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 a large ethnic population in Southern California and has a dedicated Asian recruitment and outreach department to liaise with our volunteers. With experience conducting over 190 ethnobridging studies since 2004, WCCT offers two potential solutions:
- A single study in the U.S. once the target doses for the global study have been identified
- The addition of Asian subjects to the first-in-human (FIH) studies being conducted in the U.S.
Both solutions have shown to decrease development time and increase asset value.
- Conducted largest Ethnobridging study ever performed which led to a label change stating that Asians needed to be administered a half-dose as opposed to Caucasians
- Average ~750 Asian volunteers recruited yearly
- Over 9,000 Asian Volunteers in database
- Bi/Tri-lingual recruiting, marketing, and clinical operations staff
Approvals for Large Global Sponsor
Broad Ethnobridging Experience
Ethnobridging Case Study
The following case study highlights successful multi-ethnic subject 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.