Open Knowledge International is thrilled to announce that the OpenTrialsFDA team is presenting its prototype today at the BD2K Open Data Science Symposium in Washington, DC as finalist for the Open Science Prize. The Open Science Prize is a global science competition to make both the outputs from science and the research process broadly accessible. From now until 6 January 2017, the public is asked to help select the most promising, innovative and impactful prototype from among the six finalists – of which one will receive the grand prize of $230,000.

OpenTrialsFDA is a collaboration between Dr. Erick Turner (a psychiatrist-researcher and transparency advocate), Dr. Ben Goldacre (Senior Clinical Research Fellow in the Centre for Evidence Based Medicine at the University of Oxford) and the team behind OpenTrials at Open Knowledge International.

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]. These are often just images of pages, so you cannot even search for a text phrase in them. OpenTrialsFDA scrapes all the relevant data and documents from the FDA documents, runs Optical Character Recognition across all documents, links this information to other clinical trial data, and now presents it through a new user-friendly web interface at fda.opentrials.net.

Explore the OpenTrialsFDA search interface

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 has been integrated into the OpenTrials database, so that the FDA reports are linked to reports from other sources, such as ClinicalTrials.gov, EU CTR, HRA, WHO ICTRP, and PubMed.

The prototype will provide the academic research world with important information on clinical trials in general, improving the quality of research, and helping evidence-based treatment decisions to be properly informed. Interestingly, the FDA data is unbiased, compared to reports of clinical trials in academic journals. Dr. Erick Turner explains: “With journal articles everything takes place after a study has finished, but with FDA reviews, there is a protocol that is submitted to the FDA before the study has even started. So the FDA learns first of all that the study is to be done, which means it can’t be hidden later. Secondly it learns all the little details, methodological details about how the study is going to be done and how it is going to be analyzed, and that guards against outcome switching.”

Dr Ben Goldacre says: “These FDA documents are hugely valuable, but at the moment they’re hardly ever used. That’s because – although they’re publicly accessible in the most literal sense of that phrase – they are almost impossible to search, and navigate. We are working to make this data accessible, so that it has the impact it deserves.”

Voting for the Open Science Prize finalists is possible through http://event.capconcorp.com/wp/osp: more information on OpenTrialsFDA is available from fda.opentrials.net/about and from the team’s video below.

Editor’s notes

Dr. Ben Goldacre

Ben is a doctor, academic, writer, and broadcaster, and currently a Senior Clinical Research Fellow in the Centre for Evidence Based Medicine at the University of Oxford. His blog is at www.badscience.net and he is @bengoldacre on twitter. Read more here. His academic and policy work is in epidemiology and evidence based medicine, where he works on various problems including variation in care, better uses of routinely collected electronic health data, access to clinical trial data, efficient trial design, and retracted papers. In policy work, he co-authored this influential Cabinet Office paper, advocating for randomised trials in government, and setting out mechanisms to drive this forwards. He is the co-founder of the AllTrials campaign. He engages with policy makers. Alongside this he also works in public engagement, writing and broadcasting for a general audience on problems in evidence based medicine. His books have sold over 600,000 copies.

Dr. Erick Turner

Dr. Erick Turner is a psychiatrist-researcher and transparency advocate. Following a clinical research fellowship at the NIH, he worked for the US Food and Drug Administration (FDA), acting as gatekeeper for new psychotropic drugs seeking to enter the US market. In 2004 he published a paper drawing researchers’ attention to the [email protected] website as a valuable but underutilized source of unbiased clinical trial data. Dissatisfied with the continuing underutilization of [email protected], he published a paper in the BMJ in order to encourage wider use of this trove of clinical trial data.

Open Knowledge International

https://okfn.org

Open Knowledge International is a global non-profit organisation focussing on realising open data’s value to society by helping civil society groups access and use data to take action on social problems. Open Knowledge International addresses this in three steps: 1) we show the value of open data for the work of civil society organizations; 2) we provide organisations with the tools and skills to effectively use open data; and 3) we make government information systems responsive to civil society.