Both authors contributed equally to this work
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
Article first published online: 3 MAY 2012
Copyright © 2012 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Supplement: Methods for Developing and Analyzing Clinically Rich Data for Patient-Centered Outcomes Research
Volume 21, Issue Supplement S2, pages 37–43, May 2012
How to Cite
Aplenc, R., Fisher, B. T., Huang, Y. S., Li, Y., Alonzo, T. A., Gerbing, R. B., Hall, M., Bertoch, D., Keren, R., Seif, A. E., Sung, L., Adamson, P. C. and Gamis, A. (2012), 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. Pharmacoepidem. Drug Safe., 21: 37–43. doi: 10.1002/pds.3241
- Issue published online: 3 MAY 2012
- Article first published online: 3 MAY 2012
- Manuscript Accepted: 27 JAN 2012
- Manuscript Revised: 26 JAN 2012
- Manuscript Received: 17 AUG 2011
- National Institutes of Health, Bethesda, MD, USA. Grant Numbers: U10 CA98543-08, 1R01 CA133881
- administrative data;
- acute myeloid leukemia;
- cooperative oncology group;
- comparative effectiveness;
- clinical trials
The National Cancer Institute–funded cooperative oncology group trials have improved overall survival for children with cancer from 10% to 85% and have set standards of care for adults with malignancies. Despite these successes, cooperative oncology groups currently face substantial challenges. We are working to develop methods to improve the efficiency and effectiveness of these trials. Specifically, we merged data from the Children's Oncology Group (COG) and the Pediatric Health Information Systems (PHIS) to improve toxicity monitoring, to estimate treatment-associated resource utilization and costs, and to address important clinical epidemiology questions.
COG and PHIS data on patients enrolled on a phase III COG trial for de novo acute myeloid leukemia at 43 PHIS hospitals were merged using a probabilistic algorithm. Resource utilization summary statistics were then tabulated for the first chemotherapy course based on PHIS data.
Of 416 patients enrolled on the phase III COG trial at PHIS centers, 392 (94%) were successfully matched. Of these, 378 (96%) had inpatient PHIS data available beginning at the date of study enrollment. For these, daily blood product usage and anti-infective exposures were tabulated and standardized costs were described.
These data demonstrate that patients enrolled in a cooperative group oncology trial can be successfully identified in an administrative data set and that supportive care resource utilization can be described. Further work is required to optimize the merging algorithm, map resource utilization metrics to the National Cancer Institute Common Toxicity Criteria for monitoring toxicity, to perform comparative effectiveness studies, and to estimate the costs associated with protocol therapy. Copyright © 2012 John Wiley & Sons, Ltd.