Ethnobridging studies

Thinking ahead to your global target markets

Increasingly companies are collecting data in Japanese and Chinese populations early in development to help fast-track drug registration in these important markets and reach patients sooner. With the right approach, global companies can generate a percentage of clinical data from ethnic populations living outside their native Asian countries to accelerate global product development.

Ethnobridging studies -- and volunteers who participate in them -- must meet strict “bridging” criteria to be accepted by regulatory authorities in China and Japan. Volunteers must be natives of these countries and have lived in China/Japan in recent years. Their lifestyles, especially with diet and other health-related factors, must not have changed significantly since relocating. Typically, these requirements mean that volunteers must live in areas with large Chinese or Japanese communities, such as Los Angeles or London, where they are more likely to maintain their native lifestyles.

Parexel was an early pioneer of this approach in close collaborations with Japan’s PMDA and continues to be a leader in ethnobridging trials, also known as ethnic sensitivity studies. Today, we can help our customers save even more time and resources with mixed population studies. These studies integrate a cohort of Japanese or Chinese volunteers into the SAD/MAD early phase trials to eliminate the need for a separate ethnobridging study, increasing value and speeding global development to help global companies reach patients in China and Japan earlier.

At Parexel, we collect data on Asian and non-Asian subjects at the same time, affording you greater opportunity to fast track clinical development because more is known about the compound sooner. This allows for better planning of Phase II and Phase III trials, globally. And with more than a decade of experience in Ethnobridging studies, we can offer:

  • Unmatched expertise in the diverse regulatory guidelines of China and Japan
  • In-depth understanding of the specifics needed to submit a complete clinical data package that is acceptable to regulatory agencies in the region
  • Access to large concentrations of Chinese and Japanese populations outside of their countries

We are always available for a conversation.

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We are always available for a conversation.

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