Lessons learned from the investigational device exemption review of Children's Oncology Group Trial AAML1031

Clinical Cancer Research

Volumn 18, Issue 6, 2012, Pages 1547-1554

  Meshinchi, Soheil ^a   Hunger, Stephen P ^b,c   Aplenc, Richard ^d,e   Adamson, Peter C ^d   Jessup, J Milburn ^f,g  

^a Fred Hutchinson Cancer Research Center   (United States)

^b CHILDREN S HOSPITAL COLORADO   (United States)

^c Children's Hospital Colorado   (United States)

^d CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

^e UNIVERSITY OF PENNSYLVANIA   (United States)

^f CHILDREN S ONCOLOGY GROUP   (United States)

^g NATIONAL CANCER INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CCAAT ENHANCER BINDING PROTEIN ALPHA; CD135 ANTIGEN; NUCLEOPHOSMIN;

ACUTE GRANULOCYTIC LEUKEMIA; CEPB ALPHA GENE; CLINICAL PROTOCOL; CLINICAL RESEARCH; DISEASE MARKER; FLT3 GENE; FOOD AND DRUG ADMINISTRATION; GENE; GENE MUTATION; GENETIC MARKER; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMAN; MEDICAL DECISION MAKING; MOLECULAR DIAGNOSIS; NPM1 GENE; PATENT; PRIORITY JOURNAL; RELIABILITY; REPRODUCIBILITY; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; VALIDATION PROCESS;

CLINICAL TRIALS, PHASE III AS TOPIC; DEVICE APPROVAL; GOVERNMENT REGULATION; HUMANS; LEUKEMIA, MYELOID, ACUTE; MOLECULAR DIAGNOSTIC TECHNIQUES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TUMOR MARKERS, BIOLOGICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VALIDATION STUDIES AS TOPIC;

EID: 84858210814     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-11-2205     Document Type: Review

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