Statistical approaches to group sequential monitoring of postmarket safety surveillance data: Current state of the art for use in the Mini-Sentinel pilot

Pharmacoepidemiology and Drug Safety

Volumn 21, Issue SUPPL. 1, 2012, Pages 72-81

  Cook, Andrea J ^a,b   Tiwari, Ram C ^c   Wellman, Robert D ^a   Heckbert, Susan R ^a,b   Li, Lingling ^d   Heagerty, Patrick ^b   Marsh, Tracey ^a   Nelson, Jennifer C ^a,b  

^a GROUP HEALTH RESEARCH INSTITUTE   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^d HARVARD MEDICAL SCHOOL   (United States)

Author keywords

Group sequential monitoring; Incident user cohort; Observational study; Postmarket; Signal refinement; Surveillance

Indexed keywords

ARTICLE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; ELECTRONIC MEDICAL RECORD; FOOD AND DRUG ADMINISTRATION; MAXIMUM LIKELIHOOD METHOD; OBSERVATIONAL STUDY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; SAMPLING; SEQUENTIAL ANALYSIS; STATISTICAL ANALYSIS;

COHORT STUDIES; ELECTRONIC HEALTH RECORDS; HUMANS; MODELS, STATISTICAL; OUTCOME ASSESSMENT (HEALTH CARE); PHARMACEUTICAL PREPARATIONS; PILOT PROJECTS; PRODUCT SURVEILLANCE, POSTMARKETING; PROSPECTIVE STUDIES; REGRESSION ANALYSIS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84862908275     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.2320     Document Type: Article

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