The OpenTrialsFDA team is one of the three finalists for the Open Science Prize. This is a collaboration between Dr. Erick Turner, Dr. 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.
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 [email protected]FDA. OpenTrialsFDA extracts the relevant data from the FDA documents, link it to other clinical trial data and present it through this new user-friendly web interface. Any user can type in a drug name, and see all the places where this drug is mentioned in a FDA document. This information is also available via the OpenTrials API.
Unlocking the trove of FDA clinical trials data
Drug Approval Packages report the methods and results of all premarketing clinical trials, both published and unpublished. Interestingly, the FDA data is unbiased, compared to reports of clinical trials in academic journals. This is because FDA reviewers, unlike most academic journal reviewers and editors, have access to the original trial protocol and can spot and reject any attempts at post hoc changes to planned outcomes and statistical analyses. Therefore, a systematic review (SR) or meta-analysis (MA) based on FDA Drug Approval Packages, which includes unpublished and “unspun" trial results, will often conclude that the drug in question is less safe and/or less effective than what one would conclude from a conventional SR or MA based solely on the published literature.
Unfortunately, despite their high value, these FDA documents are notoriously difficult to access, aggregate, and search. The [email protected] website itself is not intuitive to navigate, and the reviews are stored as individual PDFs which, except for relatively new drugs, cannot be searched. As a consequence, they are rarely used by clinicians and researchers. OpenTrialsFDA will improve this situation, so that valuable information that is currently hidden away can be discovered, presented, and used to properly inform evidence-based treatment decisions.
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. 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.
The six finalists of the Open Science Prize presented their prototypes at the BD2K Open Data Science Symposium on 1 December 2016. Following a public voting period in December 2016, the team was voted as one of the top 3 finalists and is currently in the final round. This top 3 will undergo a final expert review process, after which the winner of the Open Science Prize will be announced in March 2017 to receive the grand prize of $230,000.
If you want to find out more about OpenTrialsFDA, please check our Frequently Asked Questions. You can also read up on the work in the series of blog posts we published in the months leading up to the prototype demonstration:
- : OpenTrialsFDA presents prototype as finalist for the Open Science Prize
- : OpenTrialsFDA: Jeppe Schroll on the value of regulatory data
- : OpenTrialsFDA: an interview with Erick Turner
Further details about the contents of the FDA website are available at http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/.