[From ethnic difference to ethnic similarity].

Area of Science:

• Pharmacogenomics
• Clinical Trial Management
• Drug Development

Background:

• Drug lag is a significant issue in medical supplies administration.
• High costs and slow speeds of clinical trials impede new drug applications in Japan.
• Simultaneous clinical development in East Asian countries (China, Korea, Taiwan) could overcome these challenges due to perceived ethnic similarities.

Purpose of the Study:

• To evaluate the feasibility of conducting simultaneous clinical trials with identical protocols across East Asian countries.
• To ensure drug safety and efficacy within each country through standardized dosage recommendations.
• To establish the scientific basis for mutual utilization of clinical trial data among China, Korea, and Japan.

Main Methods:

• Pharmacokinetics and pharmacodynamics examinations using clinical test data.
• Genetic similarity analysis using various anthropological techniques, including hereditary distance.
• Comparison of genetic diversity between East Asian populations and other regions (e.g., Western Europe).

Main Results:

• Pharmacokinetic and pharmacodynamic data are expected to demonstrate the potential for mutual utilization of clinical trial data.
• Genetic analyses are anticipated to provide evidence of ethnic similarity within East Asia.
• Establishing ethnic similarity is crucial for permitting multi-country clinical trials under the same protocol and dosage.

Conclusions:

• Simultaneous clinical development in East Asia offers a viable strategy to accelerate drug approval and reduce costs.
• Genetic and pharmacokinetic data are essential for validating the use of shared protocols in diverse populations.
• This approach can enhance global drug development by leveraging regional similarities while ensuring safety and efficacy.