Challenges to data monitoring committees when regulatory authorities intervene

New England Journal of Medicine

Volumn 374, Issue 16, 2016, Pages 1580-1584

  Swedberg, Karl ^a,b   Borer, Jeffrey S ^d   Pitt, Bertram ^e   Pocock, Stuart ^c   Rouleau, Jean ^f  

^a UNIVERSITY OF GOTHENBURG   (Sweden)

^b NATIONAL HEART AND LUNG INSTITUTE   (United Kingdom)

^c LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^d SUNY DOWNSTATE MEDICAL CENTER   (United States)

^e UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^f MONTREAL HEART INSTITUTE   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ALISKIREN; ANGIOTENSIN RECEPTOR ANTAGONIST; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; ENALAPRIL; PLACEBO; AMIDE; FUMARIC ACID DERIVATIVE; RENIN;

ACUTE HEART FAILURE; ARTICLE; CARDIOVASCULAR MORTALITY; CHRONIC KIDNEY DISEASE; CLINICAL STUDY; CLINICAL TRIAL (TOPIC); DRUG EFFICACY; DRUG SAFETY; HEALTH CARE ORGANIZATION; HEART FAILURE; HUMAN; HYPERKALEMIA; HYPERTENSION; KIDNEY DYSFUNCTION; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PATIENT MONITORING; PATIENT SAFETY; PRIORITY JOURNAL; PROFESSIONAL STANDARD; PROFESSIONAL STANDARDS REVIEW ORGANIZATION; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGULATORY AUTHORITY; RISK BENEFIT ANALYSIS; RISK REDUCTION; TREATMENT WITHDRAWAL; UNSPECIFIED SIDE EFFECT; ANTAGONISTS AND INHIBITORS; DIABETES MELLITUS, TYPE 2; GOVERNMENT REGULATION;

AMIDES; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CLINICAL TRIALS DATA MONITORING COMMITTEES; DIABETES MELLITUS, TYPE 2; FUMARATES; GOVERNMENT REGULATION; HEART FAILURE; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RENIN;

EID: 84964411810     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMsb1601674     Document Type: Article

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