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Ethnobridging

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.

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

Ethnobridging Clinical Trial Volunteer database

Approvals for Large Global Sponsor

Ethnobridging PMDA Approval Status

Broad Ethnobridging Experience

Ethnobrdiging Experience List

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.

WCCT-Ethnobridging-Clinical-Trial-Case-Study
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