Jeff Montgomery edited untitled.tex  over 9 years ago

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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 forthe  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 isalso  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 formatsthat 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  tothe  successes of in  the open-source community\cite{Dunn_2012}. community \cite{Dunn_2012}.  Injust  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 increasingthe 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}