Addressing the vast linguistic and cultural differences among different patient populations is among the biggest challenges sponsors outsourcing clinical trials must face.

Please look for our article in this month's issue of Applied Clinical Trials entitled "Language and Cultural Barriers in Global Trials". It discusses these challenges in how they affect the informed consent process, data accuracy, and the success of international clinical studies.

 

The European Union Clinical Trials Register was launched this past March by the European Medicines Agency. This new website allows first time public access to information on interventional clinical trials for medicines authorized in the twenty seven EU Member States as well as Iceland, Liechtenstein and Norway. The database also allows the public to search for information on authorized clinical trials being conducted outside the EU if these trials are part of a pediatric investigation plan (PIP).