Built for Science: Data Management Tools for Immunotherapy

CAR T and other cellular immunotherapy trials are rapidly expanding worldwide due to their high success rates and continued scientific advancements that are helping generate new therapeutic targets. The development of these advanced immunotherapies requires extensive data collection and collaboration between research scientists, clinical teams, and trial subjects. In order to manage immunotherapy data efficiently and improve the feedback loop from current and ongoing trials many research teams are seeking out secure, web-based data management solutions in lieu of traditional paper based systems to manage their trial data.

LabKey is actively partnering with teams conducting immunotherapy trials to provide Server SDMS-based solutions to overcome a wide variety of challenges and accelerate their research, including:

Integrating Heterogeneous Immunotherapy Data

Cutting edge cellular immunotherapy trials rely on data generated at multiple sources often including the cellular manufacturing facility, the clinic gathering subject data, and research labs exploring the cellular profile of the therapy. Teams conducting CAR T and other immunotherapy trials need reliable bioinformatics software tools to integrate this heterogeneous data and provide a comprehensive view of the therapy’s efficacy and safety to clinicians and researchers.

Server SDMS helps immunotherapy research teams efficiently integrate heterogeneous data by providing:

• A data-aware study module that can recognize and integrate disparate vendor datasets, alias subjects and track visits by name or by date
• Built-in and customizable integration with electronic data capture systems and case report forms

Longitudinal Study Data Capture

Lengthy follow-up periods are typically required for subjects undergoing therapy involving genetically modified cells. Managing trial data over time in a secure and scalable manner quickly becomes very challenging for paper-based systems.

LabKey Server helps support the consistent collection and storage of longitudinal study data throughout the lifetime of a trial by providing:

• A configurable study progress report that allows trial staff to manage samples and tests, ensuring that every result is accounted for.
• The flexibility to customize and modify the system as the needs of the database grow and change, without compromising historic data.
• Professional support and services to ensure that the system is maintained throughout the life of the trial.

Explore this Longitudinal Study in LabKey Server SDMS

This example study compares various anti-retroviral (ARVs) treatment regimens by monitoring HIV-1 disease progression in 122 participants.

Compliant Collaboration

Sharing reports and data with collaborators improves research, innovation, and ultimately subject care. Maintaining compliance and having the ability to quickly share data and reports is an important topic to tackle in immunotherapy research where subject safety and care is the top priority.

LabKey Server improves reporting and collaboration amongst collaborators conducting immunotherapy trials by providing:

• Dynamic and static reporting tables and visualizations that can be shared as-needed
• Web-based access to a central platform for data sharing
• The ability to remove PHI fields or provide randomized IDs when sharing
  information with collaborators

User Presentation

Using Existing LabKey Modules to Build a Platform for Immunotherapy Clinical Trials

The Correlative Studies Laboratory (CSL), part of the Immunotherapy Integration Hub at Seattle Children’s, focuses on understanding how reprogrammed T cells react in each patient in terms of their persistence, functionality and efficiency at reducing tumor burden. This data, combined with manufacturing and clinical data generated during clinical trials, enable researchers to answer pressing questions with minimal time and resource investment.

In this presentation Olivia Finney, shares how the CSL is working with LabKey to integrate, analyze and securely share data in order to create a truly translational research model. Watch presentation >