FDA MyStudies for Decentralized Clinical Trials

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. 

FDA MyStudies 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 SDMS 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