The U.S. Food and Drug Administration (FDA) is posting computer code and a technical roadmap that will allow researchers and developers to customize and use the FDA’s newly created MyStudies app.

What MyStudies App is

The App is designed to facilitate the input of real world data directly by patients which can be linked to electronic health data supporting traditional clinical trials, pragmatic trials, observational studies and registries.

The storage system can be reconfigured by organizations conducting clinical research.  The app bore the FDA brand while its functionality was tested in a pilot study, but it can now be rebranded by researchers and developers who would like to customize and rebrand the app.

FDA MyStudies App important features

  • The data storage environment is secure and supports auditing necessary for compliance with 21 CFR Part 11 and the Federal Information Security Management Act, so it can be used for trials under Investigational New Drug oversight
  • The app is configurable for different therapeutic areas, and health outcomes, which reduces software development hurdles for non-FDA users
  • The data storage environment is partitioned to support multi-site trials or “distributed database” studies
  • The code for MyStudies will be open source so software developers can improve upon its capabilities

Real world data

Real world data are assuming an increasingly central role within the care system, as they can:

  • optimize the organization of health systems and the provision of services
  • capture and process the actual data on the use of drugs among the general population.

Precisely to this last area, the possible use of real world data is also used to conduct clinical studies with less or not selected patients’ cohorts compared to traditional designs of randomized trials.

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