Challenges of conducting clinical trials in Asia

ABSTRACT

Unlike North America and European Union (EU), Asian continent appears to be an ideal destination for conducting cost-effective clinical trials utilizing the pool of treatment naïve subjects. With a population approaching 4.5 billion, recruitment of subjects can be done without a fear of limited patient pool across Asia. The burden of infectious and chronic diseases is also higher in Asian countries. The emerging clinical trial markets particularly China, South Korea, and Taiwan offers genetic diversity in population group, thus promoting the quality and generalizability of clinical trial’s data. Nonetheless, several challenges also exist for the Western sponsors in majority of the Asian countries; regulatory, operational and infrastructural challenges are atthe forefront. Challenges under the heads regulatory, operational, infrastructural, language and cultural, ethics, and future challenges have been discussed. SWOT analysis of Asian clinical trial’s market exhibits enormous opportunities for study sponsorswith manageable threats.