In the past, clinical trials were conducted in the developed world. However, higher costs and the financial crisis forced pharmaceutical countries to look at emerging markets, such as Asia, as new locations for studies. The region’s solid economic growth (despite the slowdown in China), lower costs per patient and cheaper CROs compared to North America and Western Europe, as well as the large pool of eligible patients who have not been heavily pre-treated with other therapies, a large aging population and a wide range of disease patterns make Asia very attractive for biopharmaceutical companies.
According to clinicaltrials.gov, the number of studies conducted in Asia is increasing in comparison to other regions. A report from Research and Markets found that emerging countries will likely account for 25% of the global clinical trial market for drug development by 2020, up from 16% today. This is mainly due to some sponsors saving up to 50% on clinical trial costs in Asia. Additionally, Asian pharmaceutical sales have more than doubled from US$97 billion in 2001 to US$214 billion in 2010, and it is expected to hit US$386 billion in 2016, according to the Economist Intelligence Unit in 2012.
Despite the economic, demographic and epidemiologic advantages offered by Asia, biopharmaceutical companies continue to experience challenges that do not allow them to use the region to its full potential.
Low quality data and complex regulations
Sponsors say that one of the main problems is that Asia lacks skilled researchers and scientists, as well as efficient trial management strategies. A medical affairs professional based in Asia said that it is a challenge to identify the right kind of trial sites. "Of course you can recruit the patients in countries like China or India, but getting good quality data is not that easy. This is because it is not a cultural given fact that doctors and hospitals have to do research as it is in the US or the UK," he said. Another pharma expert said that infrastructure for hospitals and other clinical facilities are still not adequate in the region. This is a limitation for new drug development and early stage studies, and explains why some Asian countries like India still only focus on generics.
Regulatory complexity and administrative bureaucracy are also important issues in the region. There is not a harmonised set of clinical trial regulations; they can change quite frequently or be quite unclear, which makes it hard for sponsors to have the updated information needed to conduct studies. For example, a clinical trials expert in the Asia-Pacific region considered compensations in India to be quite problematic. "There are no clear guidelines on how much compensation a patient could ask for. Depending on each case, the compensation could vary from US$10,000 to US$100,000, so companies have to be really, really careful," he explained.
Also, the time required for clinical trial approval can be extremely long. For example, in China it can take more than a year whereas in neighbouring countries it might take six months. Additionally, in Taiwan and Korea it takes a long time to apply for import and export permits. In Taiwan, contracts are also an issue for global pharmaceutical companies because hospitals demand that they are written in the local language. "For global companies that use English, this is a problem. It is time consuming and expensive to either translate the documents or to negotiate with the hospitals," explained a clinical operations expert based in Taiwan.
Even though more than half of the world’s population lives in Asia, the region still faces the challenge of patient recruitment as most people live in rural areas where hospitals are not involved in research. As such, the lack of strategies to recruit and retain patients is still a problem in the region, according to several sponsors.
A clinical operations leader at a German pharmaceutical company based in several Asian countries suggested friendlier regulations, approval in less time and more training for both professional working as sponsors and CROs as urgent measures to facilitate running clinical trials in the region. However, some sponsors remain hesitant as they mentioned that despite some improvement in recent years, the government and regulators in some countries are not doing enough to change the current situation. Also, the region is still not working as a whole to improve certain conditions and we only see individual companies lobbying for change, they say.
Singapore, Hong Kong, Taiwan and Korea remain as some of the more advanced places in the region to conduct studies, especially for phase II trials, as regulations are more clear and stable, the quality of data is high, approval time fast and enrolment goals are met.