Challenges and insights of early phase oncology drug development in the Asia-Pacific region

Herbert H. Loong, Daniel S. W. Tan, Toshio Shimizu


Early phase clinical trials form the very foundation of a drug’s clinical development. Traditionally, these trials were focused exclusively on dose optimization and toxicities with a broad aim across tumour types in the hope of achieving a signal of response. No real efforts were made to pair patients with best therapies. Moreover, early phase clinical trials have traditionally been performed in Western populations. Asia is the world’s largest continent in terms of population size, and is rich in ethnic, cultural and socio-economic diversities. There are also distinct regulatory and methods of healthcare provision between countries within the region. These qualities form a ‘double-edge sword’ when it comes to drug development. However, the rapidly growing population which inevitability leads to increasing patients’ numbers, coupled with improving economies and accessibility to quality healthcare put Asia in a prime position to play a more dominant role in early phase oncology drug development. At the same time, there is also increasing recognition of differences in disease epidemiology between different geographical regions, as well as potential pharmacogenomic differences between ethnicities. In this review article, the challenges faced, and opportunities foreseen for early phase oncology drug development in Asia will be discussed and illustrated with practical examples of international collaborations formed in recent years.