CLINICAL RESEARCH IN ASIA PACIFIC
WHY ASIA PACIFIC?
Asia Pacific, the Growth Force
According to a recent report by Research and Markets, economic growth in Asia Pacific markets continues to remain strong. The Asia Pacific drug development market is projected to expand at a compound annual growth rate (CAGR) of 6.54% and is expected to reach USD 62.46 billion by 2026. This growth presents significant opportunities for companies looking to conduct clinical research in the region. (Source: Research and Markets, "Asia-Pacific Drug Development Market - Growth, Trends, and Forecast (2019-2024)," 29 August 2019).
It's worth noting that this report was published in 2019, and since then, the COVID-19 pandemic has had a significant impact on the healthcare industry, including clinical research. However, despite the challenges posed by the pandemic, the Asia Pacific region has demonstrated resilience in its ability to conduct clinical trials and adapt to the changing environment. For example, a recent article by the Asian Scientist Magazine highlights how Singapore has emerged as a hub for COVID-19 clinical trials, thanks to its robust infrastructure and regulatory framework. (Source: Asian Scientist Magazine, "Singapore Emerges As Hub For COVID-19 Clinical Trials," 28 June 2021).
Good Clinical Infrastructure in the Region
There is continuous growth of the scientific base and capabilities in the region. Local authorities have been increasingly supportive of clinical research, recognizing its growing contribution to the local economy. In Asia, we have access to centralized healthcare institutions with highly qualified and motivated investigators, as well as excellent clinical trial facilities that are on par with the best in the world. Clinical trial units and study coordinators provide additional support to ensure the success of our trials. At ClinActis, we leverage these resources to deliver exceptional clinical research services to our clients.
Efficient regulatory and ethics committee processes
With the appropriate approach, the regulatory approval processes in most Asia is no more complex than in the US or Europe, with the exception of China where it is still relatively complex and require long timelines. The trend is among the regulatory authorities within the region is towards reduction of regulatory approval timelines. Regulatory agencies in several countries do provide clear instructions on their processes and requirements for documentation. Most agencies provide this information on their websites, which are updated regularly to include the latest requirements and policies. All regulatory agencies are well organized and welcome meetings with sponsors as necessary to facilitate the submission and review process. The majority of healthcare institutions have well organized Ethics Committees (EC) / Institutional Review Boards (IRBs), which follow ICH GCP and have now acquired significant experience.
ICH GCP as the only standard
Many countries adhere to ICH GCP in their processes for EC committee submission and regulatory approval. Since 1995, clinical trials in Asia have been predominantly for FDA/EMEA submissions.
Faster patient recruitment and good retention
Asia offers a large and diverse patient pool, with nearly 60% of the world population living in the region. US/EU treatment guidelines are followed in the treatment of disease. There is a large treatment naïve population, with diseases of both developed and developing world, which offers strong prospects for large and rapid patient recruitment. Doctor-patient relationships are typically strong in Asia, thus securing good patient retention by sites. And there are comparatively fewer competing trials than in other regions of the world.
Including investigator sites in Asia can help reduce the overall drug development timelines, with a higher number of patients in fewer sites enable faster patient recruitment. Salary and out of pockets costs are still favorable when compared to Western countries, even if they are increasing.
IP protection in Asia remains an issue when compared to Western standards. However, there has been significant progress in some key Asian countries to enforce IP protection and implement patent laws. Singapore has established a strong track record for IP protection while China and India have made significant progress in this area. IP protection still has a long way to go in Asia but legislation concerning intellectual property rights (IPR) continues to improve.
There are strict customs regulations within each country to comply with. Strategies to deal with the specificities of logistics in Asia include building local knowledge of regulations and import procedures related to clinical trials, as well as designing an adequate distribution approach, together with third parties.