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International Clinical Trials

Into the East

Recent years have seen an observable shift in the outsourcing of clinical research, with industry-sponsored studies moving away from the traditional base of North America and Western Europe, to regions such as Eastern Europe, Latin America and, in particular, Asia. In fact, research estimates that by 2015, more than 50 per cent of growth in global clinical trials will be directly attributed to their offshoring to emerging markets.

Asia, being the largest and most populous continent with over four billion people, offers many opportunities as a destination for clinical research. Indeed, Southeast Asia is home to a rapidly expanding pharmaceutical market, with an environment and infrastructure for conducting trials that has improved significantly.

Regional Focus

International multi-centre clinical trials are often considered a faster alternative to national trials to get products onto the global market. Currently, more than 15,000 global trials are being carried out in the larger Asia-Pacific region.

With steadily increasing drug development costs and timelines, and the desire to access global patient populations, conducting clinical trials in Southeast Asia is an appealing option for many international pharma companies. Several companies and contract research organisations (CROs) have established and built their trial monitoring facilities in the region to perform clinical trials to international standards and meet regulatory requirements.

Early-Stage Research

Although the region has demonstrated its capability for performing Phase 2 and 3 trials, earlier Phase 1 trials are still under-represented. The conduct of Phase 1 first-in-human trials – primarily designed to evaluate the safety of new pharmaceutical agents – is typically considered to be more challenging than later-stage trials, with participating patients usually not expected to derive any direct therapeutic benefit.

Historically, companies have often judged that many developing countries, particularly in Southeast Asia, did not possess the range of skills and expertise necessary to conduct early-stage trials. For example, the large majority of early-stage HIV/AIDS trials are carried out in the US and Europe, even though over 90 per cent of people living with HIV are found in developing countries.

However, this situation is improving, with the region now seeing an increase in early-stage trials. Indeed, many commentators agree that it is essential to conduct earlystage clinical research in populations proportional to the potential use of medicines following approval, as race and genetics can be important determinants in the variability of response.

Trial Incentives

There are many benefits to conducting clinical trials in Southeast Asia. Recent trends in population dynamics and diseases, and their impact on healthcare, have been shaping the future of clinical trials in Asia, and particularly China. Due to changes in living standards and relative prosperity, many of the chronic diseases of the West, such as diabetes and hypertension, are now global diseases.

One of the major incentives for Asia-based trials is cost. As developing a single drug can cost more than $200 million and take at least 10 years, Asia (with the exception of Japan) offers a less expensive and often less timeconsuming process for clinical trials. Outsourcing in Asia can reduce the cost of trials by more than 50 per cent. For example, in China the average cost of Phase 1 and Phase 2/3 trials can be 15 and 20 per cent, respectively, of the cost incurred in Western countries.

Asia also possesses a large, genetically diverse population, with many patients never having received medication to treat their conditions. The large patient pool available for trials enables faster patient recruitment, which can contribute to shortening the development time for new drugs.

Less complicated regulatory regimes in the region can – although certainly not always – result in faster approval timelines. In addition, with close clinical trial monitoring and sound project management, many centres can perform highquality Good Clinical Practice (GCP) compliant trials that compete favourably, in terms of cost and patient recruitment, with those in Europe or North America.

Careful Planning

Despite the advantages, studies in Asia require careful planning to succeed. Accessing global patient populations in emerging markets requires a detailed assessment and comprehension of how to approach and manage differences in regulatory requirements, business practices, language and culture. In China, for instance, almost all regulatory submission documents are required in Chinese, which can impact on costs and timelines.

If not managed effectively, unforeseen cultural factors can also skew or interfere with both the reporting and interpretation of clinical data. Patient perception and reporting can be significantly affected by cultural attitudes. Again, to use China as an example, it has been observed that symptoms such as pain are often under-reported by Chinese patients, which has the potential to lead to misinterpretation of study data.

In some regions, patients may unknowingly continue to take traditional alternative medicines alongside the prescribed trial agent. Furthermore, because of cultural and religious reasons, countries such as Malaysia, the Philippines and Indonesia require specific information on sources of all ingredients of animal origin as part of the new drug registration process. As a result of these challenges, many international companies may choose to work with local CROs which are more familiar with local customs, culture and practices.

Intellectual Property

Another concern to international firms performing trials in the region is the often lax enforcement of intellectual property (IP) rights. For example, it may be diffi cult for an international company to ensure that the formula for its new drug candidate will be kept strictly confidential when working with a local CRO, even after all parties have entered into confidentiality agreements. Certain measures have been taken to improve the situation; with the World Trade Organization’s agreement on Trade Related Aspects of Intellectual Property Rights, member countries are required to establish minimum standards concerning the scope and use of IP rights and the system for enforcing them.

Regulatory Environment

The regulatory regimes in Southeast Asian countries share certain features in common but, in general, there are many differences in systems and registration processes. In particular, many regulatory agencies in the region have been constrained by a lack of resources. Agencies also tend to have more experience in handling applications relating to generic, rather than new, chemical entities. Historically, their procedures and processes lacked consistency and transparency, but this situation is improving due to increased dialogue with industry.

If companies do not have local manufacturing capabilities, the investigational product may need to be imported. However, national requirements to obtain import and export licences may delay trial initiation. In countries such as China, the improving regulatory environment and timelines continue to promote the growth of outsourced clinical trials. Furthermore, most Asian countries have now implemented the International Conference on Harmonisation’s GCP guidelines.

China Experience

Conducting multinational early-stage clinical trials in China is somewhat of a new phenomenon, and differences in some local regulations and practices can affect the way that trials are arranged and carried out. In recent years, the Chinese government has issued guidelines for Phase 1 clinical drug trials in an effort to improve safety and organisation, and make them less time-consuming.

Prior to performing clinical trials in China, companies are required to obtain approval from the China Food and Drug Administration (CFDA); only CFDA-approved sites are authorised to conduct trials. There are currently over 400 CFDA-accredited sites across the country.

The CFDA requires clinical institutions to establish a special administrative offi ce with full-time staff to provide oversight on clinical trials, and to strictly implement relevant laws and regulations to ensure compliance with GCP. An ethics committee should be established at trial sites to take responsibility for examining the experimental design and the procedures to be employed to protect patients. However, in practice, some sites in China have not set up a committee, or its composition may not meet GCP requirements.

Pharmaceutical agents used in Chinese clinical trials must be manufactured in facilities which comply with Good Manufacturing Practice, and must also be submitted for assay and evaluation to the National Institute of the Control of Pharmaceutical and Biological Products. Without an analysis certificate, the ethics committee will not approve the study.

Compared to the West, a larger proportion of hospitals and clinical centres in China are therapeutically focused; this can confer an advantage in terms of trial enrolment for specific clinical indications. Once up and running, the CFDA and the provincial food and drug administration have the right to inspect ongoing clinical trials and the power to modify the trial protocol, or suspend or even terminate the trial if GCP is not being followed.

Fuelling Growth

With steadily increasing drug development costs and significant time spent on clinical trials, the outsourcing of clinical trials to Southeast Asia holds much appeal for pharma companies, despite lingering concerns over the protection of IP rights. The governments of many countries in the region have identified the biomedical and life sciences industry as a key sector for continued economic growth and development.

The continuing globalisation of pharmaceutical development will create increasing opportunities for Southeast Asian trial sites and further fuel the growth of the clinical trial market in the region. Domestic companies, particularly in China, are also showing increasing interest in co-developing drug candidates with international partners.

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Nick Beckett is Managing Partner of CMS in Beijing. Heading up the Asia-Pacific Lifesciences sector group, Nick represents high-profile companies and coordinates international patent enforcement and other intellectual property advice for a number of clients.

Dr David Pountney is a Lifesciences Lawyer and former Clinical Research Scientist at CMS in Beijing. David supports the fi rm’s Lifesciences Group, both in the UK and China, on a number of matters, including patent litigation, patent due diligence, regulatory matters, and mergers and acquisitions.
Nick Beckett
David Pountney
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