Centralized adjudication of cardiovascular end points in cardiovascular and noncardiovascular pharmacologic trials: A report from the Cardiac Safety Research Consortium

American Heart Journal

Volumn 169, Issue 2, 2015, Pages 197-204

  Seltzer, Jonathan H ^a   Turner, J Rick ^b   Geiger, Mary Jane ^c   Rosano, Giuseppe ^d   Mahaffey, Kenneth W ^e   White, William B ^f   Sabol, Mary Beth ^g   Stockbridge, Norman ^h   Sager, Philip T ^e  

^a ACI Clinical   (United States)

^b IQVIA   (United States)

^c REGENERON PHARMACEUTICALS INC   (United States)

^d EUROPEAN MEDICINES AGENCY   (United Kingdom)

^e STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f UNIVERSITY OF CONNECTICUT SCHOOL OF MEDICINE   (United States)

^g GLAXOSMITHKLINE   (United States)

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

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; ARTIFICIAL INTELLIGENCE; CARDIOVASCULAR DISEASE; CLINICAL DECISION MAKING; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); CONSENSUS; COST EFFECTIVENESS ANALYSIS; DRUG INDUSTRY; DYSPNEA; ELECTRONIC MEDICAL RECORD; EUROPEAN MEDICINES AGENCY; FATIGUE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HEART FAILURE; HUMAN; MEDICAL DICTIONARY FOR REGULATORY ACTIVITIES; MEDICAL SPECIALIST; PATIENT SAFETY; PRIORITY JOURNAL; PROTOCOL COMPLIANCE; QUALITY CONTROL; RISK ASSESSMENT; THORAX PAIN; BIOASSAY; CARDIOLOGY; CARDIOVASCULAR DISEASES; METHODOLOGY; PHARMACOLOGY; PROCEDURES; PROFESSIONAL STANDARD; SAFETY; STANDARDS; UNITED STATES;

BENCHMARKING; CARDIOLOGY; CARDIOVASCULAR DISEASES; CLINICAL TRIALS AS TOPIC; CLINICAL TRIALS DATA MONITORING COMMITTEES; ENDPOINT DETERMINATION; HUMANS; PHARMACOLOGICAL PHENOMENA; RESEARCH DESIGN; SAFETY MANAGEMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84921831937     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2014.11.003     Document Type: Review

References (12)

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