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.)

Research Highlights

• 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.

Approvals for Large Global Sponsor