ABOUT ALLIANCE DATA INNOVATION LAB, LLC

The Alliance Data Innovation Lab, LLC (Data Lab) focuses on validation of data standards and technologies to assess data within the electronic health records (EHRs) for use in clinical trials. The Data Lab provides the operational infrastructure to accomplish these efforts in collaboration with nationally recognized cancer centers and trials run by the Alliance for Clinical Trials in Oncology (Alliance) and Alliance Foundation Trials, LLC (AFT). Data Lab’s mission is to increase efficiency in the conduct of clinical trials, increase quality and standardization of data, reduce administrative and clinical burden, and expedite submission of clinical trials data to FDA and other key regulatory agencies.

CURRENT INITIATIVES

ICAREdata

The goals of ICAREdata® projects are to explore methods for collection of high-quality, complete, accurate, and computable data from the point of care suitable for use in oncology therapeutic development and clinical trials. ICAREdata initiatives use the EHR as a tool for collecting clinical trials data at the point of care by implementing data structures and data collection methods that improve data interoperability, decrease data heterogeneity, and minimize provider burden.

We engage a broad network of Alliance collaborators from academic and community-based sites who are willing to develop and test these new standards. ICAREdata initiatives will fundamentally transform data capture paradigm in clinical research through leveraging minimum accomplishing our ongoing mission-focused work.

ICAREdata-DIRECT
The primary goal of this initiative is to answer a clinical research question through direct extraction of data from the EHR instead of using traditional manually curated electronic case report forms (CRFs) This methodology will reduce site effort for data collection at the point of care, with minimal disruption to clinical workflow, thereby increasing the availability of standardized, structured data.

This project will assess real-world time to treatment failure and progression of disease for any solid tumor population. Participating sites can enable their EHR systems to allow data collection with direct, secure transmission to the Data Lab for statistical analysis. There will be no CRFs required for this project. 

For more information or to participate in this use-case, email the team at icaredata@alliancefoundationtrials.org.

Alliance Special Projects Award
Obtaining mCODE Structured Data Elements in Alliance Clinical Trials Using Electronic Health Record-Based Tools

This project aims to evaluate the use of structured real-world data (mCODE RWD) collected within the EHR as an alternative to traditional manual data curation for cancer clinical trials, focusing specifically on key metrics like cancer disease status, cancer Stage, and patient performance status.

The team will compare mCODE-compatible, EHR-aligned data with manually curated clinical trial data entered into Rave CRFs from two Alliance sites (Mayo Clinic and University of Wisconsin). We will assess data availability, timeliness of collection, and concordance with CRF data during and outside of clinical trial designated time points.

Based on study findings, the project will develop an EHR-to-EDC (Electronic Data Capture) implementation roadmap to streamline research data collection, reduce site burden, and support broader adoption of mCODE data standards across the Alliance network.

Alliance Participant Engagement Portal (PEP)

Alliance PEP is an innovative tool launched by the Alliance Data Innovation Lab. PEP helps keep clinical trial participants engaged at key touch points during and after their enrollment in Alliance clinical trials. The bidirectional communication of PEP is a pillar of its functionality and capabilities. Registered participants can complete surveys and receive trial specific communications and updates. Moreover, surveys distributed through PEP give participants the ability to self-report their demographic and social determinants of health information. PEP is partnered with several Alliance trials and is working on expanding its capabilities by partnering with other clinical trials. Additional information or questions about PEP can be sent to pep.info@alliancepep.org.

DATA LAB PUBLICATIONS

  • George S, Campbell N, Hillman S, et al. (2024). Feasibility of structuring electronic health record data to facilitate research: ICAREdata methods applied to multicenter cancer clinical trials, Cancer 2024; 1-11. https://doi:10.1002/cncr.35528
  • Tevaarwerk AJ, Karam D, Gatten CA, et al. (2024). Transforming the oncology data paradigm by creating, capturing, and retrieving structured cancer data at the point of care: a Mayo Clinic pilot. Cancer. 2024;1‐11. https://doi:10.1002/cncr.35304
  • Casagni, M, Llewellyn N, Kokolus M, et al. (2024). Integrated electronic health record tools to access real-world data in oncology research, JAMIA Open, Volume 7, Issue 4, December 2024, ooae144, https://doi.org/10.1093/jamiaopen/ooae144
  • Piantadosi S, Campbell N, Chow S, et al. (2025). Challenges in automating extraction of real-world radiographic images and adverse events: Lessons from the ICAREdata initiative. JCO Clinical Cancer Informatics. 2025. https://ascopubs.org/doi/pdf/10.1200/CCI-24-00319
  • Crossnohere NL, Campbell N, Paskett ED, et al. Digitally engaging participants in cancer clinical trials: design and pilot of the Alliance Participant Engagement Portal (PEP). JNCI Cancer Spectrum. Published online April 11, 2026. https://doi:10.1093/jncics/pkag038

OUR TEAM

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