Phase 1 Ethnic Bridging Clinical Trials Q&A

 

Ethnic Bridging Clinical Trials are helping to streamline drug development worldwide, and WCCT is proud to be an integral part of this trend toward global development. With the increasing amount of interest garnered from our Ethnic Bridging content, we thought it was time to answer some key questions:

 

What are the qualifications of the participants of ethnic specific groups?

For studies requiring the participation of specific ethnic groups, the only necessary qualification is that they can prove ancestry on both sides of their family. From our past experiences, we have learned that genetic compliance is the only predetermined factor. Extrinsic factors, such as how long the individual has been living in the United States, do not change the genetic factors that are examined in Ethnic Bridging trials.

 

What is a typical cohort size for Ethnic Bridging?

The typical cohort size varies based on the needs of the specific study. WCCT has conducted studies with 135 total subjects (45 Han Chinese, 45 Japanese, and 45 Caucasian). We’ve also conducted many studies where fewer (8-12) were required. In general, cohort size ranges from trial to trial, and requires the CRO to understand the specific development and commercialization needs of the developer.

 

What is WCCT’s suggested model to accelerate drug development in Asia?

With the overall goal of eliminating the need for phase 1 clinical trials in the targeted region, we suggest Phase I development in a single region, such as the US. From there, we would initiate an Ethnic Bridging portion of the trial for the intended Asian region. Based on the exposure and results of the study, we would use the information to begin Phase II-III development in the targeted region.

To accelerate your trials even more, we would integrate the ethnic group into the First In Human study rather than having a separate study for Ethnic Bridging, so that you can determine safety, tolerance and PK/ PD across doses and ethnic groups.

 

When Asian countries approve a drug, is there a delay in approval from Western Countries?

In general, delays have traditionally taken place during approval in Asian countries, whereas countries in the EU and North America tend to reach faster conclusions. As of late, Taiwanese, Japanese, and Korean health authorities have been working together to streamline processes, sharing data and procedural information to ensure fewer delays. Globally, with the increase in Ethnic Bridging trials and formal cooperation and communication between Asian countries, development delays leading to health crises are becoming far less common.

 

For more detailed information on specific areas of Ethnic Bridging trials and Phase I drug development, check out the recent webinar conducted by Mel Affrime, PharmD, President and Chief Scientific Officer of WCCT. We’ve also explored these topics in-depth on our blog, which you can explore here.