National Cancer Institute (NCI) funded cooperative oncology group trials have improved overall survival for children with cancer from 10% to 85% over the past five decades, and have set standards of care for adults with malignancies. However, according to the Institute of Medicine: "the clinical trial system is approaching a state of crisis". If [it] does not improve its efficiency and effectiveness, the introduction of new treatments for cancer will be delayed and patient lives will be lost unnecessarily. This application proposes to improve toxicity monitoring, estimate treatment associated resource utilization and costs, and serve as a platform for answering important clinical epidemiology questions by merging data from the Children's Oncology Group (COG) and the Pediatric Health Information Systems (PHIS) administrative data base for patients treated for de novo acute myeloid leukemia (AML) on recent Phase III clinical trials. Four hypotheses underpin this application: (1) We hypothesize that greater than 95% of patients enrolled on recent and current COG AML trials can be identified in PHIS;(2) COG-PHIS merged data will more accurately report adverse events than unmerged data;(3) COG-PHIS merged data can prospectively monitor a Phase III trial for adverse events;(4) COG-PHIS merged data will describe standardized costs of treatment by regimen arm and enable analyses of cost variation. This application has significance both as a methodological advancement and in the use of this methodology to improve toxicity monitoring and outcome analysis in cooperative group oncology trials. Furthermore, this application is highly innovative as the first merging of cooperative grou clinical trial data with administrative data. Finally, the approach taken in this application shoul be applicable not only to other pediatric malignancies, but also to adult cancers generally. Thus, the application is likely to have a high impact on the care of both children and adults with cancer.

Public Health Relevance

This application proposes to improve toxicity monitoring, estimate treatment associated resource utilization and costs, and serve as a platform for answering important clinical epidemiology questions by merging data from the Children's Oncology Group (COG) and the Pediatric Health Information Systems (PHIS) administrative data base for patients treated for de novo acute myeloid leukemia (AML) on recent Phase III clinical trials. This application has significance both as a methodological advancement and in the use of this methodology to improve toxicity monitoring and outcome analysis in cooperative group oncology trials. Furthermore, the approach taken in this application should be applicable not only to other pediatric malignancies, but also to adult cancers generally, and thus have broad public health impact.

Agency
National Institute of Health (NIH)
Type
Research Project (R01)
Project #
5R01CA165277-03
Application #
8676741
Study Section
Epidemiology of Cancer Study Section (EPIC)
Program Officer
Witherspoon, Kim
Project Start
Project End
Budget Start
Budget End
Support Year
3
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Children's Hospital of Philadelphia
Department
Type
DUNS #
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
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Fisher, Brian T; Kavcic, Marko; Li, Yimei et al. (2014) Antifungal prophylaxis associated with decreased induction mortality rates and resources utilized in children with new-onset acute myeloid leukemia. Clin Infect Dis 58:502-8
Desai, Ami V; Kavcic, Marko; Huang, Yuan-Shung et al. (2014) Establishing a high-risk neuroblastoma cohort using the Pediatric Health Information System Database. Pediatr Blood Cancer 61:1129-31
Fisher, Brian T; Singh, Sonia; Huang, Yuan-Shung et al. (2014) Induction mortality, ATRA administration, and resource utilization in a nationally representative cohort of children with acute promyelocytic leukemia in the United States from 1999 to 2009. Pediatr Blood Cancer 61:68-73
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Kavcic, Marko; Fisher, Brian T; Torp, Kari et al. (2013) Assembly of a cohort of children treated for acute myeloid leukemia at free-standing children's hospitals in the United States using an administrative database. Pediatr Blood Cancer 60:508-11