EMEA and FDA Launching Clinical Trial Conduct Initiative

By: Jon Dellaquila, CIS Compliance Manager
jondellaquila@cis-partners.com

On August 3, 2009, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA) announced a collaborative initiative examining the conduct of clinical trials submitted in drug marketing applications. The pilot program, set to begin on September 1, 2009 and last for 18 months, will provide an opportunity for the two organizations to work together and allow for the sharing of information regarding good clinical practice (GCP) inspections conducted by the FDA and EMEA.[1] The intentions of the initiative will provide an open dialogue between the two organizations leading to a more efficient use of resources while improving the quality of clinical trials.

Facing a global economic recession, it is not surprising that some government agencies have begun assessing ideas to harmonize similar procedures. Currently, a large number of clinical trial participants come from the United States and the European Union - increasing the emphasis on why it may be important for these two organizations to work together. Since each agency operates with limited inspection resources, only a small sample of clinical trials can be inspected.[2] The scope of this program will allow for each organization to essentially double the number of inspections due to sharing of information or open the possibility of a joint inspection being performed. The key objectives of this initiative are:

To conduct periodic information exchanges on GCP-related information in order to streamline sharing of GCP inspection planning information, and to communicate timely and effectively on inspection outcomes.

To conduct collaborative GCP inspections by sharing information, experience, and inspection procedures, cooperating in the conduct of inspections, and sharing best-practice knowledge.
To share information on interpretation of GCP, by keeping each regulatory agency informed of GCP-related legislation, regulatory guidance and related documents, and act together to benefit the clinical research process.[1]

The collaborative effort will not only benefit inspectors from both agencies, but also the groups performing the clinical trials as well. The exchange of information will allow inspectors to become better informed with each organization’s inspection methods and styles; therefore, allowing the possibility to better educate the people responsible for performing the trials. At the end of the 18 months, the two agencies will evaluate the program’s success in achieving its goal of providing higher quality clinical trials.

This initiative could be the start of a more common practice among regulatory agencies. Although each agency has its own policies and procedures, they both remain rooted in the ideals of protecting patients and ensuring the highest quality of clinical trials. As the pharmaceutical industry develops new medicines, and additional developing countries begin participating in clinical trials, there is going to be an increasing need for quality inspection and oversight. A worldwide organization or panel governing clinical trial conduct may be closer than one would think.

Sources:
[1] United States. Food and Drug Administration. FDA, European Medicines Agency Launch Good Clinical Practices Initiative. 03 Aug 2009. Accessed on 19 Aug 2009.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm174983.htm
[2] European Union. European Medicines Agency. EMEA-FDA GCP Initiative. 31 Jul 2009. Accessed on 19 Aug 2009 http://www.emea.europa.eu/pdfs/general/direct/internationalcoop/EMEA_FDA_GCP_Initiative_2009.pdf