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The FDA MyStudies app

Experts has developed a mobile application and secure patient data storage platform – FDA MyStudies – to address privacy, engagement and extensibility challenges that exist in mobile clinical research.

Increasing study efficiency

In the US, most comparative effectiveness and drug safety research relies on electronic health records (EHRs) and healthcare claims data. However, these sources do not reliably capture information that is important to the conduct of such studies. For example, medication adherence outside the medical home. These data sources also do not capture patient perspective. This is critical for endpoints such as pain and quality of life. In order to fill these gaps, trials and studies that include patient-reported outcomes are often needed. Mobile apps have the potential to increase the efficiency of such studies.

There are several challenges that remain regarding the use of current mobile frameworks. Challenges exist around consent, privacy and security, compliance and sustained engagement, and also extensibility and support of multiple therapeutic areas in one app. To address these challenges, the FDA collaborated with Harvard Pilgrim Health Care Institute to coordinate the development of the FDA MyStudies platform.

FDA MyStudies app

In this paper, published in JAMIA Open, the researchers present their open-source reusable platform comprised of a mobile device application and patient data storage environment that addresses the discussed challenges. Their platform meets regulatory data security and privacy standards whilst remaining extensible to different types of studies and patient cohorts.

As a proof-of-concept, the team conducted a descriptive pilot study of the exposures and health outcomes among pregnant women. They were able to capture data that is not routinely in EHRs and link this with existing patient data. This provided a more wholistic view of the patient.

The app is capable of expanding the depth and diversity of patient-reported information available to support clinical research. This can be used either alone or in combination with other electronic data sources. The work also addresses a critical gap by enabling investigators and policymakers to incorporate the patient voice in critical public health research.

Image credit: By katemangostar – freepik

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