Is the large simple trial design used for comparative, post-approval safety research?: A review of a clinical trials registry and the published literature

Drug Safety

Volumn 34, Issue 10, 2011, Pages 799-820

  Reynolds, Robert F ^a,b   Lem, Joanna A ^a   Gatto, Nicolle M ^a,b   Eng, Sybil M ^c  

^a PFIZER INC   (United States)

^b TULANE UNIVERSITY   (United States)

^c Global Health Insights   (United States)

Author keywords

Clinical trial design; Pharmacoepidemiology; Pharmacovigilance; Postmarketing surveillance; Randomised controlled trials

Indexed keywords

CLINICAL EVALUATION; CLINICAL TRIAL (TOPIC); COMPARATIVE STUDY; DRUG RESEARCH; DRUG SAFETY; MEDICAL PRACTICE; PRIORITY JOURNAL; RESEARCH PRIORITY; REVIEW; RISK ASSESSMENT; STUDY DESIGN;

BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG TOXICITY; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; PUBLISHING; REGISTRIES; RESEARCH DESIGN; SAMPLE SIZE;

EID: 80052340990     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.2165/11593820-000000000-00000     Document Type: Review

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