The role of the data and safety monitoring board in a clinical trial: The CRISIS study

Pediatric Critical Care Medicine

Volumn 14, Issue 4, 2013, Pages 374-383

  Holubkov, Richard ^a   Casper, T Charles ^a   Dean, J Michael ^a   Anand, K J S ^b   Zimmerman, Jerry ^c   Meert, Kathleen L ^d   Newth, Christopher J L ^e   Berger, John ^f   Harrison, Rick ^g   Willson, Douglas F ^h   Nicholson, Carol ⁱ  

^a UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

^c UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^d CHILDREN'S HOSPITAL OF MICHIGAN   (United States)

^e CHILDREN S HOSPITAL LOS ANGELES   (United States)

^f CHILDREN'S NATIONAL MEDICAL CENTER   (United States)

^g UNIVERSITY OF CALIFORNIA   (United States)

^h UNIVERSITY OF VIRGINIA CHILDREN S HOSPITAL   (United States)

ⁱ EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

Author keywords

Clinical trials; Interim analysis; Nosocomial infection; Randomized; Safety; Sepsis

Indexed keywords

ANTIBIOTIC AGENT;

ANTIBIOTIC THERAPY; ARTICLE; CASE STUDY; CHILDHOOD MORTALITY; CHILL; CRITICALLY ILL PATIENT; DATA ANALYSIS; DRUG APPROVAL; FEVER; FOOD AND DRUG ADMINISTRATION; HOSPITAL DISCHARGE; HOSPITAL INFECTION; HOSPITALIZED CHILD; HUMAN; HYPOTENSION; IMMUNOCOMPROMISED PATIENT; INFECTION RATE; INTENSIVE CARE; LENGTH OF STAY; LYMPHOCYTOPENIA; MONITORING; NARRATIVE; OLIGURIA; PRIORITY JOURNAL; PROFESSIONAL STANDARD; PROTOCOL COMPLIANCE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAFETY; SAMPLE SIZE; SEPSIS; STUDY DESIGN;

ADOLESCENT; BIOMEDICAL RESEARCH; CHILD; CHILD, PRESCHOOL; CLINICAL TRIALS DATA MONITORING COMMITTEES; CRITICAL ILLNESS; CROSS INFECTION; EARLY TERMINATION OF CLINICAL TRIALS; GLUTAMINE; HUMANS; IMMUNE TOLERANCE; INFANT; INTENSIVE CARE UNITS, PEDIATRIC; MEDICAL FUTILITY; METOCLOPRAMIDE; PROFESSIONAL ROLE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; SELENIUM; SEPSIS; STRESS, PHYSIOLOGICAL; TIME FACTORS; ZINC;

EID: 84877737398     PISSN: 15297535     EISSN: 19473893     Source Type: Journal    
DOI: 10.1097/PCC.0b013e318274568c     Document Type: Article

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