Ethnobridging Clinical Research Capabilities
Ethnobridging in Phase I development demonstrates equivalence between Asian and non-Asian populations. Accomplished by comparing pharmacokinetics of the drug after administration to both ethnic groups, this strategy promotes a reduction in cost and development time, allowing sponsors to recruit patients in “global” safety and efficacy trials (Phase II-III) without repeating Phase I development in that region and population.
Developing New Therapies Globally
WCCT recruits from an ethnic population of over 15 million, and has a dedicated Asian recruitment and outreach department. With experience conducting over 185 ethnobridging studies since 2004, WCCT offers two potential solutions:
- A single study once the target doses for the global trial have been identified in the U.S.
- The addition of Asian subjects to the first-in-human (FIH) studies in the U.S.
(Both solutions have shown to decrease development time and increase asset value.)
- Conducted largest Ethnobridging study ever performed.
- Over 750 Asian volunteers recruited yearly.
- Largest patient capacity of all organizations conducting Ethnobridging studies.
Sample Experience List
Ethnobridging Case Studies
The following studies show results for 2 case studies, highlighting successful multi -ethnic patient enrollment and data approval by the PMDA.
Large Volume Caucasian, Japanese, and Han Chinese Case Study
The study consisted of multiple-dose pharmacokinetics and safety of the co-administration of **** and **** in healthy Han Chinese, Japanese, and Caucasian adult subjects.
- Study Population: Normal Healthy Volunteer, Japanese Bridging
- Target Enrollment: 135 subjects
- Enrollment: 45 Caucasian, 45 Japanese, 45 Han Chinese
The following schematic shows treatment assignments based on ethnicity, which were executed precisely.
Multi-Ethnic Case Study for Large Global Sponsor
At a single site, WCCT conducted one of the largest Ethnobridging studies to date, recruiting 26 subjects of each ethnicity in a rosuvastatin study, which included: Japanese, Caucasian, Asian Indian, Korean, Chinese, Filipino, and Vietnamese subjects. The study generated a range of data, and led to a label change stating that Asians, but not Asian Indians, needed to be administered a half-dose as opposed to Caucasians.