The Food and Drug Administration has launched a new mobile app for capturing real-world data from patients to inform and assist clinicians in making regulatory decisions.

Partnering with Kaiser Permanente on a pilot study, the FDA evaluated the functionality and engagement of its MyStudies app. Following the success of the trial, the agency has released the open source code and technical documents for customizing the app to meet individualized needs.

“It is estimated that patient-reported outcomes will be increasingly included in clinical studies submitted for regulatory review, as contemplated under 21st Century Cures. It is expected that the MyStudies app will aid researchers and industry by expanding the range of endpoints and making it more convenient for patients to participate in clinical research,” Kristofer Baumgartner, an FDA spokesperson, told HCB News. “Patient data provided through the app, when linked to existing electronic health data or other data sources from clinical trials or registries, will promote efficiencies in drug development and safety.”
Real world data can be captured from a variety of sources, including EHRs, claims, billing activities, and product and disease registries. Patient-generated data is also accessible from home-use settings and other sources, such as mobile devices.

Customization of the app will allow clinicians to collect greater amounts and more diverse health information deemed necessary for clinical trials and studies, as well as directly capture the perspective of patients. Patients can also securely enroll in and provide data to trials, studies and registries.

Data will be stored in a secure Federal Information Security Act-compliant cloud-based storage environment operated by LabKey, with only authorized research staff at the health insurance plan data partner or clinical trial capable of seeing combined electronic health and app data. De-identified patient-provided data will be accessible to storage environment administrators.

The data storage environment also supports auditing necessary for compliance with 21 CFR Part 11 and the Federal Information Security Management Act, allowing it to be used for trials under Investigational New Drug oversight.

A specific example of the app’s use includes being able to customize and administer questionnaires to assess patient-reported outcomes, symptom scale, and patient reports of prescription and over-the-counter medication use.

Such a capability and others are possible by making adaptations using the open source code, developed in collaboration with Harvard Pilgrim Health Care Institute, LabKey and Boston Technology Corporation. In addition, the tools work in compliance with FDA regulations and guidance for data authenticity, integrity and confidentiality.

“Patients can securely enroll and participate in large-scale pragmatic clinical trials or registries involving multiple health care systems or data sources,” said Baumgartner. “The agency expects that the MyStudies app will aid researchers and industry in collecting real-world patient-level data and that these data, when linked to existing electronic health data, will promote efficiencies in drug development and drug safety monitoring processes.”

Funding for the project was provided by a grant from the U.S. Department of Health and Human Services’ Patient Centered Outcomes Research Trust Fund.

Health IT Homepage