Clinical Trial Transparency – Where are We Heading?

Clinical Trials Data sharing is important.  It can strengthen academic research, the practice of medicine, and the integrity of the clinical trial system. Extent of clinical trial data transparency and public availability has been evolving since 2004. Recently the FDAAA 801 amendments in the US and the new EU Clinical Trials Regulation No 536/2014 replacing Directive 2001/20/EC include provisions that will impact pharmaceutical companies and the way they report and disclose clinical trials data. The presentation will brief the new rules and the resulting changes.