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International Clinical Trials

Market Analysis: Asia-Pacific

China and India have been at the centre of discussions over the last 10 years, often being seen as the next big players in the pharmaceutical industry. However, the excitement over the potential of these countries has been dampened more recently, with companies facing claims of questionable ethics and fraudulent activities, and regulatory bodies presenting complex hurdles and lengthy timelines. During this time, less attention has been given to some of the other rapidly emerging markets in the Asia-Pacific region, such as Singapore, South Korea, Taiwan, Malaysia, Thailand, the Philippines, Indonesia and Vietnam.

Across all these countries, there is a growing middle class with a higher disposable income; an ageing population with longer life expectancy; urbanisation; a greater incidence of major diseases; and an increase in health consciousness. As such, the pharma market potential here is considerable, with growth in each country expected to be substantial over the next five years, particularly in Thailand, the Philippines and South Korea.

IMS Market Prognosis 2012 predicts the pharma market in Asia (excluding Japan) to reach $350 billion by 2016 – $80 billion of this from China, but the majority from these other less talked about markets. This accounts for 30% of the $1.2 trillion that makes up the global pharma market (1). Each country’s government has recognised the opportunity this industry can bring to national development, and are therefore focused on supporting and investing in the sector.

First and Second Tier

These emerging countries in Asia-Pacific can be divided into two tiers. The first is made up of Hong Kong, Singapore, South Korea and Taiwan, which have the most experience in clinical trials and are more developed in terms of infrastructure, regulatory set-up, medical care and technology. Sites in these countries work as part of a centralised healthcare system, with high-quality facilities and investigators.

The second tier includes Indonesia, Malaysia, the Philippines, Thailand and Vietnam. The clinical research environment for this group is less mature compared to the first-tier countries, but is steadily progressing – offering good-quality research at a significantly lower cost than the US and Europe.

Many investigators in these countries received their training overseas – largely in the US and Europe – and, with the sizeable increase in international clinical trials being conducted at local sites, personnel there are gaining experience fast. In addition, there are large pockets of people in the populations who cannot afford medical care; a trial gives them access to treatments and care they would otherwise be unable to pay for.

There are obvious advantages to working in Asia-Pacific; it presents cost efficiencies (country dependent, but about 30% less than Western nations); large treatment-naïve patient pools; high incidence in both developing and developed world diseases; and shorter start-up timelines. However, despite these – and the volume of trials there – many in the industry still have concerns about expanding clinical development activities into the region.

Perceived Risks

Questionable Data
With the shift to performing clinical research in emerging markets, Asia is gaining more experience working on global trials. This is providing site personnel with the opportunity to participate in training and have regular communication with study staff from countries that are much more advanced in clinical R&D. Furthermore, international presence in the region is growing, so the skill sets and knowledge of ICH Good Clinical Practice (GCP) are being transferred across territories.

This exposure, along with the increase of audits and inspections taking place, has underlined the international requirements that site personnel need to adhere to. Since the vast majority of studies implemented in Asia are international, many sites in both tiers have worked on trials where the results have been used for EMA and FDA submissions (2).

Quality is constantly improving right across the region, with the quality of data coming from trials in tier one countries comparable to that of Western standards. Singapore has led the way, followed by South Korea, which implemented Korean Good Clinical Practice legislation in 1995 and then revised this to be in line with ICH-GCP in 2001. The quality of trials in Taiwan has also been ranked among the best by worldwide institutions (3).

By 2012, the FDA had conducted 67 inspections in the majority of countries in the region – none of which issued an official action-indicated notification – with 29 of these presenting no objectionable conditions or practices at all. This signifies that data coming from sites in Asia-Pacific are meeting the acceptable global standards (4).

Under-Developed Infrastructure
The infrastructure varies greatly between countries and even within each nation itself. Singapore boasts one of the world’s best healthcare infrastructures (5). Meanwhile, in some second-tier countries, certain provinces can be more advanced than others and, when sophisticated equipment is called for, they borrow from the better equipped hospitals; overall advances in technology and equipment are visible, even if the building appears less developed.

The choice of site depends on the clinical study’s complexity, the logistics, standard of care and type of treatment, among other criteria. For a Phase 1 study where multiple pharmacokinetic sampling is required, or a complex oncology trial which relies on sophisticated diagnostics equipment, a first-tier country should generally be considered. Second-tier countries present advantages where a large patient pool and less advanced equipment is needed, for certain therapeutic areas such as infectious and tropical diseases, or when the protocol requires treatment-naïve patients.

Although Southeast Asian nations are at different stages of development, significant advances are being made and the large increase in GCP-certified sites have been established to support clinical research activities. Singapore, Malaysia and South Korea’s governments, for example, have been taking an active role in investing and building local research networks.

Complex Regulations
Governments in each of these countries have recognised that clinical trials bring additional revenue, better medical access and a higher standard of care. By working hard with the regulatory and ethical bodies to improve processes, they realise that this, in turn, will attract more studies. In addition, regulatory bodies in the region are making the move away from just maintaining their own benchmarks, and recognise they need to adopt international standards.

Across most countries, regulatory processes are becoming much more transparent and streamlined. However, there are some where the approval process is still lengthy. In the Philippines, for instance, it currently takes about six months to gain approval; but since the recruitment potential is so huge, in the long term, opening up a trial there will result in shorter overall study timelines and a decrease in total spend.

Establishing good relationships with regulatory authorities and engaging local personnel experienced in liaising with them are key to cutting down approval timelines. If a sponsor experiences longer timelines than projected, it is likely the responsible person does not truly know how to navigate the country’s system.

Investigator Motivation

Asia has a large pool of well-educated, highly motivated and enthusiastic investigators who have conducted their studies at reputed institutions in the US or Europe. In most of the countries, it is the institution that is paid the per-patient fee, although in the Philippines this is a part institution/part principal investigator payment. Still, the main motivation is to work as part of international clinical trials, growing their expertise and hopefully having their name in a publication, as this will help develop their career. Investigators are more conservative than in the West, so generally when they provide feasibility results there will be no great surprise with the recruitment rates.

Recruitment and Retention

According to a 2012 report from Tufts Center for the Study of Drug Development, clinical site activation rates in Asia-Pacific are at one of the highest, with 91% of sites successfully progressing through the study start-up stages and recruiting the first patients in at speed. Not only are site activation rates high, but investigative sites achieved target enrolment levels at 107% – making it the top region in that respect (6).

Despite these figures, with clinical research activities in this part of the world growing and the increase of complex protocols, it is necessary to emphasise the importance of patient recruitment. This is being recognised at site level – in Singapore, for example, some sites now have in-house recruitment teams to support this activity.

Within all Asian cultures, physicians are highly regarded and patients put their complete trust in their doctors, which works in favour of recruitment and maintaining low drop-out rates. In Asia, more of an emphasis is placed on the informed consent process, ensuring site staff are sufficiently trained in this area, and are educating trial subjects early on.

On top of this, extra efforts must be made to make sure participants feel involved for the trial duration. A 2013 report from the Center for Information and Study on Clinical Research Participation showed that in Asia-Pacific the prospect of receiving clinical results and regular updates about research during the study were the top factors for influencing their decision to take part. A further analysis indicated that a significantly higher percentage of trial participants in Asia-Pacific were receiving updates on either a daily basis or at least a few times a week, compared to the US and Europe (7).

Retention strategies are key to success in the region:
  • Assigning a dedicated study coordinator to each trial subject in order to create familiarity
  • Including personal touches, such as birthday cards in paediatric studies
  • Building in efficiencies – for example, combining a study visit with other regular visits the patient needs to make
  • Patient meetings, to create a sense of community and reinforce important messages
  • Weekly phone calls
The same report showed a considerably higher proportion of Asia-Pacific trial participants rating free procedures, free study drugs and their relationship with the staff as major motivators to stay in – 121%, 140% and 100% more than their European counterparts, respectively.

Culture and Geography
Many people underestimate the large number of diverse cultures, religions and languages making up Asia-Pacific, and companies should incorporate multiple country-specific strategies when preparing to work in the region.

Although Asian cultures are becoming westernised, there are still many elements of cultural sensitivity to be exercised. Numerous patient and physician motivations and rules of interactions must be understood around patient engagment. For site interaction, again there are different ways to communicate and negotiate to ensure motivation.

In addition, Asian countries can be prone to natural disasters, such as typhoons and earthquakes. Given the increasing governmental support for disaster planning, the risks from these events can be mitigated. Most sites are compliant in storing source documents in flood and fireproof areas, but this is an essential checkpoint for site selection.

Adoption of Western Trends

Risk-Based Monitoring
In first-tier countries where source documentation is available and there is a very high level of data quality, risk-based monitoring (RBM) is already being implemented. For the more developing countries in tier two, RBM would be difficult to adopt at this stage, mainly because source documentation is not always readily available. In Indonesia and the Philippines, it is possible that some patients may not even know their own date of birth. As sites take on experience in trials, at the same time receiving more training, RBM will be implemented – but it will still be a few years before this is the case.

Patient-Centricity
In the Asian marketplace, patients pay over 50% of healthcare expenditure out of their own pocket (8). Therefore, in order for companies to grow and be successful in this market, patient-centricity is key and needs to begin at the R&D stage, not just later on in a drug’s lifecycle. Patient-centric strategies are already widely adopted for clinical trials across Asia but, as in the West, they are still evolving and have not yet reached full potential. Technology is at the heart of this, and so it is in first-tier countries that these activities can currently be maximised.

Positive Outlook


Beyond China and India, the rest of Asia is also a very attractive draw for clinical trials. Like anywhere, setting up a study in Asia-Pacific comes with its challenges, but governments are investing hugely, monetaryand infrastructure-wise, as well as forging strategic relationships, to create a positive and efficient trial landscape.

With such a variety of nations in the region, each with such different characteristics, finding a country or countries which complement a protocol is easily achieved. High population densities in metropolitan areas, coupled with large hospital infrastructure, allow individual study sites to recruit greater numbers of patients more cost-effectively, while keeping timelines on target – and engaging the highly experienced local practitioners who know the intricacies of national systems and sites is key.

References
1. Asia Pacific Insight 3, IMS Health, 2013
2. Gupta SK, Drug Discovery and Clinical Research, 2011
3. Chan WK and Chen DS, Taiwan as a clinical trial center of excellence in the Asia Pacific, Asia Pacific Biotech, 2007
4. Sahoo U, Clinical Research in Asia: Opportunities and Challenges, 2012
5. The World Healthcare Report 2013, WHO, 2013
6. Getz K, Enrollment Performance: Weighing the "Facts", Applied Clinical Trials, 2012
7. Global study on public and patient perceptions of clinical research, Center for Information and Study on Clinical Research Participation, 2013
8. Asia Pacific Insight 4, IMS Health, 2014

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Dr Christophe Tournerie is the Founder and Chief Executive Officer of ClinActis Pte Ltd. He has more than 20 years of experience in clinical research in Europe and Asia-Pacific. After completing his medical studies in Paris, Christophe entered the pharma industry as Medical Director of a US biotech firm. He subsequently held senior posts at a global CRO before heading up the Asian clinical research activity for a multinational pharma company. In 2009, Christophe founded ClinActis, a full-service regional Asia-Pacific CRO, headquartered in Singapore.
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