# Improving Adverse Event Reporting on Cooperative Oncology Group Trials

> **NIH NIH K07** · EMORY UNIVERSITY · 2022 · $69,390

## 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 prove that an automated
system of adverse event identification using electronic medical record (EMR) data is more accurate than the
current adverse event reporting system. The specific aims of this application are to 1) compare the accuracy of
this new method to clinical trial adverse event data captured using the current system, and 2) 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 uses data from 1900 children with acute leukemia treated at the Children’s Hospital of
Philadelphia (CHOP) or Children’s Healthcare of Atlanta (CHOA) from 2010 through 2019. Algorithms have
been developed to identify adverse events by extracting EMR data at CHOP and CHOA. Using chart
abstraction data as the gold standard, the accuracy of EMR-based ascertainment and of trial adverse event
reports will determined, and the relative accuracy of each method will be compared. Creatinine data that have
been extracted from the EMR, processed and graded will be combined with nephrotoxic medication data,
demographic data, and treatment data to determine the incidence of acute kidney injury 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 supplemental award, the applicant, Tamara P.
Miller, MD, MSCE, will determine the relative accuracy of use of EMR data compared to traditional manual
reporting for identification of adverse events. From this work the applicant will learn use how to use EMR data for
clinical research, gain knowledge about implementation science and 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, Timothy
Lash, DSc, MPH. She has completed formal coursework in informatics and her training plan includes tutorials,
national conferences, and research progress and writing groups. She will benefit from the outstanding depth of
resources and opportunities at CHOA and Emory University. 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-
positioned to transition to her goal of an independent clinical res...

## Key facts

- **NIH application ID:** 10642998
- **Project number:** 3K07CA211956-05S1
- **Recipient organization:** EMORY UNIVERSITY
- **Principal Investigator:** Tamara Porter Miller
- **Activity code:** K07 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $69,390
- **Award type:** 3
- **Project period:** 2022-09-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10642998

## Citation

> US National Institutes of Health, RePORTER application 10642998, Improving Adverse Event Reporting on Cooperative Oncology Group Trials (3K07CA211956-05S1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10642998. Licensed CC0.

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