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FDA MyStudies

An app to further the advancement of clinical research.

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The U.S. Food and Drug Administration (FDA) is expanding the reach of clinical research with a new app called MyStudies. The app can be customized and rebranded for any study using open source code.

The MyStudies app allows secure data to be collected directly from patients and has the potential to make the drug development process more efficient and focused on patients.

After successful outcomes from a pilot study conducted in partnership with Kaiser Permanente, the FDA has released the open source code and technical documents that allow researchers and developers to customize and use MyStudies. The code was recently updated in conjunction with rebranding and configuration for use in the LimitJIA clinical trial supported by the Patient Centered Outcomes Research Institute and a registry supported by the Crohn’s and Colitis Foundation.

The MyStudies app incorporates key features and functionality to enable successful study app development and execution. It allows for customized configuration to support its use across various conditions and health outcomes. If necessary for your study, the app and its secure data storage can be operated in a manner consistent with audits and compliance with 21 CFR Part 11 and the Federal Information Security Management Act.

Similar to the ResearchKit framework, the MyStudies project is open source, which means developers can continue to enhance the current feature set through contributions to the project on GitHub.

Apple Researc‪h‬

Delivering studies at scale.

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In November, Apple released its new Research app built to revolutionize how health research is conducted. Three new studies, available on the Research app, will explore new areas of medical research. The app and associated studies leverage the ResearchKit framework to the fullest by taking advantage of features from ResearchKit’s core modules: Consent, Surveys, and Active Tasks.

Since its launch in 2015, ResearchKit development has laid the foundation for studies to be conducted on a mobile platform that allows people to participate in research studies from the comfort of their own home. ResearchKit has established the building blocks of mobile studies through features that enable the ability to quickly capture informed consent from participants, easily generate questionnaires, and deliver active tasks to engage participants in the research study. All of these modules have contributed to the launch of numerous studies around the globe that were not previously possible.

The continued development and growth of the ResearchKit framework from both Apple’s engineering teams and the amazing ResearchKit community contributions are now being utilized through Apple Research app, a testament to the devotion and commitment to health research at Apple. User experience and engagement has always been a top priority at Apple, and ResearchKit will continue to support and elevate the experience for participants based on feedback from our community and these new studies.