About Alliance Data Innovation Lab, LLC
The Alliance Data Innovation Lab, LLC (Data Lab) focuses on validation and data standards and technologies to assess data within the electronic health records used in clinical trials. The Data Lab provides 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 the ICAREdata® project are to explore methods for collection of high-quality, complete, accurate, and computable data from the point of cancer care suitable for use in oncology therapeutic development and clinical trials. The ICAREdata initiative aims to overcome challenges of using the electronic health record (EHR) as a method for obtaining high quality clinical trials data by developing data structures and data collection methods that accurately report clinical trials data while minimizing provider burden. The overarching goals of the ICAREdata initiative are to develop and apply methods to securely collect the right data at the right time in the right format, with the patient’s understanding of and consent for how the data will be used.
The use-cases under the overall ICAREdata initiative are integral to fundamentally transforming data capture in the clinical research through leveraging minimum Common Oncology Data Elements (mCODE) standards into the EHR of multiple institutions. We engage a network of Alliance collaborators who are willing to develop and test this new standards.
ICAREdata-DIRECT
Can a clinical research question by direct extraction of data from the EHR instead of using traditional case report forms? This is the primary goal of the Data Lab's latest initiative, ICAREdata-DIRECT. This use-case intends to lower site-lewl effort for data collection at the point of care with minimal impact to clinical workflow, therefore increasing overall availability of standardized data.
Focusing on metastic 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 form entry required for this project. The outcomes 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 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 and AFT 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.
Learn more about PEP at:
https://mced.alliancepep.org for the A212102 MCED Biobank Study
https://aft57.alliancepep.org for the AFT57 Lung Cancer Study
https://intercon.alliancepep.org for the A052101 Mantle Cell Lymphoma Study
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
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
