Bridging Data Generation through Multinational Studies

다국가 임상시험을 이용한 가교자료 생성

Since the ICH E5 guidelines were adapt어 in ICH countries in 1998, the bridging data package became one of new drug approval requirements in Korea far the drugs developed in other countries. However the guideline does nat identify methods far bridging between two different populations. Korea is being involved in mare multinational clinical trials with New Chemical Entities that were developed in US and Europe. However there have been few attempts ta use the studies for bridging purposes and the Korean clinical data from the studies were seldom utilized in bridging far NDA due to the limited number of Korean patients that doesn't have sufficient statistical power far subgroup analyses. There are several literature that proposed statistical approaches and methodology to bridge global clinical data to a new population. This paper suggests possible options how to plan or utilize a multinational study to use the Korean subgroup data far bridging far New Drug Application in Korea.