Resources:Â
Siow Bee Seu, Director of Clinical Operations for APAC at Indero, shares her insights in this episode, drawing on nearly 20 years of experience in clinical research across the APAC region. She brings expertise in project operations, regulatory strategy, and team management throughout diverse APAC markets. Â
The discussion focuses on three key areas:Â Â
- The Strategic Relevance of the APAC Region in Clinical Trials Â
- Adapting Clinical Trial Strategies to Country-Specific Contexts Â
- Managing Operational and Regulatory Nuances Across APACÂ
APACâs Role in Todayâs Clinical Trial Strategy Â
The APAC region is home to a large and diverse population, including India and China, 2 of the worldâs most populous countries, each projected to exceed 1.4 billion people in 2025. The region offers a mix of high- and low-cost countries, with several governments providing incentives that enhance cost-effectiveness in clinical trial execution.Â
Healthcare infrastructure, site capabilities, and experienced staff in countries such as Australia, Hong Kong, New Zealand, South Korea, and Singapore contribute to shorter startup timelines. In addition, countries like China, Malaysia, and South Korea have demonstrated strong recruitment performance, often enrolling the first patient or becoming top recruiters regionally and globally.Â
Government support and increased R&D investment continue to grow across APAC, helping reduce operational costs. There is also a noticeable shift from late phase to early phase capabilities, particularly in China and Malaysia, where investment in Phase I facilities is expanding. Countries such as China, India, and Japan remain key contributors to high-volume late phase trials, especially in oncology, cardiovascular, renal, and metabolic indications.Â
Innovation and biotech activity have increased significantly in China, Japan, and South Korea, with decentralized clinical trial (DCT) models and AI-driven trial design gaining traction over the past 5 years.Â
Selecting the Right Countries for Each Trial PhaseÂ
Early Phase TrialsÂ
Country selection for early phase trials depends on several factors, including startup and recruitment timelines, patient prevalence, trial design (e.g., first-in-human or healthy volunteer studies), and regulatory and marketing strategies.Â
Australia and New Zealand are preferred destinations for early phase trials due to their streamlined regulatory frameworks. In Australia, most trials can be submitted under the Clinical Trial Notification (CTN) scheme, which simplifies the process. For high-risk investigational products, such as class 4 biologics involving human or animal cells, the Clinical Trial Approval (CTA) scheme is used. Both countries offer well-established phase I units, often in private settings, which support rapid startup and high-quality execution.Â
South Korea presents a highly efficient environment for all phases. Early-phase trials in particular are supported by a streamlined regulatory process that allows for rapid IND and IRB approvals. The country has over 170 certified trial sites and is known for generating high-quality data aligned with global standards. A centralized healthcare system and strong public health literacy contribute to efficient patient recruitment and retention. Government investment further enhances its appeal.Â
China is increasingly active in early phase trials, particularly among local biotech and pharmaceutical companies. The country offers advantages in cost, recruitment speed, and alignment with local marketing strategies. Additional countries such as Japan, Singapore, Taiwan, and Malaysia are also expanding their early phase capabilities.Â
Late Phase TrialsÂ
Japan is a strategic location for late phase trials due to its large and aging population, which is ideal for studies in oncology, cardiovascular, and neurodegenerative diseases. The Pharmaceuticals and Medical Devices Agency (PMDA) offers regulatory flexibility through early consultation and accelerated pathways. Japan is recognized for its rigorous compliance and high data quality, making its trial results highly credible and often essential for global regulatory submissions, particularly in multi-regional clinical trials (MRCTs). Regulatory requirements often mandate the inclusion of Japanese patient populations, making Japan a key destination for global sponsors.Â
As we conclude another illuminating episode of Phase Forward, we find ourselves at the crossroads of science and progress. Remember that behind the jargon and statistics, lies stories of unwavering commitment, meticulous observation, and the pursuit of evidence that shapes our understanding of health and disease. Stay at the forefront of knowledge and innovation and follow Phase Forward on your preferred platform. My name is Valerie Coveney. Thank you for joining us. Until next time.Â
