Ethnic Bridging in Phase 1 Clinical Trials:

A Strategy for Enhancing Asset Value and Accelerating Global Drug Development

 

WCCT Global took part in a webinar and Mel Affrime, PharmD, President and Chief Scientific Officer of WCCT, presented:

Ethnic Bridging in Phase 1 Clinical Trials: A Strategy for Enhancing Asset Value and Accelerating Global Drug Development

View the Recording here:

Key Takeaways

  • Provides historical data and explanations of development lag due to ethnic factors
  • Provides charts that map the rise in global clinical development
  • Discusses how global clinical development and Ethnic Bridging can prevent unnecessary duplication of clinical trials, offering efficient and cost-effective drug development models that aim to prevent development lag
  • Offers strategies on how to include ethnic bridging in your early clinical development plans
  • Specific case studies where ethnic bridging has been used in early clinical development
The possibility that ethnic differences exist in different populations with regards to drug metabolism and distribution has been documented for many years. These observed differences may be manifest in alterations in safety, efficacy and/or labeled dosages, or in terms of adverse event profiles in patients residing in different geographic regions. This created the perceived necessity to fully and separately develop new medicines for each geographic market.

This development practice evolved into a trend such that drug development was initiated in the USA or Europe, and development in other geographic regions followed in such countries as Japan, South Korea and Taiwan. Development in Canada, Australia, New Zealand, South Africa and South America generally kept pace with development in the USA and Europe. Consequently, throughout the 1980s and early 1990s there was an acknowledged 7 to 10 year ‘drug approval lag’ in Japan, South Korea and Taiwan. Thus, these populations suffered delayed access to new therapies even though safety and efficacy had already been established in other regions of the world. Consequently, it was difficult to explain to the patients residing in these regions why they had to wait so many years beyond the rest of the world to get access to these medications. The urgent need to rationalize and harmonize regulations was understood by regulators worldwide, as well as the global pharmaceutical industry. As a result, ICH E5 – Ethnic Factors in the Acceptability of Foreign Clinical Data (5 Feb 1998) was published and the concept of global clinical development was widely and rapidly adopted.

In recent years, with the rise of global clinical development, Ethnic Bridging in Phase 1 Clinical Trials has become a leading strategy for assessing product sensitivity as it can allow developers to prevent the unnecessary duplication of clinical trials, minimize costs and solve the drug lag issue simultaneously.

Quicker development time means increased valuation of your asset due to the ability to achieve commercial milestones earlier. Watch the webinar recording to hear about specific case studies and strategies on how to include ethnic bridging in your early clinical development plans to hasten regulatory acceptance of data worldwide.

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This webinar presented Ethnic Bridging in Phase 1 Clinical Trials: A Strategy for Enhancing Assent Value and Global Drug Development