market analysis of clinical research in asia pacific

ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - [email protected]

Market Analysis of Clinical Research in

Asia-Pacific

ClinActis is exclusively focused on Asia Pacific, with solid expertise in applying international quality standards to regional specificities. ClinActis is flexible in our approach to work scope and budgeting and contracting process. Delivering Quality to Our Clients ClinActis is committed to implementing international standards in clinical trials. Our ability to deliver high quality results to our clients is based on recruiting and maintaining the best talent within our organization. ClinActis’ senior management is fully accountable for the quality of deliverables to our clients.


Your Proactive Clinical Research Partner in Asia Pacific

ClinActis Pte Ltd is a full service CRO providing clinical trial services to the pharmaceutical, medical device, medical nutrition and biotech companies in Asia Pacific. Established in 2009, ClinActis Pte Ltd is headquartered in Singapore. ClinActis Value Proposition ClinActis is a multicultural company. As such, the team is able to communicate effectively with international clients.


Mission and Vision With headquarters based in Asia, all corporate

decisions are made within the region, in order to better anticipate our client needs and adapt to local specificities. Vision Our vision is to become the reference CRO specialized in conducting clinical research in Asia Pacific, offering state of the art quality services, with cost effective solutions. We strive to employ people with genuine expertise in the region and with a passion for excellence, to work with our clients in the most pro-active way, and to build a relationship based on trust, transparency and strong ethics. Mission

Our mission is to provide our clients with unique and dynamic expertise in applying global drug development standards to the specificities of each country in the Asia Pacific region.


Operational Expertise – Regional Footprint

ClinActis Experience §  33 years experience in clinical

research in pharmaceutical and biotechnology companies as well as CROs

§  27 years experience in Asia Pacific, including Australia/New Zealand, China, Malaysia, Hong Kong, India, Indonesia, the Philippines, Singapore, South Korea, Taiwan, Thailand, Japan and Vietnam

§  Extensive knowledge of regulatory frameworks, best KOLs and sites across the region

§  Vast therapeutic experience including Oncology, Infectious diseases, CNS, Cardiovascular, Endocrinology, and Respiratory

Christophe Tournerie, MD – Owner and CEO Dr. Tournerie has more than 20 years experience in clinical research in Europe and Asia Pacific including Japan, working with biotechnology companies, pharmaceutical companies and clinical research organizations. After completion of his medical studies in Paris and various hospital assignments in France, Dr. Tournerie spent a period of 3 years at the National Medical Research Institute in France in the field of drug development in anti-HIV products.


About Our Founder

His introduction to the pharmaceutical industry was as Medical Director in an American biotechnology company developing anti-HIV products. Then, he moved to a large global CRO, heading the Project management Department for South Europe, and then as Head of Operations in the Japan affiliate. Later, Dr. Tournerie headed the Asian clinical research activity for a multi-national Pharmaceutical Company, based in Singapore. More recently, Dr. Tournerie was Vice President Asia Pacific for a large global CRO, based in Singapore. During this assignment, Dr. Tournerie developed the business strategy for the region, successfully established and directed operations in 12 countries and built a highly professional team.

Center of Discussion From Singapore to Korea, a host of lesser known markets are emerging from the shadow of larger, more dominant countries in Asia. With a sizeable increase in trials and national governments investing heavily in clinical R&D, major growth is predicted. China and India have been at the center 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.


Emerging Talent – Asia-Pacific Market Analysis

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; urbanization; 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.

Center of Discussion (continued) IMS Market Prognosis 2012 predicted 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 recognized 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 centralized 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.


Emerging Talent – Asia-Pacific Market Analysis First and Second Tier (continued) 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 (table 1).

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).

Perceived Risks (continued) 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.

Perceived Risks (continued) Complex Regulations: Governments in each of these countries have recognized 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 realize 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 recognize 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.

Perceived Risks (continued) 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.



Perceived Risks (continued) 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).



Perceived Risks (continued) Recruitment and Retention (continued): Despite these figures, with clinical research activities in this part of the world growing and the increase of complex protocols, it is necessary to emphasize the importance of patient recruitment. This is being recognized 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 favor 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).

Perceived Risks (continued) Recruitment and Retention (continued): Retention strategies are key to success in the region: q  Assigning a dedicated study coordinator to each trial subject in

order to create familiarity q  Including personal touches, such as birthday cards in pediatric

studies q  Building in efficiencies – for example, combining a study visit

with other regular visits the patient needs to make q  Patient meetings, to create a sense of community and reinforce

important messages q  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.


Emerging Talent – Asia-Pacific Market Analysis Perceived Risks (continued) 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 westernized, 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 engagement. 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.

Perceived Risks (continued) 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.




Emerging Talent – Asia-Pacific Market Analysis Perceived Risks (continued) 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 maximized.

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, monetary and 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


Contact Us for More Information

Imen Jelassi, PharmD, MSc EU Director, Strategic Relations M: +33 6 28 11 13 71 E: [email protected]

market analysis of clinical research in asia pacific

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