FDA recently launched a new app designed to allow researchers to easily collect real-world evidence in the form of EHR patient data, claims and billing information, and patient-generated health data through patients’ mobile devices.
The app—called MyStudies—enables researchers to gather real-world evidence from a variety of sources and use this data in clinical trials and studies. These clinical trials and observational studies may help to inform regulatory decisions in the future as researchers gain a more comprehensive understanding of how new drugs and medical products affect patients.
“There are a lot of new 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.
“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,” he continued.
FDA partnered with Kaiser Permanente to carry out a pilot study measuring the functionality and effectiveness of the MyStudies app. After achieving success with the new tool, FDA is releasing the open source code and technical documents that support MyStudies to allow researchers and health IT developers to customize the app to fit their own needs and objectives.
“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,” said Gottlieb. “This will ultimately help us achieve better outcomes, and safer and more efficient use of expensive technology.”
By allowing researchers and developers to customize and use the MyStudies app, FDA intends to expand the diversity of health data available for clinical trials and studies while also capturing the unique perspective of patients.
Making the open source code available to users allows developers to adapt the app to support their specific clinical trials while also remaining compliant with FDA regulations.
“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,” concluded Gottlieb.
Users can customize the app to allow patients to securely contribute EHR data or patient-generated health data to clinical trials, pragmatic trials, observational studies, and registries. Users can also configure the app to allow patients to enroll in clinical trials or administer questionnaires to assess patient-reported health outcomes, symptom scales, or prescription medication use.
Health IT developers are encouraged to improve upon the app’s capabilities using the open source code. The code is being released for a version of the app built on Apple’s ResearchKit (iOS) framework, as well as a version built on the open source ResearchStack framework that runs on Google’s Android.
“These enhancements will simplify configuration for researchers and improve the experience for participants,” stated FDA.
FDA’s decision to release versions of the app that are compatible with iOS and Android devices aligns with the growing industry trend of tech giants including Google, Apple, and Microsoft becoming increasingly involved in the healthcare sector.
Apple is currently making a big splash with its Health Records EHR data viewer, released in early 2018.
More than 80 health systems have joined the Health Records beta program, allowing patients to access their complete health information in a single view through iOS devices.
The app uses Fast Healthcare Interoperability Resources (FHIR) to aggregate patient health data from several sources and present the information to patients in a user-friendly interface.