Supporting Global Drug Submissions with Ethnobridging
Altasciences can help accelerate your global drug development plan with ethnobridging in Phase I development. Ethnobridging demonstrates equivalence between Asian and non-Asian populations by comparing pharmacokinetics of the investigational drug after administration to both ethnic groups. A Phase I ethnobridging strategy allows you to recruit patients in “global” safety and efficacy trials (Phase II-III) without repeating Phase I development in that region and population.
Our approach to ethnobridging clinical trials begins in Phase I and is based on two key elements:
- Researching Japanese, Chinese, and Korean populations in clinical trials taking place outside of their home countries, where clinical development is initiated but the protocols comply with regulations of the native countries and the resulting clinical trial data are acceptable to native country regulators.
- Researching all required populations at once instead of waiting until non-Asian clinical trials are completed before starting bridging studies in Asian countries.
Ethnobridging studies can reduce drug development timelines by four or five extra years – the time it typically takes to complete clinical development in the region as compared with North America or Europe. With ethnobridging, timelines can be compressed significantly.
Ethnobridging Clinical Trial Expertise
We have conducted over 200 ethnobridging studies since 2004, and offer two potential solutions, both of which decrease development time and increase asset value. You may choose between:
- A single study in the U.S. once the target doses for the global study have been identified
- The addition of Asian study participants to the first-in-human (FIH) studies being conducted in the U.S.
Altasciences recruits from a large ethnic population, and has a dedicated, multilingual Asian recruitment and outreach department to liaise with our participants.
We conducted the 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.
- We recruit an average of ~750 Asian participants yearly
- We have over 9,000 Asian participants in our database
- We have multilingual recruiting, marketing, and clinical operations staff
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