Alliance - Alliance Data Innovation Lab (2024)

Alliance - Alliance Data Innovation Lab (1)

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.


ICAREdata Project

Alliance - Alliance Data Innovation Lab (2)

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 - Alliance Data Innovation Lab (3)

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

Visit PEP at: for the A212102 MCED Biobank Study for the AFT57 Lung Cancer Study 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

Nancy Campbell, RN, MSM
Associate Director of Operations

Cassandra Elrahi
Senior Project Manager

Tatiana Armstrong
Project Coordinator

Alliance - Alliance Data Innovation Lab (2024)


What is NCTN? ›

The NCTN structure includes five U.S. Network groups and the Canadian Collaborating Clinical Trials Network.

What is NRG oncology? ›

NRG Oncology is a non-profit research organization.

Formed to conduct oncologic clinical research and to broadly disseminate study results for informing clinical decision making and healthcare policy.

What is EORTC? ›

The European Organization for Research and Treatment of Cancer (EORTC) is an international, non-profit, research organization dedicated to conducting, developing, coordinating, and stimulating basic and clinical research on cancer and related problems.

What is the Alliance Foundation for Clinical Trials in Oncology? ›

The Alliance for Clinical Trials in Oncology is a national clinical trials network sponsored by the National Cancer Institute (NCI) that consists of nearly 10,000 cancer specialists at hospitals, medical centers, and community clinics across the United States and Canada.

What is the structure of the NCTN? ›

The NCTN is composed of four adult cancer cooperative groups: SWOG (Southwest Oncology Group); the Alliance for Clinical Trials in Oncology (commonly known as the Alliance); ECOG-ACRIN (Eastern Cooperative Oncology Group and American College of Radiology Imaging Network) Cancer Research Group; NRG Oncology (National ...

What is the NCT number in clinical trials? ›

NCT Number: The National Clinical Trial number is an identification that assigns a study when it is registered. The NCT number is in the format “NCTXXXXXXXX”. Until an NCT number is assigned, the study is not registered.

Is NRG part of NCTn? ›

NRG Oncology (NRG) is one of five national cancer cooperative groups currently funded by the National Cancer Institute (NCI) as part of the National Clinical Trials Network (NCTN).

What is the largest oncology GPO? ›

ION Oncology Practice Network

AmerisourceBergen Specialty GPOs is the largest specialty group purchasing organization in the oncology field.

What does NRG do? ›

NRG Energy Inc (NRG) is an integrated energy company. It generates and supplies electricity. The company produces electricity using coal, natural gas, nuclear, oil, biomass, wind, and solar sources.

What is QLQ? ›

The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items.

What is QOL in oncology? ›

People living with cancer experience a variety of symptoms. Quality of life (QOL) is a major concern of patients with terminal cancer. Symptoms affect their QOL. Management of symptoms improves distress and QOL.

What is the full form of ECOG? ›

Eastern Cooperative Oncology Group (ECOG) Performance Status.

What are the problems with Oncology clinical trials? ›

Oncology clinical trials often have complex trial design due to their advanced precision medicine treatments. This can cause difficulties for many clinical research sites, ultimately leading to limitations on who might be eligible to participate, high rates of protocol deviations, and high dropout rates.

What does CTRI do? ›

We envision a world where everyone is trauma-informed.

That's why we offer training, consulting, and free resources that will help you address trauma, promote mental health, develop your counselling skills, and prevent violence.

What is the success rate of Oncology clinical trials? ›

Success rates varied by therapeutic area. The biggest upswings were for rare diseases (rising to 13.3%), oncology (10.4%) and neurology (10.8%). The biggest declines were in immunology (falling to 8.8%) and infectious diseases (1.3%).

Is NCI a database? ›

NCI Brain Neoplasia Data (Rembrandt Database ) integrates clinical and functional genomics data from clinical trials involving brain tumor patients and provides the ability to perform ad hoc querying, reporting and analysis across multiple data domains, including gene expression, gene copy number and clinical data.

What is the clinical trials network? ›

The Clinical Trials Network (CTN) framework consists of sixteen nodes, a Clinical Coordinating Center, and a Data and Statistics Center. This framework links a variety of treatment providers and patient populations throughout the country.

What are the NCI cooperative groups? ›

A group of researchers, cancer centers, and community doctors who are involved in studies that test new ways to screen, prevent, diagnose, and treat cancer.

What is ETCTN? ›

The Experimental Therapeutics Clinical Trials Network (ETCTN) was created to evaluate these therapies using a coordinated, collaborative, and inclusive team-based approach to early phase experimental therapeutic clinical trials.


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