OpenTrialsFDA is a collaboration between 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.
OpenTrialsFDA will increase access, discoverability and opportunities for re-use of a large volume of high quality information currently hidden in user-unfriendly Federal Drug Administration (FDA) drug approval packages. The prototype will enable academics, clinicians and researchers working with clinical trials to search and access the FDA information on clinical trials via a user-friendly web interface. The team will also produce application programming interfaces (APIs) allowing third party platforms to access, search, and present the information, thus maximising discoverability, impact, and interoperability.
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, by an evidence base that is more complete and less vulnerable to “spin”.
The finalists, announced at the 7th Health Datapalooza Conference in Washington, D.C., were selected out of 96 multinational, interdisciplinary teams representing 450 innovators from 45 countries. The Open Science Prize is a collaboration between the National Institutes of Health and the Wellcome Trust, with additional funding provided by the Howard Hughes Medical Institute of Chevy Chase, Maryland.
Final prototypes will be submitted on December 1, 2016, and will be demonstrated at an Open Science Prize Showcase to be held in early December 2016. The public will also be invited to consider and vote online for their favourite prototype. The ultimate Open Science Prize winner is expected to be announced in late February or early March 2017.
Contact: [email protected]
@opentrials
https://www.openscienceprize.org/res/p/finalists/
https://fda.opentrials.net/
]]>
The paper, ‘OpenTrials: towards a collaborative open database of all available information on all clinical trials’ outlines the ambitions of the OpenTrials project.
Read more about OpenTrials in Ben Goldacre’s guest blog on BioMed Central: OpenTrials: what, why and how?
OpenTrials is a collaborative and open linked database for all available structured data and document on all clinical trials, threaded together by an individual trial. Where other projects have set out manually and perfectly curate a narrow range of information on a smaller number of trials, we aim to use a broader range of techniques and attempt to match a very large quantity of information on all trials. We are currently seeking feedback and additional sources of structured data.
The paper gives an overview of:
Follow the project on Twitter: @opentrials
Are you interested in being involved in the project as a:
Sign up via our website: https://opentrials.net/
]]>The Community Manager for OpenTrials will have a working understanding of what clinical trials are, how they are run, and how they are reported; the different kinds of documents and data associated with clinical trials; and the current barriers to accessing them.
We are looking for someone self-driven and organised with expert community management and communications skills, who has the ability to engage with community members at all levels – from policy makers to developers working in the health sector.
This is a part-time position (2 days per week) available immediately. This is a fixed term contract of six months with the possibility of extension. Early application is encouraged, as we are looking to fill the position as soon as possible. The vacancy will close when we find a suitable candidate
]]>With thanks to the Nature Publishing Group.
Want to get involved in OpenTrials?
Sign up here: https://opentrials.net/
Follow us: @opentrials
Or email us directly [email protected]
Open Trials will aggregate information from a wide variety of existing sources in order to provide a comprehensive picture of the data and documents related to all trials of medicines and other treatments around the world. Conducted in partnership with the Center for Open Science and supported by the Center’s Open Science Framework, the project will also track whether essential information about clinical trials is transparent and publicly accessible so as to improve understanding of whether specific treatments are effective and safe.
“There have been numerous positive statements about the need for greater transparency on information about clinical trials, over many years, but it has been almost impossible to track and audit exactly what is missing,” Dr. Goldacre, the project’s Chief Investigator and a Senior Clinical Research Fellow in the Centre for Evidence Based Medicine at the University of Oxford, explained. “This project aims to draw together everything that is known around each clinical trial. The end product will provide valuable information for patients, doctors, researchers, and policymakers—not just on individual trials, but also on how whole sectors, researchers, companies, and funders are performing. It will show who is failing to share information appropriately, who is doing well, and how standards can be improved.”
Patients, doctors, researchers, and policymakers use the evidence from clinical trials to make informed decisions about which treatments are best. But studies show that roughly half of all clinical trial results are not published, with positive results published twice as often as negative results. In addition, much of the important information about the methods and findings of clinical trials is only made available outside the normal indexes of academic journals.
“This project will help to shed light on both good and bad practices by the sponsors of clinical trials,” Stuart Buck, LJAF Vice President of Research Integrity, explained. “If those sponsors become more transparent about their successes and failures, medical science will advance more quickly, thus benefitting patients’ health.”
“We are thrilled to partner with Open Knowledge on the use of the Open Science Framework (OSF) for this project. Open Trials is a great example of how the free, open source OSF infrastructure can be utilized by the community in different ways to increase transparency in scientific research,” Andrew Sallans, Center for Open Science Partnerships Lead, explained.
Open Trials will help to automatically identify which trial results have not been disclosed by matching registry data on trials that have been conducted against documents containing trial results. This will facilitate routine public audit of undisclosed results. It will also improve discoverability of other documents around clinical trials, which will be indexed and, in some cases, hosted. Lastly, it will help improve recruitment for clinical trials by making information and commentary on ongoing trials more accessible.
“This is an incredible opportunity to identify which trial results are being withheld,” Rufus Pollock, President and Founder of Open Knowledge, explained. “It is the perfect example of a project where opening up data and presenting it in a usable form will have a direct impact—it can literally save lives. We’re absolutely delighted to partner with Ben Goldacre, a leading expert and advocate in this space, as well as with the Center for Open Science and LJAF to conduct this groundbreaking work.”
The first phase of the Open Trials project is scheduled for completion in March 2017. For project updates, please follow @opentrials on twitter or get in touch with us at [email protected].
]]>