Merging of the National Cancer Institute-funded cooperative oncology group data with an administrative data source to develop a more effective platform for clinical trial analysis and comparative effectiveness research: A report from the Children's Oncology Group

Pharmacoepidemiology and Drug Safety

Volumn 21, Issue SUPPL.2, 2012, Pages 37-43

  Aplenc, R ^a,b   Fisher, B T ^a,b   Huang, Y S ^a   Li, Y ^a   Alonzo, T A ^c   Gerbing, R B ^c   Hall, M ^d   Bertoch, D ^d   Keren, R ^a   Seif, A E ^a   Sung, L ^e   Adamson, P C ^a   Gamis, A ^f  

^a CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^d Child Health Corporation of America   (United States)

^e HOSPITAL FOR SICK CHILDREN   (Canada)

^f CHILDREN S MERCY HOSPITAL   (United States)

Author keywords

Acute myeloid leukemia; Administrative data; Clinical trials; Comparative effectiveness; Cooperative oncology group

Indexed keywords

ANTIBIOTIC AGENT; ANTIFUNGAL AGENT; ANTIVIRUS AGENT; GEMTUZUMAB;

ACUTE GRANULOCYTIC LEUKEMIA; ADOLESCENT; ADULT; ANTIBIOTIC THERAPY; ANTIVIRAL THERAPY; ARTICLE; CANCER CHEMOTHERAPY; CHILD; CHILDHOOD LEUKEMIA; COMPARATIVE STUDY; CONTROLLED STUDY; DRUG MONITORING; DRUG SAFETY; FEMALE; HEALTH CARE COST; HEALTH CARE UTILIZATION; HUMAN; MAJOR CLINICAL STUDY; MALE; NATIONAL HEALTH ORGANIZATION; PHARMACOEPIDEMIOLOGY; PHASE 3 CLINICAL TRIAL; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; STATISTICS; UNSPECIFIED SIDE EFFECT;

ADOLESCENT; CHILD; CHILD HEALTH SERVICES; CHILD, PRESCHOOL; CLINICAL TRIALS, PHASE III AS TOPIC; COOPERATIVE BEHAVIOR; COSTS AND COST ANALYSIS; FEMALE; HOSPITALS, PEDIATRIC; HUMANS; INFANT; MALE; MEDICAL ONCOLOGY; MEDICAL RECORD LINKAGE; MEDICAL RECORDS SYSTEMS, COMPUTERIZED; NATIONAL CANCER INSTITUTE (U.S.); NEOPLASMS; ORGANIZATIONAL OBJECTIVES; OUTCOME AND PROCESS ASSESSMENT (HEALTH CARE); UNITED STATES; YOUNG ADULT;

EID: 84860549778     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3241     Document Type: Article

References (17)

1. Nass SJ, Moses HL, Mendelsohn J. A National Cancer Clinical Trials System for the 21st Century; Reinvigorating the NCI Cooperative Group Program. Washington, DC: Institute of Medicine, 2010; 317.
2. Adamson P. 2011.
3. Lamont EB, Herndon JE, 2nd, Weeks JC, et al. Measuring clinically significant chemotherapy-related toxicities using Medicare claims from Cancer and Leukemia Group B (CALGB) trial participants. Med Care 2008; 46(3): 303-308.
4. Lamont EB, Herndon JE, 2nd, Weeks JC, et al. Measuring disease-free survival and cancer relapse using Medicare claims from CALGB breast cancer trial participants (companion to 9344). J Natl Cancer Inst 2006; 98(18): 1335-1338.
5. Lamont EB, Herndon JE, 2nd, Weeks JC, et al. Criterion validity of Medicare chemotherapy claims in Cancer and Leukemia Group B breast and lung cancer trial participants. J Natl Cancer Inst 2005, 97(14): 1080-1083.
6. Fisher BT, Aplenc R, Localio R, et al. Cefepime and mortality in pediatric acute myelogenous leukemia: a retrospective cohort study. Pediatr Infect Dis J 2009; 28(11): 971-975.
7. Fisher BT, Zaoutis TE, Leckerman KH, et al. Risk factors for renal failure in pediatric patients with acute myeloid leukemia: a retrospective cohort study. Pediatr Blood Cancer 2010; 55(4): 655-661.
8. Cooper TM, Franklin J, Gerbing RB, et al. AAML03P1, a pilot study of the safety of gemtuzumab ozogamicin in combination with chemotherapy for newly diagnosed childhood acute myeloid leukemia: A report from the children's oncology group. Cancer 2012; 118(3): 761-769.
9. Ries L, Smith M, Gurney J, et al. (eds). Cancer Incidence and Survival among Children and Adolescents: United States SEER Program 1975-1995. National Cancer Institute: Bethesda, MD, 1999; 182.
10. Sung L, Aplenc R, Zaoutis T, et al. Infections in pediatric acute myeloid leukemia: lessons learned and unresolved questions. Pediatr Blood Cancer 2008; 51(4): 458-460.
11. Rosenman MB, Vik T, Hui SL, et al. Hospital resource utilization in childhood cancer. J Pediatr Hematol Oncol 2005; 27(6): 295-300.
12. Mahoney MR, Sargent DJ, O'Connell MJ, et al. Dealing with a deluge of data: an assessment of adverse event data on North Central Cancer Treatment Group trials. J Clin Oncol 2005; 23(36): 9275-9281.
13. Scharf O, Colevas AD. Adverse event reporting in publications compared with sponsor database for cancer clinical trials. J Clin Oncol 2006; 24(24): 3933-3938.
14. Kaiser LD, Melemed AS, Preston AJ, et al. Optimizing collection of adverse event data in cancer clinical trials supporting supplemental indications. J Clin Oncol 28(34): 5046-5053.
15. Zaoutis T, Localio AR, Leckerman K, et al. Prolonged intravenous therapy versus early transition to oral antimicrobial therapy for acute osteomyelitis in children. Pediatrics 2009; 123(2): 636-642.
16. Newman K, Ponsky T, Kittle K, et al. Appendicitis 2000: variability in practice, outcomes, and resource utilization at thirty pediatric hospitals. J Pediatr Surg 2003; 38(3): 372-379; discussion 372-9.
17. Benchimol EI, Manuel DG, To T, et al. Development and use of reporting guidelines for assessing the quality of validation studies of health administrative data. J Clin Epidemiol 64(8): 821-829.