Category: About LabKey

Decentralized clinical trials (DCTs) expand options for trial participation by populations who are unable to leave their homes as easily or frequently as is required for traditional clinical trials. They can also help clinical trials do a more thorough job of accessing diverse populations by reducing geographical barriers, increasing trial enrollment, and improving retention. DCTs can also assist in capturing participant-centric data outside of the medical setting such as medication adherence, exercise, quality-of-life metrics, and other pertinent data. Although decentralized clinical trials have recently taken the spotlight as a remedy to challenges brought on by the COVID-19 pandemic, they will likely continue to be a widely used tool in clinical trial studies. 

Mobile Apps for Decentralized Clinical Trials

Mobile apps in particular have the potential to increase the efficiency and reach of prospective studies. One notable example is FDA MyStudies. The FDA selected Harvard Pilgrim Health Care Institute (HPHCI) to lead the development of this mobile application to facilitate the collection of real-world data directly from patients to support decentralized clinical trials, observational studies, and registries. Harvard Pilgrim selected LabKey as their development partner tasked with building a secure back-end storage environment for collected data. LabKey was selected due to the platform’s flexible, science-specific architecture. With the project’s long-term goal of expanding the use of real-world data across research programs, the application framework needed to support a broad range of potential healthcare topics through configuration as opposed to requiring development for each new project. LabKey Server also stood out as an ideal solution because of the platform’s ability to handle PHI/PII data in a manner compliant with HIPAA and FISMA regulations. 

The primary goal of the project was to build an open-source reusable platform consisting of a mobile device application and patient data storage environment that fulfills the FDA’s regulatory needs regarding data security and traceability. Creating a platform that meets regulatory data security and privacy standards while remaining extensible to different types of studies and patient cohorts was central to the requirements and design of the platform. The FDA MyStudies platform can be used and rebranded for studies in other various therapeutic areas and has most recently been modified to enable contactless patient informed consent during the COVID-19 pandemic.

For more information on FDA MyStudies for decentralized clinical trials, please see below:

FDA MyStudies Case Study

Publication: The FDA MyStudies app: a reusable platform for distributed clinical trials and real-world evidence studies

Since the start of the COVID-19 pandemic, the urgent need to gather, harmonize and share data has been felt across the scientific research community. To meet this demand, the NIAID Immune Response Consortium developed the HGRepo Informatics Framework in partnership with LabKey. This informatics system centralizes unstructured and de-identified clinical data collected from 14 domestic and international hospital sites. Researchers are using this data to study host genetics, host response, and microbial genetics as they relate to COVID-19. Downstream data from their research includes gene expression data, single-cell multi-omics data, humoral signature data, serology and more. 

Support from LabKey

LabKey supports NIAID by providing a platform to link all of the generated data back to the original clinical, demographics, and phenotype data. By helping integrate, track and make data accessible for collaborative research and integrated analysis, LabKey is helping researchers to quickly get the most insight from the consortium research data. In short, LabKey Server provided a central data repository to provide standardization and structure to clinical data including:

• Definition of Dataset and Sample Properties
• Controlled Vocabularies 
• Categorical Data Groupings
• Reports and Views
• Automated update of links to Assay Data
• Calculated timeline durations for samples
• NIH SAML Authentication
• Folder & Role Permissions

Watch the HGRepo Presentation at LKUC 2020

At the 2020 LabKey User Conference,  Sandhya Xirasagar Ph.D., Lead, Clinical and Laboratory Informatics Section with NIAID and  Jason Barnett, Contract Lead, Medical Science and Computing, Inc. presented on the HGRepo Informatics Framework. Their presentation covers the informatics framework including the background and requirements for the scientific data management system, a demo of HGRepo and the future vision for the system. Watch below:

High throughput plate-based immunoassays such as ELISA and ELISpot are important tools in drug discovery, clinical trials, bioanalytical labs and immunological research. With the advancement of these assays into microplates and their relatively inexpensive nature, both of these assays are widely used globally to evaluate immune responses to a variety of antigens.

Because of their low price point and technology requirements, ELISA and ELISpot assays are often performed in a high-throughput manner which produces a large amount of data in a short time frame. To support the reproducibility of experiment results, teams need lab data management tools that are scalable enough to manage this high volume data in a controlled manner without causing research bottlenecks. LabKey Server provides support for efficient ELISA and ELISpot data management by:

Streamlining Data Management in the Laboratory

LabKey Server helps streamline the management of immunoassay and other laboratory data by:

• Automatically importing instrument files upon availability using LabKey file watchers
• Providing automated cleaning, validation, and transformation of data from laboratory instruments, databases and software
• Structuring experiment results in data grids that can easily be sorted, filtered, and queried

Tracking Data Provenance

LabKey provides scientists with mechanisms for capturing data provenance by:

• Offering users easy-to-understand graphical plate mapping tools
• Allowing users to add metadata about the antigen or immune-responder
• Providing the ability to calculate background and normalize data when appropriate
• Visualizing calibration curves or normalized spot counts for dependable analysis

Facilitating Lab Data Integration & Analysis

LabKey helps scientists integrate, analyze and share their ELISA and ELISpot data by:

• Allowing users to easily integrate their plate-based data with other related data
• Providing built-in visualization tools for live or snapshotted analyses
• Offering a mature permissions strategy for securely sharing data and analyses with collaborators

LabKey Server helps research teams efficiently manage lab data at scale.

Click here to request a demo.

Browse Human Immune System Data

The Human Immunology Project Consortium (HIPC) program was established by the NIAID Division of Allergy, Immunology, and Transplantation (DAIT) as part of the overall NIAID focus on human immunology. To support the data management, analysis, and research efforts of HIPC, ImmuneSpace was developed. This project is led by Dr. Gottardo of the Fred Hutchinson Cancer Research Center. 

Immune system related data, collected from over 100 studies at HIPC research centers, is available to the public in ImmuneSpace, developed in collaboration with LabKey. Well-characterized human cohorts are studied using a wide variety of tools including:

• Multiplex transcriptional, cytokine, and proteomic assays
• Multiparameter phenotyping of leukocyte subsets
• Assessment of leukocyte functional status

LabKey Server Support for HIPC

LabKey Server provides the underlying system to centralize data for securely publishing, aligning, and harmonizing datasets across what would otherwise be siloed study repositories. Shared datasets and extensible schemas help bring diverse data together in a way that it can be treated as a global data bank.

The research network data centralization solution offered by LabKey server is specifically designed to: 

• Bring together data from disparate studies, making the data centrally available 
• Align data structures to minimize manual processing and facilitate integration
• Provide quality control tools to validate and standardize data from contributors
• Create secure workspaces to curate data prior to sharing with a wider audience
• Facilitate exploration and analysis of of complete integrated datasets
• Visualize, analyze, and report on aggregated data using built-in plotting and reporting tools. For example, LabKey Server’s powerful integration with the R statistical programming environment supports presenting R script results as live reports within LabKey Server.

Explore the new HIPC Interface

The ImmuneSpace platform recently launched a new Data Finder interface which makes it easy for users to explore and analyze datasets from hundreds of studies. Developed in ReactJS, with consulting support from LabKey developers and designers, plus extensions to the APIs, this modern interface presents an intuitive browsing experience. LabKey’s integrations with analysis and visualization tools including RStudio help power unique solutions like the ImmuneSpace DataFinder. 

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Filter by patient characteristics, study focus, and even by the type and timeframe of data available. Dashboard graphics update in real time to guide you as you make selections.

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Identify your own cross-study participant group of interest and save it for deeper analysis.  Use the group as a basis for visualizations and analysis.

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Investigating hypotheses across this existing landscape of collected data can unlock new insights for future study and help you connect with research similar to your own. Filtered study details can be scanned in a card format, or sorted in any way you choose.

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Click Here to get started by registering for a free account.

Previously released as FDA MyStudies, COVID MyStudies is now available as a free platform to assist investigators in remotely and securely obtaining informed consent from patients for eligible clinical trials when face-to-face contact is not possible due to COVID-19 control measures.

“The agency is providing this resource after hearing that investigators were having difficulties obtaining informed consent for clinical trials when patients were in isolation rooms in health care facilities or could not travel to outpatient clinics,” noted the FDA. By obtaining consent from patients remotely, COVID MyStudies can help ensure that clinical trials related to COVID-19 are not unnecessarily delayed.

COVID MyStudies is available on the Apple App and Google Play stores. 

Before using the app, investigators must contact the FDA. If a pre-IND or IND number is available, it should be included in the preliminary contact email. Investigators will provide their informed consent documents to the COVID MyStudies team to be added to the app. They will then have a chance to review all informed consent documentation within the app before incorporating it into their trials.

LabKey for COVID MyStudies

Harvard Pilgrim Health Care Institute (HPHCI) was selected by the FDA to lead the development of the FDA MyStudies mobile app. HPHCI in turn selected LabKey Server as the supporting data management solution and Boston Technology Corporation (BTC) as the developer of the mobile interface.

The flexible architecture of LabKey Server and its ability to handle PHI/PII data in a manner compliant with HIPAA and FISMA regulations leant itself well to the COVID MyStudies project. The Registration Server utilized to manage electronic consent, authentication, preferences, and notifications, is built upon the LabKey Server platform.  LabKey also provided the HIPAA/FISMA hosting environment for the application. You can learn more about how LabKey supported the FDA MyStudies app by reading our case study.

Related Resources

COVID MyStudies Support Documentation – LabKey

COVID MyStudies Announcement – FDA

Contact the support team at FDAMyStudiesContact@harvardpilgrim.org

Contact FDA at CDERMedicalPolicy-RealWorldEvidence@fda.gov