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In a \href{http://news.sciencemag.org/europe/2014/10/e-u-medicines-agency-hands-victory-advocates-trial-data-sharing?utm_campaign=email-news-latest}{breakthrough victory} for open access, the EU's European Medicines Agency (EMA) approved a system last week that provides researchers and the public with the vast majority of data from clinical trials. While generally resistant to such developments, some pharmaceutical companies
have are already
opened opening up their data to scrutiny. In the US, NIH's \href{https://www.clinicaltrials.gov/ct2/home}{clinicaltrials.gov} hosts a similar database for
the voluntary submission of public and private clinical trial results. By January 1, 2015, however, all companies in the EU will be
required \textbf{required by
law law} to submit trial data for newly approved drugs. FDA is
also considering adopting such a policy, with
large scale drug safety and efficacy \href{http://www.alzforum.org/news/community-news/opening-doors-clinical-trial-data}{data-mining projects} in mind.
As the analysis from ScienceInsider notes:
\begin{quote}Published journal articles often contain the main outcomes, . . . but lack detailed data and information about study design, efficacy, and safety analysis, which might shed a different light on the results when analyzed by others; moreover, some trials aren't published at all. The AllTrials campaign has argued that the details of every trial should be publicly available for anyone to study. \end{quote}
Traditional publication formats
that are disconnected from modern needs? A move toward data-rich scientific content? Opening up the process of verification and analysis to a wider audience? It's as if \href{https://www.authorea.com/users/3/articles/6316/_show_article}{science was always meant to be
open},or open}, or something.
Naturally, there are caveats to the ruling. Only identified researchers can download searchable trial results and data, while registered
public users can only view results on-screen. Further, certain types of commercially relevant data may be redacted by companies, with the EMA providing an 18 month window before completed trial results are finalized and posted. Still, however, this represents a huge step forward for widespread access to and synthesis of information that could be critical for improving patient outcomes.
Long-sought by many researchers, the beneficial network effects of
opening up clinical open trial data have been lauded in the literature, with comparisons
made to
the successes
of in the open-source
community\cite{Dunn_2012}. community \cite{Dunn_2012}. In
just one example, data-sharing led to rapid analysis and determination of treatment for a deadly \textit{e coli} outbreak in 2011. By broadly applying standard protocols to
ease the
dissemination of information access and
data from use of clinical
trials, trial information, researchers
believe contend we will
practice better medicine by see huge health care improvements. Results include learning what treatments are best in which circumstances, determining contraindications faster, and increasing
the rate of adoption and innovation
rates in
treatment. treatments.
Here's to hoping EMA's actions are successful, FDA approves similar measures, and science in aggregate opens up to take advantage of these synergetic network effects.
\href{http://www.ema.europa.eu/docs/en_GB/document_library/Report/2014/10/WC500174378.pdf}{EMA Q&A release}