Alliance Data Innovation Lab
The healthcare ecosystem is rich with real-world clinical insights, yet much of this information remains fragmented electronic health records (EHRs) and health systems. The Alliance Data Innovation Lab, LLC (Data Lab) serves as an operational bridge between routine clinical care and oncology research. By developing, testing and validating next approaches to data standards and EHR integration, the Data Lab is working to transform routine collected clinical data into high-quality, research-ready information that can support clinical trials.
Through a collaborative network that includes nationally recognized cancer centers, the Alliance for Clinical Trials in Oncology, and Alliance Foundation Trials (AFT), the Data Lab is helping advance how oncology data are captured, standardized, shared, and used. This infrastructure is designed to improve trial efficiency and data quality while reducing the manual data entry required of research sites. By enabling more automated approaches to research data collection, the Data Lab aims to reduce administrative burden and support the timely availability of high-quality data for clinical research and regulatory purposes.
Current initiatives
The ICAREdata suite of projects is advancing a new approach to oncology data capture by leveraging mCODE (minimal Common Oncology Data Elements) standards to extract and structure high-quality data from the electronic health record. mCODE is an open-source data standard that establishes a common language for cancer information. By defining a core set of essential data elements, including patient characteristics, tumor information, treatments, side effects and disease status, mCODE helps different EHR systems capture and represent oncology information in a consistent way, making it more readily available for research.
ICAREdata is designed to turn routinely collected clinical information into a research resource that can support additional studies and new scientific questions. The initiative focuses on securely capturing the right data, at the right time, and in a standardized format, with appropriate consideration of patient understanding, privacy, and informed consent.
For more information, see the ICAREdata feasibility study published in Cancer in 2024.
ICAREdata-DIRECT is designed to reduce reliance on manually curated electronic case report forms (eCRFs) by extracting standardized data directly from clinical sources. The initiative is evaluating automated approaches to collecting key real-world clinical endpoints, including treatment and disease outcomes.
By reducing manual data entry, the project aims to integrate research data collection more seamlessly into routine clinical workflows while maintaining the quality and completeness needed for clinical research. Sites interested in participating can contact the project team at icaredata@alliancefoundationtrials.org to learn more.
Alliance Special Projects Award
This project is evaluating whether structured real-world data collected through EHRs can reliably support clinical data collection for key measures such as disease status, cancer stage, and patient outcomes.
The study compares mCODE-compatible EHR data with manually entered data in Rave electronic care report forms (eCRFs) at the Mayo Clinic and University of Wisconsin. By examining data availability, timelines, and concordance across the clinical trial timeline, the project aims to establish a framework for evaluating automated approaches to research data collection.
The longer-term goal is to develop an EHR-to-electronic data capture (EDC) implementation roadmap that can help reduce site burden and support broader adoption of standardized data approaches across the Alliance
The Alliance Participant Engagement Portal (PEP) is a web-based tool designed to support communication and engagement with clinical trial participants during and after their participation in a study.
Through a secure, bidirectional platform, participants can provide information through digital surveys, including demographic information and social determinants of health, while receiving trial-specific communications, study updates, and resources from the research team.
The Alliance PEP is currently being used in select Alliance trials, with efforts underway to expand its use across a broader portfolio of clinical studies. For more information about the portal, contact the portal team at pep.info@alliancepep.org or read the 2026 article in JNCI Cancer Spectrum.
More information
The Alliance Data Lab team shares findings through peer-reviewed publications that contribute to the growing body of research on automated data collection, standardized oncology data, real-world data, and digital participant engagement.
- Digitally Engaging Participants in Cancer Clinical Trials: Design and Pilot of the Alliance Participant Engagement Portal (PEP). Crossnohere NL, Campbell N, Paskett ED, Wood ME, et al. (2026). JNCI Cancer Spectrum, 10(3), pkag038. Read Publication
- Challenges in Automating Extraction of Real-World Radiographic Images and Adverse Events: Lessons From the ICAREdata Initiative. Piantadosi S, Campbell N, Chow S, Elrahi C, et al. (2025). JCO Clinical Cancer Informatics, 9, e2400319. Read Publication
- Integrated Electronic Health Record Tools to Access Real-World Data in Oncology Research. Casagni M, Llewellyn N, Kokolus M, et al. (2024). JAMIA Open, 7(4), ooae144. Read Publication
- Feasibility of Structuring Electronic Health Record Data to Facilitate Real-World Data Research: ICAREdata Methods Applied to Multicenter Cancer Clinical Trials. George S, Campbell N, Hillman S, et al. (2024). Cancer, 130(24), 4220-4230. Read Publication
- Transforming the Oncology Data Paradigm by Creating, Capturing, and Retrieving Structured Cancer Data at the Point of Care: A Mayo Clinic Pilot. Tevaarwerk AJ, Karam D, Gatten CA, et al. (2024). Cancer, 130(19), 3350-3360. Read Publication
- Steven Piantadosi, MD, PhD, FACCR
Alliance Associate Group Chair for Strategic Initiatives and Innovation
Director, Data Innovation Lab
ICAREdata Study Chair - Amye Tevaarkwerk, MD
Medical Director, Data Innovation Lab - Christopher Vetter, MD
Early Investigator, Data Innovation Lab - Selina L. Chow, MD
Executive Officer, Data Innovation Lab - Nancy Campbell, MSM, BSN, RN
Associate Director of Operations, Data Innovation Lab - Cassandra Elrahi
Senior Project Manager, Data Innovation Lab - Tatiana Armstrong
Project Coordinator, Data Innovation Lab