Thursday, May 30, 2013

Clinical trial guidelines could see a revamp in the EU

Over the past five years, the number of clinical trials conducted in the European Union fell by 25%.  To combat this, the new draft guidelines for clinical trials were endorsed by the Public Health Committee earlier this week.  With a goal to make clinical trials simpler and still protect the rights of the patients, newer and simpler guidelines ruled on.  The Union realizes that clinical trails are developed to save lives, and therefore incentives into doing more research is needed.  To separate the complex clinical process, low risk clinical trials may have different rules.

According to the European Parliament Webpage, Other suggestions for changes made in the draft guidelines include the call for more transparency by way of publishing summaries that would be accessible in a large database and the inclusion of ethics committees to ensure that all patients understand the informed consent papers.

Do you think that these will eventually change the way clinical trials are run in the European Union?  Will this influence other regulations across the world to change when it comes to conducting clinical trials?




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