AOJS-3 - Practical issues and future perspectives on early phase development in Asia- competition, collaboration and harmonization

Abstract

In changing of landscape at drug development process, the nature of oncology early phase 1 drug development has changed substantially in recent years, with key changes in multiple areas of trial design, implementation and interpretation. Two of these trends-increased sample size and increased use of expansion cohorts. Changes in phase 1 trials have evolved as the knowledge of molecular biology accumulates and as molecularly targeted and immuno-oncology agents have become more important parts of the oncology therapeutic strategy. In addition to changing nature of recent early phase oncology new drug development, Asia needs to take the initiative in developing drugs to treat cancers prevalent in the region, especially in Asian specific cancers from the initial-early stage of development. The National Cancer Center (NCC) of Japan signed a memorandum of understanding with key oncology phase 1 centers in Asia including China (HKSAR : Hong Kong Special Administrative Region), Korea, Singapore and Taiwan, to form the Asian Oncology Early Phase 1 Consortium (AsiaOne), to drive the momentum towards international collaborative phase 1 clinical trials across Asia, and to realize efficient clinical development of early phase oncology drugs serving the region since September 2017. By promoting multinational collaborative clinical trials across Asia initiated by global pharmaceutical companies utilizing this platform efficiently, multinational investigator-initiated clinical trials coordinated by Asian investigators, collaboration with early-late phase drug development divisions of pharmaceuticals, and already established accelerated review pathways as well as progress and implementation of the ICH E17 guideline for planning and designing multiregional clinical trials including Asian countries, advancing suitable style of drug development including treatments for unmet needs in Asia and genome-driven drug development need to be accelerated.