Conducting Clinical Trials In The Asia Pacific Region: Opportunities And Obstacles

By Ashish Jain

Global clinical trials are projected to exhibit a compound annual growth rate of 12.4 percent and reach revenues of $57 billion by 2020, according to a recent report by Frost & Sullivan. As the cost and complexity of drug development continue to increase, the Asia Pacific (APAC) region is a key destination for the conduct of clinical trials.

One of the primary advantages of conducting clinical trials in the Asia Pacific region — which includes East Asia, South Asia, Southeast Asia, and Oceania — is access to a large population of patients. In particular, sponsors of studies that require treatment-naïve patients may have greater success in the emerging economies of some APAC countries. As with the rest of the world, many of the countries in this region have aging populations in need of new pharmaceutical treatments and medical devices. Since government healthcare budgets in APAC countries tend to be lower than those in North America and Europe, clinical trials may represent a cost-effective way for patients to get access to innovative treatments.

Challenges of Conducting Studies in APAC Countries

Having different regulatory requirements and processes in different countries, sponsors who are considering the APAC region for their global clinical trials may be challenged with learning local regulations in each country and selecting local investigative sites that are familiar and capable of complying with ICH-GCP guidelines. Moreover, the standard of care may vary from country to country, which may impact recruitment rate and overall clinical trials timelines.

Sponsors should also keep in mind that the APAC region is ethnically, culturally, and linguistically diverse. Ethnic and cultural norms can influence perceptions of disease and attitudes towards clinical trial participation. In addition, this diversity can contribute to study complexity with the need to translate study materials and train site staff in multiple languages.

Considering the APAC Region for Your Clinical Trial

For sponsors who are considering conducting clinical trials in Asia Pacific countries, working with a partner with global experience, mindset, local staff, and offices and experience in the region should all be taken into account to ensure success.