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International Clinical Trials

Culture Trip

The number of clinical trials conducted in Asia has more than doubled in the last 10 years and continues to rise. There are clear reasons for this. The region is home to nearly 60 per cent of the world’s population, which is both genetically diverse and has less access to the sophisticated treatment regimens available in the West. This vast number of available patients, coupled with faster start-up times, has clear advantages for trial sponsors.

Regulatory Complexity

As governments in the region increasingly see medical science as an economic growth area, their financial backing correspondingly increases. Although the regulatory environment continues to provide challenges, the situation – particularly among smaller Asian countries – is improving.

The plethora of regulatory bodies with their different strategies and priorities is at the heart of this complexity.

The Pan American Health Organization, the China State Food and Drug Administration, and the Ministry of Health and Family Welfare’s Drugs Controller General of India, for example, all enforce wide-ranging rules and regulations covering clinical trial approval processes. The relative immaturity of regulatory structures within the region makes execution of an integrated regulatory strategy difficult and local knowledge important.

Experienced, on-the-ground resources are critical to successful outcome of the strategy. As the markets mature, the situation will improve. Markets such as Japan demonstrate that government will, focus and money leads to more structured and organised regulatory infrastructures.

Despite the regulatory difficulties, however, the vast, genetically diverse population, significantly lower costs and improving trial infrastructures mean that many Asian markets are very attractive for trial managers and sponsors. And yet there are many hurdles to overcome – not least of which are the linguistic and cultural challenges.

Linguistic and Cultural Issues

The linguistic challenges at a basic level are clear. There is a significant level of diversity in Asia, with the area being home to more than a third of the world’s languages. The temptation to view English as the lingua franca in the region is a mistake. It is true that, in many countries, English is often used as the language of business, and many Asia-based physicians earn their qualifications in the US or Europe. However, in the less educated, generally poorer areas, it is not widely used or understood at all. Even in areas where English is widely used, access to patients can often be undermined without the correct language adaptation.

Although a generalisation, it is also true to say that Asian patients are likely to have a different attitude towards physicians than their Western counterparts. There are differing sociocultural groups in Asia, comprising Pacific Islanders, South East Asians and East Asians. Each group displays different traits, but there are similarities too. In particular, all can be said to differ from Westerners in the way they receive and process communication. One specific issue is the relationship between physician and patient. Asian cultures tend to be hierarchical, and physicians enjoy a high degree of deference and respect. This presents the risk that patients will blindly and unquestioningly follow their advice and recommendations. This is exacerbated by a lack of directness in communication styles. Asians tend to be high-context communicators – in other words, less direct than is usual in the US and Europe – which can make getting to the heart of a situation more difficult. Harmony in relationships is important, and passive acceptance of a situation does not necessarily equate to approval. Care therefore needs to be exercised in the translation of materials in the first instance, and in the analysis of data as the study moves on.

Country Examples

Some key features of the language and culture issues in certain Asian countries are given below, to give a quick overview of this complex subject. It should be noted that many of the cultural characteristics listed under one country are also present in the others. This is in no way a definitive outline, but it hopefully provides a summary of some of the differences to be considered in crafting communications and executing trials in the region.

Japan
The world’s third largest economy, Japan is a well-established market for clinical trials, with infrastructures and regulatory environments similar to the US and Europe. Consequently, costs are in line with those experienced in Western trials. It is arguably the most technologically advanced country in the world.

Japanese is the sixth most spoken language in the world, although very rarely used outside Japan. It uses Kanji characters, of which there are 1,945 officially endorsed (and over 6,000 in total), used in conjunction with Hiragana and Katakana.

Some cultural issues are worth noting:
● ‘Saving face’ – maintaining status and respectability – is important in Japanese society. People will go to great lengths to avoid either losing face themselves or causing someone else to. Turning down a request or openly criticising another person are examples of how someone may lose face, and will be avoided
● Harmony is a key value – in family, in business and in general interaction with other people. Japanese citizens are brought up to be acutely aware of the interdependency of all people in society. It is the polar opposite of an ‘individualistic’ society
● Age and status in society are revered. It is very difficult for younger people to openly disagree with an elder

China
China is the third largest pharmaceutical market in the world. Prevalence of a vast population and disease-specific populations make it popular for trial sponsors. An improving regulatory market is present, and increasingly the results are receiving approval in developed markets outside China. All healthcare documents must be submitted in Chinese or Mandarin. The language is standard Chinese or Mandarin, with other minority languages and dialects.

In terms of cultural issues, consider the following:
● The concepts of Guanxi and Cofucianism dominate a culture in which hierarchies and saving face are central
● The Chinese often rely on facial expression, tone of voice, posture and other non-verbal signs to convey meaning
● In general, China is a collectivist society, and citizens often subjugate their own feelings for the good of the group

India
Healthcare systems in India are not as highly developed as many Asian countries, especially away from urban conurbations. However, research costs are significantly less, and India does have a well-established pharmaceutical industry. The government is working to improve regulatory controls, while IT infrastructure is strong. There is a large population and spread of diseases, and also increasing similarities with Western disease patterns.

Although English is widely used in urban areas, there are many languages and dialects across the country. Different states have different official languages, and sometimes more than one. Ten languages have more than 25 million speakers in India. Hindi is spoken by a quarter of the population.

On the cultural side, the following should be noted:
● Indian culture is clearly influenced by Hinduism, but is very diverse with its myriad of languages and religions
● Society is highly status-driven, and relationships are influenced by an individual’s perceived position in the social hierarchy and that of the person they are interacting with
● Saying no is difficult for Indians. It is considered rude, and people will look for other less direct ways of indicating disagreement. Communication – both written and oral – is nuanced and punctuated by signs and symbolism

Thailand
The trial environment in Thailand is improving, with quicker approval processes and a developing hospital infrastructure. There is a rather drug-naïve population, only five per cent of which has access to private medical insurance, ensuring a ready supply of willing patients. The official language is Thai, although English is a widely-spoken second language among educated classes. Access to rural areas requires the use of Thai.

Culturally, the following should be taken into account:
● Thai people place great emphasis on politeness and respect. Personal self-control is a highly valued trait
● Society is very deferential, particularly (although not exclusively) through class groups
● There is a major Buddhist influence

Taiwan
This country has a well-developed healthcare system and at costs significantly below those experienced in the West. Compared to some others in the region, it has a relatively small population of 23 million. Decent education standards mean a good spread of pharmaceutical and biotech skills. The official language is Mandarin Chinese, although Taiwanese Hokkien (Taiwanese for short) is also spoken.

The following cultural issues are of note:
● Values are often based on Confucian ethics, which emphasise personal judgment and values over rules and regulations
● Guanxi also has a strong influence, driving relationships and the giving and receiving of favour (not always equal). Business is often completed on a who-you-know basis
● Women’s equality is improving

Localising Clinical Trials

The drive for more cost-effective trials is making Asia a popular destination for trial sponsors, although cultural and linguistic challenges alone provide good reason for caution. Research and preparation are key. Care must be taken to ensure that trial results are not compromised by poor use of language, or misunderstanding the cultural and behavioural considerations.

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Gary Muddyman is Managing Director and CEO of Conversis, a UK-based provider of globalisation, internationalisation, localisation and translation services. Gary leads the company’s strategic development, as well as overseeing a variety of other business interests across the group. Prior to joining Conversis, he spent 16 years working for London-based HSBC Asset Finance UK.
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