Asian countries can offer great value as locations for clinical study sites. This is the fifth of a five-part series on getting the best out of your Southeast Asia clinical trial strategy. In parts IIa and IIb, we focused on South Korea, Taiwan, Singapore and Hong-Kong – the so-called “Tier 2” Asian countries. Part IIIa addressed the two Asian giants in the Tier-3 Asian countries: India and China. Finally, in Part IIIb, the current and last piece in this series, we’ll round off with the up and comers in Tier-3: Malaysia and Thailand.
In the introductory article of this series, we alluded to the opportunity for a few Tier-3 Asian countries to compete with the Tier-2 countries for global clinical trials. Part IIIa outlined the contrasting scenarios in India and China, with China certainly on an upward trajectory. Less well-known, but perhaps more promising are two smaller countries in this region, Malaysia and Thailand. Based on the number of multicenter clinical trials per one million population, derived from clinicaltrials.gov data, these two countries are certainly further ahead compared to China (Malaysia, 11.1; Thailand, 7.4; China, 1.4). In other words, to the extent that these are historical data reflecting current reality, the market already appears to have caught on to the benefits of running clinical trials in these countries. The underlying causes are not hard to see, and are consistent with what has been emphasized throughout this series – strong government commitment to support and develop internationally accepted GCP norms in the form of regulations, training and infrastructure.
So, let’s look at some of the government-driven initiatives promoting clinical trials, aimed at making these two countries more competitive with their Tier-2 Asian country counterparts, South Korea, Taiwan, Singapore and Hong Kong.
Malaysia has a population of 31 million with an adult literacy rate of 93 percent, and over 1,000 GCP-certified medical professionals. ICH-GCP was adopted in 2000. The Clinical Research Centre (CRC), established in August 2000, is the nodal organization within the Malaysian Ministry of Health charged with the responsibility of facilitating clinical research in the country. Its main focus is to develop capacity to conduct clinical research, and build a network of sites that currently comprises 33 hospitals providing access to 550 clinical investigators and 17 million patients. The CRC network serves as “single-window” resource to support the entire gamut of operations necessary to conduct a successful clinical trial including feasibility assessment, recruitment, site management, contracts, pricing, marketing and collaborations. In order to develop research capacity, CRC has devoted resources towards advanced training for over 25,000 doctors, scientists and clinical investigators. The CRC has also set up databases, including patient registries and healthcare surveys, promoting the contract research industry, and supporting investigator initiated research.
In 2010, the Malaysian government set up National Key Economic Areas (NKEAs) in pursuit of the ambitious goal of making Malaysia a “developed” country by year 2020. In June 2012, the Healthcare NKEAset up Clinical Research Malaysia (CRM), a non-profit company wholly owned by the Malaysian Ministry of Health. CRM’s goal is to make Malaysia the preferred destination for industry-sponsored research, with a target of 1000 clinical trials by 2020 along with the enabling goal of training 1000 clinicians to become principal investigators.This is a tall order considering that in 2015 this number stood at 201 trials. Nevertheless, the Malaysian government’s commitment and seriousness to achieve this goal bodes well for the global biopharma industry.
Thailand has been on the world clinical trials map since 1998 as the location for two key HIV/AIDS Vaccine trials (VAX003 and RV144), which were both conducted under the co-sponsorship of the Ministry of Public Health in collaboration with VaxGen, a US company (VAX003) or with the US government (RV144). These trials were clearly in response to a major public health crisis in Thailand. The Thai Prime Minister took a personal interest in ensuring that the trials were run efficiently, and the government received high marks from their US collaborators. This is probably one of the main reasons why Thailand has managed to attract significant interest as a location for globally sponsored clinical trials. It also served as the jumping off point to apply therich experience and learnings from the HIV/AIDS clinical trials effort. The country implemented GCP in 2000 and is endowed with modern medical facilities (over 1,000 public and 300 private hospitals for a population of 67 million). Thailand also has an adult literacy rate of 97 percent as well as a strong cadre of qualified and well trained medical professionals from US or Europe.
In addition to governmental support, there is significant “grass-roots” activism from scientists and clinicians to promote clinical research in Thailand. Two organizations, in particular bear special mention – Thailand towards Excellence in Clinical Trials (ThaiTECT) and Thailand Center of Excellence for Life Sciences (TCELS).
Finally, a word about our theme of pursuing an “Asia first” clinical development strategy for Western-based biopharma start-ups. Neither Malaysia nor Thailand would be appropriate – their small pharmaceutical market size ($1-3 Billion) is just not attractive to justify or sustain this strategy. Also, the infrastructure to conduct pre-clinical studies to support early-stage clinical trials is not yet sufficiently well-developed.
But, when it comes to late-stage clinical trials, both Malaysia and Thailand are poised to take the great leap forward to join the Tier-2 countries South Korea, Taiwan, Singapore and Hong Kong.
In this series of five articles we set out to examine the Asia opportunity for conducting clinical trials, particularlyfor start-up biopharma companies. Unlike established pharma companies, start-ups are under tremendous pressure to achieve clinical development milestones with limited budgets and aggressive timelines. This could be accomplished by implementing an “Asia-first” clinical development strategy. We identified Tier-2 Asian countries South Korea and Taiwan as ideally suited for such an approach. Among the Tier-3 Asian countries, China, by its sheer size would be hard to ignore, and the Chinese government has recently introduced some reforms to streamline their regulatory processes. Lastly, Malaysia and Thailand, with strong governmental commitment, are definitely on an upward trajectory to move from Tier-3 into the Tier-2 space.
*Ramani A. Aiyer, PhD, MBA is the Principal at Shasta BioVentures, San Jose, California, USA. To post comments to the author, Ramani can be reached at: [email protected]