Phase IV non-inferiority trials and additional claims of benefit

BMC Medical Research Methodology

Volumn 13, Issue 1, 2013, Pages

  Bernabe, Rosemarie D L C ^a   Wangge, Grace ^b   Knol, Mirjam J ^c   Klungel, Olaf H ^b   Van Delden, Johannes Jm ^a   De Boer, Anthonius ^b   Hoes, Arno W ^a   Raaijmakers, Jan Am ^b,d   Van Thiel, Ghislaine Jmw ^a  

^a UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^b UTRECHT UNIVERSITY   (Netherlands)

^c NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

^d GLAXOSMITHKLINE   (Netherlands)

Author keywords

Additional benefit; Clinical relevance; Ethics; Non inferiority; Post authorization

Indexed keywords

DRUG;

ARTICLE; FEMALE; HUMAN; MALE; PHASE 4 CLINICAL TRIAL; PHASE 4 CLINICAL TRIAL (TOPIC); RISK ASSESSMENT; SAFETY; STANDARD;

CLINICAL TRIALS, PHASE IV AS TOPIC; FEMALE; HUMANS; MALE; PHARMACEUTICAL PREPARATIONS; RISK ASSESSMENT; SAFETY;

EID: 84878220257     PISSN: None     EISSN: 14712288     Source Type: Journal    
DOI: 10.1186/1471-2288-13-70     Document Type: Article

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