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International Clinical Trials

SEA Power

 

Adopting a tailored approach to clinical trials that takes cultural nuances into account can pave the way to robust, well-executed studies in South-East Asia. According to Clinicaltrials.gov, approximately 53 per cent of clinical trials are performed in the US, 24 per cent in Europe, and 23 per cent in Asia, Latin America, Africa and Australia (1). So while the majority of trials are still conducted in the US and Europe, sponsors are reaching out to Asia and Latin America on a regular basis.

Globally, Asian countries are becoming more prominent in international multinational trials (IMNTs). In recent years, there has been a surge in the number of trials conducted in Korea, Japan, China and India as part of the recruitment strategy of many biopharmaceutical companies’ R&D pipelines. Not too far behind is South-East Asia (SEA) (see Figure 1) (2). With a total population of 545 million in 2011 (see Table 1), a combined GDP of 21 per cent of that of the US, and an average GDP growth of more than five per cent, SEA clearly has exceptional potential for future clinical development (3). Its pharmaceutical market growth in 2011 was 10 per cent higher than 2012, which also highlights the future market potential.

Clinical trial excellence can be defi ned as execution of the right trial in a timely manner to the right patients, in the right location, with the highest quality standards, and within the allocated trial budget (see Figure 2, page 12). As companies look to share risk and to control R&D costs, we are seeing an increase in the outsourcing of various aspects of clinical development to CROs, fuelling the growth of the CRO market – currently predicted to be 10.7 per cent per year (2). The sponsor and CRO partnership should be synergistic, with returns benefitting both. Companies hold expert knowledge of their new molecular entities (NMEs) and intellectual property (IP), and are eager to bring drugs rapidly to the global market, thus allowing patients to benefit from novel treatments and the marketer from patent protection. This can be achieved in partnership with CROs that have both specific therapeutic and operational expertise to support with execution, and external expert insight and experience into successful trial delivery – including completion, database management and reports – for the sponsor.

Government-Driven Progress

The Association of Southeast Asian Nations’ (ASEAN) science and technology cooperatives efforts are directed towards the attainment of “a technologically competitive ASEAN, competent in strategic and enabling technologies, with an adequate pool of technologically qualifi ed and trained manpower, and strong networks with scientifi c and technological institutions and centres of excellence” (4). From an operational perspective, the double-digit growth forecast for the region has resulted in an increasing demand for clinical research monitors and site coordinators across these territories. There is an adequate number of suitable academically qualifi ed candidates entering the industry from medical disciplines; however, to ensure quality in delivery, given the pace of global trials, the operations team need to achieve the fine balance between ensuring effective support and oversight of new starters in the industry, and adequate supervision and on-site coaching from experienced staff.

It is clear from the efforts of the governments of SEA states, such as Malaysia and Singapore, that the biomedical industry has been immediately identified as holding great potential for the future. These states are investing heavily in infrastructure and training opportunities to support the pipeline of candidates for clinical research monitoring. The Malaysian government supports the International Conference on Harmonisation (ICH), Good Clinical Practice (GCP) training and assessment for their physician-investigators, and the Singapore government is collaborating with the industry to provide better training and development for site coordinators in the future.

Since ASEAN was formed in 1967, there have been efforts to homogenise the approach across the ASEAN member nations; however there are still variances in the clinical trial environment, to the extent that a varying level of local monitor input is essential to achieve successful outcomes at site level, either from a language perspective or from local knowledge of the landscape and key relationships. That said, there are geographical advantages within SEA, in that travel burden is generally less than that seen in other large single territories in Asia, and the diverse ethnic mix of populations in Singapore and Malaysia makes for a more flexible monitoring workforce with high levels of fl uency in English.

Globally speaking, the industry is moving towards a risk-based monitoring strategy, which is refining traditional monitoring activities based on specific considerations. These include specific requirements for the protocol and investigational product, aggregate statistical analysis of clinical data, and strategic assessments of site characteristics to identify risks, outliers, non-compliance and poor performance. Risk-based monitoring lends itself very well in a region with a mix of both mature and new study sites, providing greater flexibility with accessible sites that allow for half day monitoring visits. Risk-based monitoring permits a more remote review of data in line with advancing data collection technology. To take further advantage of this efficiency, a strong IT infrastructure is required both at the site level and for the monitors.

Tailored Approaches

In terms of network readiness, Singapore is the most networked nation in Asia and also the only Asian country ranked higher than the US (fi fth worldwide) (5). Malaysia is ranked first among the upper-middle income group of countries, while Indonesia has leapt 14 places in the ranking this year when assessed across IT readiness, usage and community support from institutions.

To be successful in SEA, we need to understand and embrace the cultural nuances of the various countries in SEA. One size does not fi t all. SEA possesses a unique set of challenges, with different regulatory, institutional review boards (IRBs) or ethical committee (EC) frameworks in different countries. Most regulatory agencies have clear guidelines for clinical trial application approval with timeline commitments. They are now better organised in compliance with ICHGCP guidelines (3). Sequential reviews, requiring drug (or health) authority approval prior to EC/IRB approval, or in-parallel reviews, are different between countries. The difference is not large though, and one need only consider an average of two-to-four months as a timeline for approval for the conduct of the trial when considering SEA as a location (see Table 2, page 12).

An infrastructure to support enrolment of patients into clinical trials at GCP-certifi ed sites has been established within the last decade. The rapid evolution of country capabilities, has resulted in an increasing number of sites that can perform trials – both domestic investigator-initiated trials and IMNTs with SEA participation – for example in Singapore and Malaysia. Full commitment and investment from their governments in establishing local clinical research networks has taken place in the last decade. Regionally, this is enhanced by niche therapeutic expertise, for example well-published clinician scientists with dedicated time to conduct research away from their clinical commitments. This environment has actively encouraged clinical teams to embark on research with industry-funded sponsors.

Key therapeutic areas in which SEA would be considered a ‘region-of-choice’ include infectious diseases, such as chronic hepatitis B or C virus (HBV or HCV) infection or HIV; several oncological indications, such as hepatocellular carcinoma (HCC); and neurological conditions such as epilepsy, and cardio-metabolic diseases (such as type 2 diabetes). The globalisation and urbanisation of Asian communities toward a more western-influenced diet and lifestyle has increased the number of treatmentnaïve diabetics and obese individuals available for new drug trials. The delay in the global vaccination programme for HBV in Thailand and Vietnam in the last two decades has created chronic HBV patient ‘cohorts’, and thereafter HCC as a disease progression of chronic HBV infection in the older group for oncology trials.

 

SEA is characterised by ethnic and cultural diversity in its populations. The potential investigators and key opinion leaders (KOLs) for trials are better engaged at different levels and with face-to-face communication, rather than being called upon remotely. Therefore, one needs to invest time and effort to garner the approval of thought leaders early on in the process. There are many KOLs in SEA who have trained in key Centres of Excellence (CoEs) in the US, Europe and Asia. These KOLs need to be identifi ed early on in academic, research-based institutions. Their invaluable input into study design, feasibility and their patients’ eligibility will allow R&D teams to save time in avoiding sites that will potentially pose enrolment challenges.

Protection of IP also needs to be considered. SEA countries, especially Singapore, have secure IP protection laws and safeguards in place that attract many companies. Other countries are following suit in order to attract multinational corporations to work with them. It is also important to understand and manage the complexities around healthcare access in these populations. Although a country may project large numbers for specific diseases in populations that are often treatment-naïve, access to in-country healthcare differs between rural and urban groups. Overcoming similar issues in this developing region over the next few years will pave the way for the future – robust, time-sensitive and well-executed trials in SEA.

Globalisation

This is one of the key paradigms to ensure a sponsoroutsourced partnership and execution of clinical trial excellence. To do this the sponsor or CRO needs to tailor a consistent global, but locally aligned, strategy in their partnership, and move away from the fee-for-service-only model (see Figure 3). The advantages of local language engagements with KOLs, existing familiar relationships between staff and health agencies, research centres and business regulations, and cultural awareness are advantages of having local support and specific strategy. Global strategy brings with it therapeutic expertise, project management and multi-regional experience in the conduct of trials that can support local execution, KOLs and staff and drive operational efficiency. Combining a global and local outlook in one strategy leads to better control and execution.

SEA may also prove be an important region for biosimilars development. With the FDA and EMA guidance for biosimilars carving out future requirements, companies in this area will soon need to act strategically when choosing appropriate countries, using investigators who will be keen to conduct these trials. At the same time, in SEA especially, payers and governments are looking for lower-cost medicines and welcome trials wherever access is limited, such as the case of expensive biologics, which may not be easily available to the local population in SEA. The need for quick turnaround times, even more rapid enrolment, and investigators who are passionate about treating their patients in bio-equivalence trials, are the prime reasons why SEA should be considered.

 

Conclusion

The ‘cost’ variable to the equation is not the only factor in deciding on the best model of service for outsourcing providers and sponsors; though important nonetheless, the value proposition of a long-term ‘win-win’ partnership between the sponsor and CRO in all phases of development is paramount in the next decade of clinical trial excellence in SEA and the rest of the world – tailoring strategies considering SEA early in the development process, addressing the needs of productivity and efficiency, and balancing the capacity and capabilities in the region.

References

  1. Brooks K, CRO industry update leveraging expertise for innovation, Contract Pharma, May 2011
  2. Sahoo A, The CRO market outlook to 2016, Business Insights, 2011
  3. Wong E, Clinical trials in SEA: an update, Drug Information Journal 43: pp57-91, 2009
  4. ASEAN: Vision for 2020: ASEAN Plan of Action on Science and Technology; 2007-2011
  5. Dutta S and Mia I, The World Economic Forum; Global Information Technology: Transformations 2.0 Report 2010-11: xix-xx

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Kenneth Lee is Senior Director of Scientifi c Affairs, Asia at PRA. Kenneth studied for his MD at the National University of Singapore (NUS) Faculty of Medicine, and obtained an MSc in Epidemiology from the London School of Hygiene and Tropical Medicine, University of London and is a cancer epidemiologist. His industry experience in oncology spans across clinical development and medical affairs, including numerous indications and the life cycle of products. Kenneth has provided scientific leadership to more than 20 advisory boards, investigator meetings and thought leader development activities. He was key regional medical lead for the largest global Phase 4 hepatocellular carcinoma trial, presented at ASCO 2011.

Helen Neal is Regional Director of Clinical Operations, Asia Pacific at PRA. Holding a higher degree in nursing and midwifery. Helen relocated to Singapore in 2007 to develop a management structure for clinical trial managers across Asia before taking on a leadership role accountable for the delivery of a set of clinical research programs across Asia (including India, China and Japan). Prior to joining PRA, Helen held a Senior Director role at another large global CRO in Singapore overseeing study management and delivery of clinical operations in South-East Asia, Australia and New Zealand.

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