Implementing Ethnic Bridging in Phase 1 Trials
Implementing Ethnic Bridging in Phase 1 clinical trials offers Sponsors an opportunity to cut time and costs and helps to accelerate drug development worldwide. In our previous post, Ethnic Factors and Bridging Requirements, we discussed the ICH E5 guidelines for bridging studies, and highlighted factors which would necessitate Ethnic Bridging. Once it’s been determined that Ethnic Bridging should be used, there are additional factors that determine the type of bridging study to be implemented.
Initially, PMDA consultation can be an excellent tool to ensure compliance and produce a binding agreement. Consultation is not free, and should be scheduled at least two months in advance, but does ensure that all stipulations of ICH E5 are met. Studies vary greatly depending on several key factors, including the type of medication, ethnicity of the region, medical practice, drug class, and clinical experience. Once these factors have been weighed, a bridging strategy can be prepared, and clinical research can begin.
Once the target doses for the global trial have been identified, one of two solutions will be implemented: A single, stand-alone Ethnic Bridging study will be performed; or Asian subjects will be added to the first-in-human (FIH) trial. These options promote flexibility for different regulatory strategies and allow us to tailor each bridging study to the Sponsor’s needs. In these ways, WCCT can effectively promote a reduction in cost and development time.
With an average of 750 Asian volunteers recruited on a yearly basis and the largest bed capacity of all organizations performing bridging studies, WCCT provides a seamless transition to the clinical trial once the parameters have been determined. Having performed 185+ Ethnic Bridging trials, including the largest bridging study ever conducted, WCCT brings a breadth of experience to ensure all study goals are met. For examples of previous studies, including the dosing schematic, patient populations, and approval results, WCCT has made multiple case studies available for review on our Ethnic Bridging page.