Asia: Preferred Destination for Clinical Trials
The clinical trials process is complicated and time-consuming, requiring substantial investment. Biotechnology and pharmaceutical companies in the United States (US) and Europe face escalating clinical trial costs and challenges in both recruiting and retaining patients. Additionally, companies have to navigate through complex regulatory processes. To overcome, these challenges, US and European biotechnology and pharmaceutical companies outsource their clinical studies to contract research organizations (CROs). This white paper highlights research on why Asia is a key destination for clinical trials.
Availability of vast patient pools, high-quality infrastructure, comparable quality and lower costs appeal to US and European companies.
There are 3 key benefits in outsourcing clinical trials to Asia:
- Resources, Capabilities and Speed: Elements unique to Asia include large treatment-naive patient pools, numerous clinical trial centres with advanced equipment and technology, comparable incidence and prevalence of Western diseases. The region’s knowledgeable physicians and Key Opinion Leaders (KOLs) provide attractive environments for clinical trials and facilitate speedy trials; while low healthcare spend by many governments in Asia makes clinical trials an attractive way for patients to access innovative therapies in these countries.
- Worldwide Data Acceptability: Data from clinical trials in Asia is routinely accepted as part of US Food and Drug Administration (US FDA) and European Medicines Agency (EMA) regulatory submissions. KOLs from Asia are often members of international expert groups and citable academic output from Asia is growing rapidly. Data from inspections conducted in Asia by US FDA and EMA show low levels of adverse findings versus the US or European Union (EU), indicating high international compliance to standards.
- Cost-Effectiveness: Costs in Asia for procedures, diagnostic tests and visits are generally 30-40% lower than the US and European countries.
Key factors to consider when selecting a CRO:
- Capability: The CRO should have a capable in-house team with strong project management skills and a keen understanding of regulatory requirements. A client-centric and flexible approach to project delivery is another attribute to look for. The CRO should also offer scalability of IT systems and sophisticated quality systems.
- Experience: Expertise in specific therapeutic areas, study types and trial phases; proven track record of trials in the biotech sector and with multi-region trials; and a thorough understanding of regulatory audits.
- Network: CROs should have a local presence and networks, and strong relationships with the principal investigators, KOLs, and institutions. CROs should also be flexible in their approach to working with multiple regional specialist CROs.