Ethnobridging Clinical Trials
We deliver solutions that decrease development time and add asset value.
WCCT is uniquely situated in Southern California, home to diverse Asian-American, Hispanic and African-American populations.
The goal of ethnobridging is to demonstrate that a drug behaves similarly in Asians and non-Asians. These trials are accomplished by comparing the pharmacokinetics of the drug after administration to subjects from both ethnic groups. This enables the sponsor to reduce costs by recruiting patients in its “global” safety and efficacy trials (Phase II-III) in Asia without repeating Phase I development in that region and population.
WCCT offers two potential solutions:
Adding Asian subjects to the first-in-human (FIH) study in the U.S.
Both solutions decrease development time and add asset value, but solution two saves more time and has the potential to increase asset value.
WCCT has conducted over 170 Asian/Ethnobridging/Japanese bridging/PK bridging trials since 2004, and is at the forefront of advancing global drug development. In one WCCT case study, a sponsor tested 120 volunteers with five key endpoints: SAD, MAD, food effect, ethnobridging comparison and monitoring of the primary pharmacodynamic endpoint (platelet aggregation). PK bridging Studies like these are a critical pathway for allowing development plans to include Japan and the rest of Asia in the global Phase III program.
At a single site, in one of the largest Asian bridging studies ever, WCCT recruited 26 Japanese, 26 Caucasian, 26 Asian Indian, 26 Korean, 26 Chinese, 26 Filipino and 26 Vietnamese volunteers for a rosuvastatin study. This study, along with other data generated, resulted in a label change for rosuvastatin stating that Asians, but not Asian Indians, needed to be given half the dose as compared to Caucasians.
Approvals for Large Global Sponsor
For sponsors interested in increasing the value of their NCE asset, WCCT can contract and draft a complete Phase I program development that incorporates ethnobridging strategies. Depending on your company goals, in terms of innovative PK bridging study design, it is not uncommon to add small sample of Korean or Chinese subjects to Japanese subjects to an ethnobridging trial.
Ethnobridging Video Series
Get introduced to ethnobridging, and its role in enhancing value and accelerating global drug development.