywords

PLACEBO;

ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG INDUSTRY; DRUG RESEARCH; DRUG SAFETY; HUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; TREATMENT OUTCOME;

EID: 0035739453     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150103500411     Document Type: Article

References (6)

1. International Conference on Harmonization
2. Points to consider
3. Placebo-controlled trials and active-controlled trials in the evaluation of new treatments, Part 1: Ethical and scientific issues
4. Placebo-controlled trials and active-controlled trials in the evaluation of new treatments, Part 2: Practical issues and specific cases issues
5. Helsinki Discord? A Controversial Declaration