The United States clinical trial landscape is changing due to longer lead times and high costs. Finding qualified and experienced investigators and key opinion leaders (KOLs) can add to the already lengthy trial duration. CROs and Sponsor companies must collaborate and plan early on a robust, country-by-county game plan for strategic, business, and market related reasons. The global strategy may include the US, Europe, Asia-Pacific (APAC), Africa, Latin America and other smaller, targeted countries depending on the indication and Sponsor goals, but early planning is critical to help get better therapies to market approval faster.
The recent trend we are seeing is US biotechnology and pharmaceutical companies requesting information and proposals for APAC countries along with sites across the US and Europe. Sponsors realize while they need to have US sites, they also want to consider countries where they can improve overall enrollment. Much of the growth and demand for the Asia-Pacific region, especially Japan, Korea, Taiwan, China, and Singapore, is directly related to challenges with recruiting and retaining patients locally with US and European biotechnology and pharmaceutical companies.
It is no surprise why the Asia-Pacific region has become a highly sought after area for conducting clinical trials and is forecasted to reach $11.9 billion by 2025 according to Business Market Insights. Much of the growth is due to the much more streamlined regulatory pathway, the lower cost of conducting studies than in more developed countries, and access to a larger patient population within high quality institutions acting as sites. Additionally, we are seeing significant growth in many therapeutic areas like oncology, neurology, and endocrinology/metabolic because the cost per patient is often much lower across Asia than in developed regions.
Another benefit is that Asia has the ICH and GCP trained personnel and necessary experience to conduct global trials. The quality is extremely good, with oversight and robust regulations that support and promote successful EMEA and FDA submissions.
How will you reach enrollment targets in your next clinical trial? Are Asian countries being considered? Many US-based companies are seeking new options, and Asia is well positioned to become a preferred destination for clinical trial growth due to the many factors below:
Japan
1. World’s 4th largest pharmaceutical market
2. Patient access
3. Quality sites
4. Quality data
5. Extensive therapeutic area experience
6. Regulatory & licensing support
China
1. Large treatment-naïve patient populations
2. Quality sites
3. Data collected is accepted at the US FDA (Food and Drug Administration) and EMA (European Medicines Agency) for regulatory submissions
4. Experienced KOLs
5. High international compliance to standards
6. Cost-effective
South Korea
1. A global top 10 country for the number of clinical trials conducted
2. Patient availability - Major university hospitals are generally larger than 1,000 beds and receive as many as 10,000 or more outpatients a day
3. Global study experienced investigators & staffs - Korean investigators regularly receive intensive GCP training in these major hospitals nationwide
4. Speed - 30 working days needed from MFDS-CTA application to approval and 3 weeks (on average), IRB Submission to approval
5. Diverse therapeutic areas
6. Cost effective
7. Quality
Taiwan
1. Dense populations
2. Universal healthcare system
3. Cost effective
4. Strong clinical trial growth market
5. Ability for fast study start-up
6. Diverse therapeutic areas
Singapore
1. Good quality
2. Diverse therapeutic area
3. High effectiveness
4. Experience in conduct phase 1 study
5. Cover regional area
Author:
Clareece West
Chief Commercial Officer - Linical