External Institution: Alliance NCTN Foundation
External Collaborators: Steven Piantadosi, MD, PhD; Michael Knopp, MD, PhD; Lawrence Schwartz, MD, Chair Alliance Imaging Committee
FDA Collaborators: Vaibhav Kumar, MD, FDA Lead; Catherine Lerro, PhD, MPH, FDA Co-Lead; Paul Kluetz, MD; Donna Rivera, PharmD, Msc; Steve Bird, MS, PhD
Project Start Date: October 2022
Regulatory Science Challenge
Analyses of RWD may address important questions about real world safety and effectiveness of medical products including the performance of oncology treatments among patients who are underrepresented in clinical trials. A better understanding of how safety and imaging data are captured within electronic health records is needed to realize this goal.
The ICAREdata study, conducted by the Alliance for Clinical Trials in Oncology, seeks to enable clinical oncology research by gathering high-quality RWD collected during routine clinical care. This project focuses on understanding the availability of imaging and adverse event data in the electronic health record (EHR) to improve our understanding of the efficacy and safety of oncology medical products. This project is a methodological proof of concept to determine whether imaging endpoints and treatment-emergent adverse events can be constructed from clinical trials and eventually from routine clinical care data.
Project Description and Goals
The specific aims of this project are to:
1. Develop and test methods to centrally access imaging files collected during routine clinical care for patients participating in clinical trials.
This will include identification of image files required to assess RWD endpoints, development and implementation of methods for automated transfer of these files, and testing the image file collection tool in Alliance clinical trials.
2. Develop and test new approaches for capturing treatment-emergent adverse events (AE) using data collected during routine clinical care to understand the safety of oncology medical products.
This involves defining a core set of EHR data elements collected during routine clinical care that can be used to identify treatment-emergent adverse events (TEAEs) for oncology research (ehrAE), and developing a method for collecting ehrAE data elements.
- OCE Scientific Collaborative
- FDA Broad Agency Announcement: Frequently Asked Questions for Oncology Researchers
- OCE-Funded Active Extramural Research Projects