FDA invests in drug safety analysis platform

FDA signs research agreement to build drug safety analysis platform

To improve the speed and quality of analysis of drug safety analysis, the Food and Drug Administration is partnering with Commonwealth Informatics to make it easier for its reviewers detect and investigate safety signals during new drug application reviews and post-market drug monitoring.

Usually, the complexity of clinical data requires analysis by a variety of specialists, with additional time allocated for changes or errors. The company’s Commonwealth Clinical Data Analytics (CCDA) collaborative platform, however, uses a graphical interface that works with diverse data sources, eliminating the need for traditional programming and streamlining the process for both clinicians and analysts.

The two-year contract between the FDA and Commonwealth aims to enhance the CCDA platform to improve the speed and quality of data reviews and the critical analysis of drug safety data.

The initial plan with FDA is for Commonwealth to host the program using its own cloud infrastructure, and to run the analytics tool on openFDA’s adverse event data, according to Commonwealth’s Sheila Rocchio. Eventually, the FDA will host the program internally, she added.

Through the contract, the FDA will provide scientific, clinical and statistical support to help improve the platform, which will ultimately improve the speed, quality and transparency of analyzing drug safety analysis to inform better regulatory decisions.

About the Author

Amanda Ziadeh is a former reporter/producer for GCN.


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