Clinical Trial Data: the EU Requires Full Disclosure
On April 2nd the EU voted to change the way clinical trials are reported. No longer are drug companies going to be able to withhold results of any unfavourable trials, according to a report in the Wall Street Journal. Under the new law all clinical study reports and their results will need to be published within 12 months of the end of the trial. The vote will be taken on this new legislation on April 3 2014, and should it be passed, it will come into force in 2016.
Data sharing in general has been enhanced since 2000, when the National Institutes of Health launched the clinicaltrials.gov website. The purpose of the site was to provide information on clinical studies to the public. Initially, the site was dedicated to research funded by the NIH, but now it includes private and public funded research in order to enhance the sharing of the data collected from the clinical trials. The site has proven to be well used, with more than 95 million page views per month and 60,000 unique visitors per day, figures provided directly from the NIH themselves.
Transparency in Clinical Trials
The success of the clinicaltrials.gov website goes to show the eagerness for visibility when it comes to clinical trial research and data collection. Should the new legislation be passed under the EU law the level of transparency for the public will be increased, helping to provide them with facts and figures like never before. However, Dr Breckenridge, the Chair of the United Kingdom’s Department of Health Emerging Science and Bioethics Advisory Committee points out that just because there is an increase in transparency it doesn’t mean it will help to develop trust.
Trust can only be built upon providing honest and competent results. Therefore there is a risk that the increased availability will expose some of the inherent inefficiencies in the system. This is a good thing, as it will serve to improve the actions and make the most of what transparency in clinical trials offers. Dr Breckenridge has provided five keystones to work on moving forward:
- Agreeing on the release of information timing
- Agreeing on the nature of the information that will be released
- Protection of personalized data
- Creating the standards for the meta-analyses
- The rules of engagement for the observational studies
Now that the EU parliament vote has gone through there are some policy issues that need to be considered. These include whether the transparency should be a working collaboration between the private and public parties or if it will be a dictate of the government. It’s also important to consider the role the patients will play and if there will be a formalized transparency consortia and if it should be global. Other policy issues to consider are if the transparency can be used to provide a competitive advantage on top of the public health imperative. Finally, there is a need for discovering the implications for the intellectual property.