Accelerating Drug Development: Global Clinical Trials and the role of Ethnic Bridging
The use of Ethnic Bridging to minimize the drug development lag due to ethnic factors has been long overdue. Traditionally, clinical trials were performed in different regions to address ethnic factors, but the difference in regulatory processes from country to country led to delays that not only caused a loss of profit, but caused public health issues around the globe.
Nowhere was this lag more evident than in Japan, where from 1999-2009 the delay of approval for Doxil, an important drug for Cancer treatment, shed light on the regulatory inconsistencies around the world. Approved in 75 countries after initial trials in 1999, it didn’t achieve approval status in Japan until 2009, a significant delay preventing countless eligible patients from receiving treatment.
Multiple factors contributed to the development lags in Japan, including suboptimal environments for clinical trials that amassed expenses at nearly four times the rate of trials in Europe or the US. Also, drug development sponsors submitting applications for regulatory review at the PMDA, Japan’s regulatory body (similar to the FDA), faced significant language barriers, systematic differences, and understaffing, making navigation increasingly difficult.
Finally, in 2007, the PMDA addressed the problem by encouraging Global Clinical Trials (GCT) with a focus on ethnic factors to reduce lag and streamline development. The implications for increased GCT are far-reaching, minimizing the duplication of data to enhance development processes worldwide.
With the trend toward GCT well underway, Ethnic Bridging has become a leading strategy for assessing product sensitivity to intrinsic ethnic factors. With access to a robust pool of Asian subjects and extensive experience conducting Ethnic Bridging trials, WCCT presents drug developers with the opportunity to utilize GCT to decrease development time, and lower costs to increase the overall valuation of their asset.