CLINICAL RESEARCH IN ASIA PACIFIC
WHY ASIA PACIFIC?
Asia Pacific, the Growth Force
Economic growth remains strong in Asia Pacific markets despite the current economic crisis. The Asia Pacific drug development market is expected to reach USD 62.46 billion by 2026 and is projected to expand at a CAGR of 6.54%. (Source: Research and Markets.com - 29 August 2019)
Good Clinical Infrastructure in the Region
There is continuous growth in the scientific base and capabilities in Asia, encouraged by local authorities, given the growing contribution of clinical research to the local economy. There are centralized healthcare institutions, well qualified, highly motivated investigators and excellent clinical trial facilities, which are comparable to the best in class globally. Trials are supported by clinical trial units and study coordinators.
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. Typically, doctor-patient relationship is strong in Asia, thus securing good patient retention by sites. There are still fewer competing trials compared to the West.
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.