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 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 electronic health record (EHR) as a tool for collecting high quality clinical trials data by implementing data structures and data collection methods that improve data interoperability, decrease data heterogeneity, and minimize provider burden. The overarching goals of ICAREdata initiatives are to develop and apply methods for securely collecting the right data at the right time in the right format, with the patient’s understanding of and consent for how their data will be used.

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 Common Oncology Data Elements (mCODE) standards in the EHR.

ICAREdata-DIRECT
The primary goal of this latest 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 (eCRFs) 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 data.

Focusing on metastatic breast cancer patients, this project will assess real-world time to treatment failure and progression of disease. Participating sites can enable their electronic health record systems to allow data collection with direct transmission to the Data Lab for analysis. There will be no case report forms required for this project. The outcomes of this work can transform the paradigm of clinical research!
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 electronic health record (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 data with manually curated clinical trial data entered into Rave eCRFs from two Alliance sites (Mayo Clinic and University of Wisconsin). We will assess the data’s availability, timeliness of collection, and concordance with eCRF 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 web-based 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. 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. 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

OUR TEAM

Steven Piantadosi, MD, PhD, FACCR  
Alliance Associate Group Chair for Strategic Initiatives and Innovation
Director, Data Innovation Lab
ICAREdata Study Chair
spiantadosi@bwh.harvard.edu

Amye Tevaarwerk, MD
Medical Director, Data Innovation Lab
tevaarwerk.amye@mayo.edu

Selina L. Chow, MD                
Executive Officer        
schow@alliancenctn.org

Nancy Campbell, MSM, BSN, RN              
Associate Director of Operations       
ncampbell@alliancefoundationtrials.org

Cassandra Elrahi                     
Senior Project Manager   
celrahi@alliancefoundationtrials.org

Tatiana Armstrong     
Project Coordinator   
tarmstrong@alliancefoundationtrials.org