A practical guide to data monitoring committees in adaptive trials

Therapeutic Innovation and Regulatory Science

Volumn 48, Issue 3, 2014, Pages 316-326

  Sanchez Kam, Matilde ^a   Gallo, Paul ^b   Loewy, John ^c   Menon, Sandeep ^d,e   Antonijevic, Zoran ^f   Christensen, Jared ^d   Chuang Stein, Christy ^d   Laage, Thomas ^g  

^a ARENA PHARMACEUTICALS   (United States)

^b NOVARTIS PHARMA AG   (Switzerland)

^c Biostatistics qPharmetra Inc   (United States)

^d PFIZER INC   (United States)

^e BOSTON UNIVERSITY   (United States)

^f Cytel Incorporated   (United States)

^g Regulatory Medical Writing and Product Development Consulting Premier Research Group   (United States)

Author keywords

Adaptive trials; Data monitoring committees; Examples; Practical guide

Indexed keywords

ADAPTATION; ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); CONFIDENTIALITY; DECISION MAKING; DOCUMENTATION; DRUG INDUSTRY; HUMAN; INTERPERSONAL COMMUNICATION; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PLANNING; POPULATION; PRIORITY JOURNAL; PROCESS DEVELOPMENT; PROFESSIONAL STANDARD; RESPONSIBILITY; SAFETY; SAMPLE SIZE; SCIENTIST; STUDY DESIGN; ADAPTIVE CLINICAL TRIAL; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLASSIFICATION; DOSE CALCULATION; DOSE RESPONSE; EXPERIMENTAL THERAPY; FOOD AND DRUG ADMINISTRATION; FORCED EXPIRATORY VOLUME; HIGH RISK PATIENT; HISTORY OF MEDICINE; MEDICAL DOCUMENTATION; MEDICAL EDUCATION; MONITORING; NOMENCLATURE; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT SAFETY; PERCUTANEOUS CORONARY INTERVENTION; PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL (TOPIC); STATISTICAL ANALYSIS;

CANGRELOR; CLOPIDOGREL; DULAGLUTIDE; FORMOTEROL; INDACATEROL; PLACEBO; TIOTROPIUM BROMIDE;

EID: 84905101394     PISSN: 21684790     EISSN: 21684804     Source Type: Journal    
DOI: 10.1177/2168479013509805     Document Type: Article

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