[open-science] OpenTrialsFDA presents prototype as finalist for the Open Science Prize

Lieke Ploeger lieke.ploeger at okfn.org
Thu Dec 1 15:04:50 UTC 2016

OpenTrialsFDA presents prototype as finalist for the Open Science Prize

For immediate release

Open Knowledge International <https://okfn.org/> is thrilled to announce
that the OpenTrialsFDA team is presenting its prototype today at the BD2K
Open Data Science Symposium <http://event.capconcorp.com/wp/bd2k-odss/> in
Washington, DC as finalist for the Open Science Prize
<https://www.openscienceprize.org/>. 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 <http://event.capconcorp.com/wp/osp/> 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
<http://opentrials.net/> at Open Knowledge International.

OpenTrialsFDA works on making clinical trial data from the FDA (the US Food
and Drug Administration <http://www.fda.gov/>) 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 at FDA <http://www.accessdata.fda.gov/scripts/cder/daf/>.
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
https://fda.opentrials.net <https://fda.opentrials.net/search>.

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 <http://opentrials.net/about/>, 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

Dr Ben Goldacre said: “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 https://fda.opentrials.net/about and from the team’s video
at https://www.youtube.com/watch?v=BOWJL9Px9uA.

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 <https://twitter.com/bengoldacre> on twitter. Read more here
<https://www.phc.ox.ac.uk/team/ben-goldacre>. 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
<http://www.alltrials.net/> 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 Drugs at FDA website as a valuable
but underutilized source of unbiased clinical trial data. Dissatisfied with
the continuing underutilization of Drugs at FDA, he published a paper
<http://www.bmj.com/content/347/bmj.f5992>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.

Open Science Prize https://www.openscienceprize.org/res/p/finalists/
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.  The Open Data
Science Symposium will feature discussions with the leaders in big data,
open science, and biomedical research while also showcasing the finalists
of the Open Data Science Prize, a worldwide competition to harness the
innovative power of open data.

Lieke Ploeger

Communications Officer  | skype: laploeger  |  @liekeploeger

Open Knowledge  - See how data can change the world
http://okfn.org/  |  @okfn <http://twitter.com/OKFN>  |  OKF on Facebook
<https://www.facebook.com/OKFNetwork>  |  Blog <http://blog.okfn.org/>
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