Modern technologies and harmonization of clinical trial regulations facilitate globalization of clinical trials, and a recent analyses of studies registered in the WHO clinical trials registry indicates a shift of clinical trials mainly being performed in the US and Europe towards Asia.
Motivation for globalization can be diverse but typically concern considerations on budget and subject recruitment. Such a clinical strategy, however, falls or stands with mutual acceptance of clinical data thereby avoiding redundant duplication for ethical as well as resource reasons. Whereas FDA and Japanese guidances support use of foreign safety and effectiveness data, they at the same acknowledge the challenges that come with ethnic factors and differences in standard medical care.
Analyses on the origin of safety and effectiveness data supporting the FDA device/ PMA approvals over the last 15 years, indicate a slight downward trend using US data only in favor of combined US-OUS data. The majority of clinical data, however, still is US only, i.e. more than 60%. Personal experience indicates that the EU regulatory bodies tend to be more lenient towards use of foreign clinical data for approvals. However, when it subsequently comes to local implementation in health care practices, e.g. NICE guidances, typically also local clinical data are requested as they better reflect effectiveness within the concerning health care system.
In conclusion, whereas the circumstances allow for globalization of clinical trials, and the desirability of mutual acceptance of clinical data has been acknowledged within the ICH region, other factors still seem to outweigh possible benefits.
Annet Muetstege, Director Clinical Affairs, Applied Clinical Services BV