The European Union (EU) recently published over 70 pages of legislation to conclude the long, exhaustive effort to remedy their old system of clinical trial regulations. Daniel Cressey’s article on nature.com highlights important takeaways from the legislation as well as the reactions of industry groups and researchers.
Some of the major improvements to the system include the requirement to publish both positive and negative results to promote transparency in research, the creation of a centralized approval system for trials that are run in more than one country, and reduced regulation for lower risk trials.
Following these changes, there is hope to increase the number of clinical trials in the EU, which has declined by 25% over the past four years. In addition, the European Commission expects to save researchers €800 million a year with the improved system.
Although there are still potential flaws to be addressed before final release in 2016, the majority of industry stakeholders see this new legislation as a monumental improvement to the old system and hope for positive results to follow.
To read the full article, click here.