FDA releases open source code

Nov. 8, 2018

The US Food and Drug Administration (FDA) on Nov. 6 released computer code and a technical roadmap to allow researchers and app developers to use the agency’s newly created app that helps link real world data with electronic health data supporting clinical trials or registries.

FDA said the app and patient data storage system can be reconfigured by organizations conducting clinical research and can be rebranded by researchers and developers who would like to customize and rebrand it.

Among the features of the app is a secure data storage environment that 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 also configurable for different therapeutic areas and health outcomes, according to FDA, which reduces software development hurdles for non-FDA users. And the data storage environment is partitioned to support multi-site trials or “distributed database” studies, the agency added.

“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,” FDA said.

Open source code is being released for two versions of the app: one on Apple’s ResearchKit (iOS) framework, and the other on the open source ResearchStack framework, which runs on Google’s Android.

Regulatory Focus has the article

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