EU’s Breakthrough in Clinical Trial Transparency
In a 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 are already opening up their data to scrutiny. In the US, NIH’s clinicaltrials.gov hosts a similar database for voluntary submission of public and private clinical trial results. By January 1, 2015, however, all companies in the EU will be required by law to submit trial data for newly approved drugs. FDA is considering adopting such a policy, with safety and efficacy data-mining projects in mind.
As the analysis from ScienceInsider notes:
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.
Traditional publication formats 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 science was always meant to be 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 open trial data have been lauded in the literature, with comparisons made to successes in the open-source community (Dunn 2012). In one example, data-sharing led to rapid analysis and determination of treatment for a deadly e coli outbreak in 2011. By broadly applying standard protocols to ease the access and use of clinical trial information, researchers contend we will see huge health care improvements. Results include learning what treatments are best in which circumstances, determining contraindications faster, and increasing adoption and innovation rates in 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.
A. G. Dunn, R. O. Day, K. D. Mandl, E. Coiera. Learning from Hackers: Open-Source Clinical Trials. Science Translational Medicine 4, 132cm5–132cm5 (2012). Link