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Ethnic Bridging Studies

Optimising drug development, reducing duplication, and improving global patient care

Ethnic bridging trials play a critical role in modern drug development by ensuring that new therapies are safe and effective across diverse populations. 

These studies are designed to identify and understand ethnic differences in drug response, helping to tailor treatments for specific populations while avoiding unnecessary duplication of global clinical trials.

A typical ethnic bridging strategy begins with pharmacokinetic (PK) studies to assess how a drug is absorbed, distributed, metabolised, and excreted across different ethnic groups. This is followed by targeted pharmacodynamic (PD) and safety evaluations in a small cohort from the target ethnic population. Population PK modeling and simulation are also used to predict and compare responses. If meaningful differences are found, dose adjustments can be made to ensure efficacy and safety for all patient groups.

Benefits of ethnic bridging:

  • Minimises the need for large, redundant trials across multiple regions
  • Accelerates access to new therapies in global markets
  • Reduces overall development timelines and costs
  • Enables more personalised treatment based on ethnic-specific responses

An integrated approach

ICON combines deep expertise in early phase clinical development with the specialised recruitment capabilities of ethnic bridging trial partners who have highly successful track records in the recruitment of Asian volunteers for clinical research. These partnerships strengthen ICON’s ability to recruit Japanese and Chinese participants at our clinical research units in the U.S. and Europe, expanding access to a more diverse and representative participant population.

Our ethnic bridging approach considers every aspect of the trial process—from study planning, documentation, and recruitment management to providing multilingual staff and culturally tailored materials. This focus on cultural sensitivity ensures a respectful, inclusive experience for participants throughout the study.  

Benefit from ICON's end-to-end ethnic bridging trials featuring:

Sites

Specialised clinical research units

ICON’s Salt Lake City (USA) and Groningen (Netherlands) clinics are fully equipped and qualified to host Japanese and Chinese study populations, with advanced infrastructure to support high quality early phase research.

Languages-Translation

Multilingual & culturally sensitive teams

Dedicated bilingual staff and culturally attuned practices create a welcoming and respectful environment for participants.

Completed

Standardised operating procedures

All studies follow harmonised SOPs to ensure consistent quality and regulatory compliance across sites.

Collaboration

Expert project management

Experienced clinical professionals manage each study efficiently from initiation to close-out, supported by dedicated early-phase project managers.

Accountability

Tailored recruitment strategies

End-to-end management of ethnically targeted recruitment ensures timely enrolment of the right participants.

Consulting

Comprehensive scientific & medical support

In-house expertise across protocol design, regulatory submissions, medical writing, data management, biostatistics, bioanalysis, and GMP pharmacy services.

With a proven track record ICON enables faster, smarter, and more inclusive clinical development—bringing effective therapies to diverse patient populations around the world.

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