Clinical event adjudication in cardiovascular device trials: An Food and Drug Administration perspective

American Heart Journal

Volumn 191, Issue , 2017, Pages 62-64

  Farb, Andrew ^a   Zuckerman, Bram D ^a  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL DECISION MAKING; CLINICAL EFFECTIVENESS; CLINICAL TRIAL (TOPIC); CONSENSUS DEVELOPMENT; CRITERION VARIABLE; DEVICE APPROVAL; EDITORIAL; FOOD AND DRUG ADMINISTRATION; HUMAN; PEER REVIEW ORGANIZATION; PRIORITY JOURNAL; QUALITY CONTROL; SCIENTIFIC LITERATURE; BIOASSAY; CARDIOVASCULAR SYSTEM; MARKETING;

CARDIOVASCULAR SYSTEM; ENDPOINT DETERMINATION; MARKETING; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85019702172     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2017.05.010     Document Type: Editorial

References (5)

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5. Psaty, B.M., Delaney, J.A., PhD, et al. Study of cardiovascular health outcomes in the era of claims data: the Cardiovascular Health Study. Circulation 133 (2016), 156–164.