# Improving Adverse Event Reporting on Cooperative Oncology Group Trials

> **NIH NIH K07** · EMORY UNIVERSITY · 2020 · $169,884

## Abstract

PROJECT SUMMARY/ABSTRACT
Background: The reports of side effects on clinical trials describe expected toxicities of chemotherapy.
However, these side effects, also called adverse events, are globally under-reported on trials, which means
that clinicians do not have an accurate sense of adverse event rates. In the current system, adverse events are
identified through time-consuming, manual medical record review. This study aims to develop a system that
uses electronic medical record data to capture complex adverse events of chemotherapy for pediatric cancer
and to prove that this method is more accurate than the current adverse event reporting system. The specific
aims of this application are to 1) develop algorithms to identify 10 complex adverse events using electronic
medical record data from children treated for acute leukemia at two large children's hospitals, 2) compare the
accuracy of this new method to that of the current system, and 3) demonstrate the utility of electronic adverse
event capture in answering clinical questions by defining the incidence and risk factors of acute kidney injury.
Methods: This study will use data from 1900 children with acute leukemia treated at the Children's Hospital of
Philadelphia (CHOP) or the Texas Children's Hospital (TCH) from 2002 through 2017. Algorithms will be
developed to identify adverse events by extracting electronic medical record data at CHOP. Once finalized, the
algorithms will be tested at TCH. Using chart abstraction data as the gold standard, the accuracy of electronic
ascertainment and of trial adverse event reports will determined, and the relative accuracy of each method will
be compared. Lastly, algorithms will extract creatinine results from the electronic medical record and the
incidence of acute kidney injury will be determined for each leukemia type and by chemotherapy regimen. Risk
factors for acute kidney injury will be explored.
Career Goals and Environment: With the support of this K07 award, the applicant, Tamara P. Miller, MD,
MSCE, will learn how to use electronic medical record data for clinical research, obtain formal training in clinical
informatics and implementation science, develop expertise in clinical trial design, and improve her knowledge of
pediatric oncology and skills in scientific writing. To complete these training goals, Dr. Miller has assembled an
experienced, complementary, and nurturing mentoring team led by her primary mentor, Richard Aplenc, MD,
PhD. Her training plan includes formal coursework in informatics, tutorials, national conferences, and research
progress and writing groups. She will benefit from the outstanding depth of resources and opportunities at
CHOP and the University of Pennsylvania. Her long-term goal is to integrate the novel system of adverse event
ascertainment she creates into pediatric oncology trials and to use the accurate datasets she develops to
answer clinically important questions. With this award, Dr. Miller will be well-po...

## Key facts

- **NIH application ID:** 9994848
- **Project number:** 5K07CA211956-04
- **Recipient organization:** EMORY UNIVERSITY
- **Principal Investigator:** Tamara Porter Miller
- **Activity code:** K07 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $169,884
- **Award type:** 5
- **Project period:** 2017-09-21 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9994848

## Citation

> US National Institutes of Health, RePORTER application 9994848, Improving Adverse Event Reporting on Cooperative Oncology Group Trials (5K07CA211956-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9994848. Licensed CC0.

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