Event Date/Time: May 16, 2005
End Date/Time: May 17, 2005
An increasing proportion of clinical trials are currently being conducted outside of the United States – a movement that is causing a tremendous shift in the method through which trials are designed as well as conducted. As regulatory guidelines in various countries continue to develop and standards are set in place, it is important that pharmaceutical companies also shift and develop methods and policies of trial conduct that are also in line with these developments. Logistical and operational issues in conducting clinical trials in various countries will also need to be addressed, as during the trials, a constant supply of product is required. Various countries with differing regulations relating to the importation of therapies cause continual challenges that must be addressed and rectified prior to the commencement of the trial. Strategies for the recruitment of subjects for participation in the trial will also need to be addressed and practices developed, based upon not only regulatory guidelines, but also based on the number of subjects needing to be recruited as well as the methods through which they will be recruited – taking into consideration the various cultures. Addressing cultural issues in various countries where trials are being conducted is also a major issue in ensuring that the clinical trials are conducted as quickly and effectively as possible. Finally, it is important to note the ethical considerations that need to be taken into account relating to the conduct of global trials, especially as related to pricing controls and post-approval availability.