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 200 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.

Ethnobridging Research Highlights

• 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.