Today the U.S. Food and Drug Administration is posting links to computer code and a roadmap that will allow researchers and developers to customize and use the newly created MyStudies app. Patients can securely enroll and participate in large scale pragmatic clinical trials or registries involving multiple health care systems or data sources. 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. The MyStudies app is also capable of supporting clinical trials that comply with FDA guidance and regulations regarding data authenticity, integrity, and confidentiality (21 CFR Part 11 compliant clinical trials).
There are two versions of the app. One is built on the Apple ResearchKit (iOS) framework, and the other is built on the open source ResearchStack framework, which runs on Google’s Android.
The MyStudies app is an example of FDA using technology to bridge initiatives and respond to stakeholder feedback. It can expand the clinical information available for clinical trials and studies, while directly capturing the perspective of patients.
FDA’s Center for Drug Evaluation and Research led this effort and received a grant from the Patient Centered Outcomes Research Trust Fund. The open source code that serves as the foundation of the MyStudies app, as well as specifications for a secure patient data storage environment, were developed through a collaboration with Harvard Pilgrim Health Care Institute, LabKey, and Boston Technology Corporation. Kaiser Permanente Washington Health Research Institute performed a pilot study of medication exposure and health care outcomes.
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