Is informed consent necessary for randomized Phase IV 'observational' drug studies?

Drug Discovery Today

Volumn 16, Issue 17-18, 2011, Pages 751-754

  Bernabe, Rosemarie D C ^a   Van Thiel, Ghislaine J M W ^a   Raaijmakers, Jan A M ^b   Van Delden, Johannes J M ^a  

^a UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^b GLAXOSMITHKLINE   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

CELECOXIB; DICLOFENAC;

BIOEQUIVALENCE; DRUG POTENCY; HUMAN; INFORMED CONSENT; MEDICAL ETHICS; OBSERVATIONAL STUDY; PHASE 4 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RHEUMATOID ARTHRITIS; RISK; WELFARE;

EID: 80052835056     PISSN: 13596446     EISSN: 18785832     Source Type: Journal    
DOI: 10.1016/j.drudis.2011.06.007     Document Type: Short Survey

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