Clinical Research: Phase 1 - Phase 4

Conducting Clinical Trials in the Asia Pacific Region: Opportunities and Obstacles

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.[1] 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.

Potential Advantages of Conducting Studies in the APAC Region

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.

Another key advantage of considering the APAC region is high-quality data at relatively low cost as compared to U.S. and Europe. With the exception of Japan, the cost of conducting trials in APAC countries is often significantly less than in the U.S. and Western Europe. This cost difference is often a result of reduced costs for procedures, diagnostic tests, and visits in addition to a trend of faster patient recruitment and increased drive to join studies.

There are many Key Opinion Leaders and centers of excellence across multiple therapeutic areas in the APAC region: for example, the National Taiwan University and the Seoul National University Hospital with expertise in cardiovascular and oncology diseases and the Royal Children’s Hospital in Melbourne, Australia, ranked as one of the top children’s hospitals globally.[2]

Conducting trials in Australia comes with additional benefits including an efficient and pragmatic regulatory pathway, tax incentives for running trials within the country, and ability to conduct early phase trials prior to IND submission. Sponsors who intend to market their products globally should be aware that regulatory agencies in certain APAC countries, such as Japan, China and Korea, require clinical trial data obtained from their ethnic population. An unexpected potential benefit of conducting clinical trials in APAC countries is improved market adoption. Sponsors have seen that if investigators gain experience with an investigative compound through clinical trials, the drug’s likelihood of success in that regional market improves.[3]

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. Premier Research is already successfully conducting trials in Australia and New Zealand (including over 25 studies within the past 3 years) and has recently announced expansion of operations into China, India, Singapore, South Korea, and Taiwan. Get in touch with our team for more information on how Premier Research can assist with successfully running your studies in the APAC region.

[1] Frost & Sullivan. Asia: Preferred Destination for Clinical Trials. March 2017.

[2] Cybermetrics Lab. Ranking Web of World Hospitals – World.

[3] MedProve. Asia to become the ideal destination for clinical trials.