- The FDA has introduced the new MyStudies app, which will collect real-world evidence through mobile devices and increase the diversity of information available for clinical trials and other healthcare research.
After conducting a successful pilot study with Kaiser Permanente, the FDA has decided to release the open source code and technical documents that will allow researchers and developers to customize the MyStudies app.
Stakeholders can adapt the tool to fit their clinical trial and real-world evidence needs, while also complying with the FDA’s regulations for data authenticity, integrity, and confidentiality.
For example, the app can allow patients to securely enroll in and contribute data to traditional clinical trials, pragmatic trials, and observational studies and registries. Researchers can customize the app to assess patient-reported outcomes, as well as patient reports of prescription and over-the-counter medication use.
“This digital platform enables developers to adapt our technology to advance new ways to access and use data collected directly from patients—with the necessary controls in place to ensure patient privacy,” said FDA Commissioner Scott Gottlieb, MD.
“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.”
The MyStudies app features a secure, partitioned data storage environment that can support multi-site trials. Additionally, the app can be shaped for different therapeutic areas and health outcomes, which will reduce development barriers for non-FDA users.
The FDA will release the source code for two versions of the app, including one built for Apple’s ResearchKit framework, and another built on the open source ResearchStack framework, which runs on Google’s Android.
The agency expects that the data captured by the MyStudies app will enhance clinical trials and ultimately improve health outcomes.
“Better capture of real-world data, collected from a variety of sources, has the potential to make our new drug development process more efficient, improve safety and help lower the cost of product development,” said Gottlieb.
“If done right, it can also help make sure doctors and patients are better informed about the clinical use of new products, enabling them to make more effective, efficient medical choices. This will ultimately help us achieve better outcomes, and safer and more efficient use of expensive technology.”
The launch of the MyStudies app follows a September blog post from Gottlieb, in which he discussed using new technology and real-world evidence to accelerate clinical trial efficiency and medical product development.
“Our longstanding goal for medical care is to ensure that the right drug or device is delivered to the right patient at the right time. This vision is increasingly possible with the innovative products that are becoming available. These new technologies offer transformative opportunities. But they also challenge the US Food and Drug Administration (FDA) to modernize its approach to evaluating new innovations,” he said.
“Real-world evidence can help answer questions that are relevant to broader patient populations or treatment settings where information may not be captured through traditional clinical trials.”
As part of that mission, Gottlieb said the agency was actively seeking to use real-world evidence to support regulatory decisions, including data from patients’ electronic health records (EHRs), registries, and claims and billing data. With the introduction of MyStudies, the FDA will build on its efforts to improve healthcare effectiveness and efficiency.