About Alliance Data Innovation Lab, LLC
The Alliance Data Innovation Lab, LLC focuses on validation and data standards and technologies to assess data within the electronic health records used in clinical trials. 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 Project
The goal of the ICAREdata® project is 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 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 are used.
This use-case is important to the overall ICAREdata initiative because it introduces mCODE standards into the EHR of multiple institutions and engages a network of Alliance collaborators who are willing to develop and test this new standard.
Alliance Participant Engagement Portal (PEP)
Alliance PEP is an innovative web-based tool that was launched by the Alliance Data Innovation Lab. PEP is used to keep clinical trial participants engaged at key touch points throughout their enrollment 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, PEP surveys give the 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 as well as partnering with other clinical trials. Additional information or questions about PEP can be sent to pep.info@alliancepep.org.
Visit 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
ICAREdata® Adverse Event Reporting
The ICAREdata Adverse Event Reporting use case tests an mCODE-compatible structured data model for Common Terminology Criteria for Adverse Events (CTCAE) embedded within the EHR. This data model includes mapping of existing data elements to mCODE, and a gap analysis to detail data elements not already included in mCODE. It also develops and tests methods of collecting CTCAE data directly from the EHR of patients enrolled in Alliance clinical trials. Leveraging Epic’s adverse event capture tool embedded in the research module of the EHR and building FHIR interfaces for the data captured via this AE tool, our work can focus on usability, provider burden, and acceptance by providers, assessing mCODE integration and FHIR-enabled data transmission pathways for the data captured.
Real World Collection of Radiographic Images and Treatment-Emergent Adverse Event Data: Next Phase Development of ICAREdata Research Infrastructure
The goals of this work are to automate the collection of image files documenting treatment response for solid tumors, develop a data model and collection method for identifying treatment-emergent adverse events (TEAEs) using data collected during routine clinical care, and to initiate multi-site testing of ICAREdata methods using the EHR to collect clinical data with quality that is sufficient to support regulatory decision-making in oncology.
With the addition of these new data collection capabilities, Alliance will be ready to launch clinical trial generalizability studies for oncology treatment and cancer control indications. These studies will compare results from randomized clinical trials (RCTs) to those obtained from concurrent prospective observational studies of patients with the same disease who are not enrolled on a RCT. Consistent use of ICAREdata collection methods for both RCTs and non-experimental studies will produce RWD appropriate for accurate inferences that guide clinical care and support post-market active surveillance for new therapeutic agents.
Our Team
Steven Piantadosi, MD, PhD
Alliance Associate Group Chair for Strategic Initiatives and Innovation
Director of the Data Innovation Lab
ICAREdata Study Chair
Selina L. Chow, MD
Executive Officer
schow@alliancenctn.org
Nancy Campbell, RN, MSM
Associate Director of Operations
ncampbell@alliancefoundationtrials.org
Cassandra Elrahi
Senior Project Manager
celrahi@alliancefoundationtrials.org
Tatiana Armstrong
Project Coordinator
tarmstrong@alliancefoundationtrials.org
