OpenTrialsFDA: Unlocking the trove of clinical trial data in Drugs@FDA

OpenTrialsFDA works on making clinical trial data from the FDA (the US Food and Drug Administration) more easily accessible and searchable. Until now, this information has been hidden in the user-unfriendly Drug Approval Packages that the FDA publishes via its dataportal Drugs@FDA.

OpenTrialsFDA extracts the relevant data from the FDA documents, links it to other clinical trial data and presents it through this new user-friendly web interface.

This is a collaboration between Drs. Erick Turner, Ben Goldacre and the OpenTrials team at Open Knowledge International. The work is closely related to the OpenTrials project, which aims to locate, match, and share all publicly accessible data and documents, on all trials conducted, on all medicines and other treatments, globally.

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Explore the OpenTrialsFDA search interface now!

The OpenTrialsFDA prototype

The team has scraped the FDA website and extracted the relevant information from the PDFs through a process of OCR (optical character recognition). Through this new OpenTrialsFDA interface, users will be able to explore and discover the FDA data.Any user can type in a drug name, and see all the places where this drug is mentioned in an FDA document. Users can also access, search and present this information through the application programming interfaces (APIs) the team will produce. In addition, the information will be integrated into the OpenTrials database, so that the FDA report can be linked to reports from other sources, such as ClinicalTrials.gov, EU CTR, HRA, WHO ICTRP, and PubMed.

More here from the OpenTrialsFDA team on the implications of the prototype

 

In May 2016, OpenTrialsFDA was selected as one of six finalists for the Open Science Prize. The finalists showcased their prototypes at the BD2K Open Data Science Symposium on 1 December 2016. During the online voting period which ran until 6 January 2017, the public selected OpenTrialsFDA as one of the top 3 finalists. After the judging by an expert panel, the team was placed as a runner-up alongside MyGene2, with Real-Time Evolutionary Tracking for Pathogen Surveillance and Epidemiological Investigation being declared the winner of the grand prize of $230,000.

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What’s next for OpenTrialsFDA?

The search engine will continue to exist at fda.opentrials.net – it currently indexes over 55,000 FDA approval documents and where possible links to clinical trials on OpenTrials (a few examples). While development on OpenTrialsFDA has stopped for the moment (we’re focusing on the main OpenTrials explorer) there are a number of ways you can help support the project:

Further Resources

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Visit fda.opentrials.net for more information on how OpenTrialsFDA will improve access to FDA data.
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Interview with Dr Erick Turner, member of the OpenTrialsFDA team, on the importance of making FDA data more usable.
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Interview with Dr Jeppe Schroll on the importance of including data from regulatory agencies in systematic reviews.