The US Food and Drug Administration (FDA) has launched the MyStudies App, a mobile application aimed at supporting the collection of “real world” data and evidence for medical use.1,2
“There are a lot of ways that we can use real world evidence to help inform regulatory decisions around medical products as the collection of this data gets more widespread and reliable,” said FDA Commissioner Scott Gottlieb, MD, in a statement.
The MyStudies App resulted from a successful pilot study conducted in partnership with Kaiser Permanente that measured the functionality and engagement of MyStudies. Following the positive results, the FDA will release both the open source code and technical documents that will “allow researchers and developers to customize and use the FDA’s newly created MyStudies app to expand the diversity of health information available for clinical trials and studies, while directly capturing the perspective of patients.”
The app allows patients to securely enroll and participate in a variety of clinical and pragmatic trials and observational studies. The open source code is compatible with both Apple iOS and Android devices, and software developers will have the opportunity to access this code and improve upon the available capabilities.
“Our hope is that the collection of more real world data directly from patients, using a secure app, will lead to more efficient product development and assist with safety monitoring,” Dr Gottlieb concluded.
- FDA launches new digital tool to help capture real world data from patients to help inform regulatory decision making [news release]. Silver Springs, MD: US Food and Drug Administration; November 6, 2018.https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm625228.htm. Accessed November 7, 2018.
- FDA’s MyStudies Application (App). US Food and Drug Administration. https://www.fda.gov/Drugs/ScienceResearch/ucm624785.htm. Published November 6, 2018. Accessed November 7, 2018.