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International Clinical Trials

Language Barriers?

Africa is assumed to be the origin of humans, but so far this head start has not given the continent many advantages. With around one billion people, Africa is home to about 14 per cent of the world’s population. However, research shows it also has around 25 per cent of the world’s disease cases and, perhaps most tellingly, these have to be treated by less than three per cent of the world’s doctors and nurses.

This is a follow-up to an article that was published in International Clinical Trials (August 2011, page 76) about African languages and their roles in clinical trials.

Translation: Expense or Investment?

More and more clinical trials are being organised in countries across Africa. The reasons are obvious: there are lots of potential subjects who do not need much money; the infrastructure is getting better in many cities; and doctors like to participate as the trial fee complements their often meagre income and they may learn new skills. A more cynical view could be that in some African countries, health authorities are more lenient than in the US or European Union (EU), and also that participants do not quickly complain, because they get medicines, a physical check-up, a meal and perhaps even bus money for showing up.

When conducting trials in Africa, there are two strong reasons for language translation. First of all, even though English or French are the official languages of many countries, this does not mean that everybody speaks or understands them very well. In order to include many people with varied backgrounds (and not merely the elite), translation is essential. The second reason to translate is that valuable research data may have to be excluded if it becomes clear that participants did not fully understand the information they have consented to, or the questions they were asked to answer, because these were in a language they did not fully comprehend.

Translation is a must in order to undertake research in countries where people do not speak English. It is usually not expensive either; translation costs are lower for African languages than for European ones, but the difference in itself is not important, as translation represents a relatively small cost item anyway. Compared with the total trial costs, it does not make much difference whether the translation of the trial documents costs $800 or $1,500 per language. More importantly, translation should be regarded as an enabler to reduce the cost of the clinical trial because it makes it possible for the trial to take place in low-cost countries. As such, it should be seen as an investment. The salary cost of a full-time trial nurse in Africa is between $200 and $600 per month, depending on the country, whereas a staff member in a country in the EU would likely cost five times that.

Understanding English and French

Many organisations believe that when you have trial documents written in English and French (and perhaps Portuguese) you can quite easily run trials in most parts of Africa. In a way that is true. Many people in west African countries have a good command of French; in east Africa the same is true for English, and in a few other countries Portuguese is one of the official languages. The terms ‘Anglophone Africa’ and ‘Francophone Africa’ are misleading, though, as they suggest more understanding than can be justified. Addressing people in English or French may work well in formal communication and in contacts with governments, but when one brings more technical English or French health information to Africa, it will be understood only by the elite.

In Kenya, for example, it is estimated that less than 20 per cent of the population speaks English well enough to understand vital information concerning consumer rights, democratic rights and health. This means that more than 80 per cent of the Kenyan population (of 43 million) does not sufficiently understand such information. When asked, most Kenyans will claim to speak English. It is one of the national languages and few people would admit that their command of English is actually quite poor. Educated people, and those who are in contact with others a lot, do speak English (as well as Swahili). However, most ordinary people in Kenya primarily speak their mother tongue (one of 69 different local languages), because that is the language they use every day, and Swahili, which is widely taught in schools.

What about Swahili?

In east Africa, more than 100 million people speak Swahili. For almost all of them, Swahili is the second language, used to communicate with people who speak a different local language. Only 5 million people (mainly living along the coastal regions) speak Swahili as their mother tongue. In Kenya and Tanzania, Swahili is one of the offi cial languages, together with English, and it is widely used in seven other countries in east Africa, although not as a national language.

When looking at language maps of Africa, it becomes clear that the Swahili-speaking world covers an area where well over 200 different local languages are spoken (69 in Kenya, 129 in Tanzania, dozens more in the relevant parts of the other seven countries were Swahili is spoken). In an area with so many different languages, using just one is crucial. Without such a lingua franca (a ‘bridge language’ for people who do not share the same language), communication would be much more complicated and trade would be more diffi cult. Actually, trade has been the driving factor in the spread of Swahili over the area. There is no doubt that using one language has been an important factor in the development of the region.

Unless a CRO prefers to recruit participants from a welleducated elite only, English trial documents will not be effective. Using Swahili versions of the informed consent form, questionnaires and other trial documents is a very important first step. If no local languages are available, having these documents in Swahili will make a big difference. Even when participants have no highly-developed Swahili skills, these translations are still useful as, for local trial staff, it will be much easier to provide local language explanations on the basis of a Swahili version than an English version.

And one could go further than Swahili alone. Six of the 69 local languages of Kenya together cover 90 per cent of the population of the country, including languages such as Kikuyu (spoken in central Kenya), Kamba (east) and Luo (west). With translated versions of trial documents in these six major languages, the vast majority of the Kenyan population can be reached.

Translator Shortage

In Africa, more than elsewhere, the importance of translation is underestimated and the work of translators is grossly undervalued. In poor countries, studying a language is considered a luxury, and talented people with a good command of languages get easily drawn into other professions – for example, careers with an international component. Translators find it hard to make a living. When they work for the government, they may have to wait far too long until their invoices are paid, and they are often forced to work for a very low rate. Practically all members of the Kenya Interpreters and Translators Association do translation on the side and have a different ‘day job’. Translation is often done by people who are not (or not optimally) equipped to do the work; a lot of it is done by people who work in education or in the news sector.

It is safe to say that in Kenya, as well as in several other African countries, there is a shortage of translators. So, who will be doing the work for trial organisers? As in most countries, there are translation agencies around, but only a limited number; in the Yellow Pages for the whole country, there are seven listings. However, even with seven agencies that are easy to find, this might work. In any event, one has to make sure that potential translators are able to understand both the language and the medical side of trial documents.

Swahili Medical Translation Centre

Specifically for healthcare translations, the not-for-profi t organisation Translators without Borders (TWB) has recently set up a translation centre in Nairobi, Kenya, where people with strong language skills receive intensive training to equip them for the translation of health information into Swahili. TWB is the only non-governmental organisation (NGO) that specialises in providing free translations to humanitarian organisations; these translations are done by around 1,500 volunteer professional translators, who donate some of their time and skills to around 85 NGOs. Part of TWBs mission is to create translation capacity where needed, and the Swahili-speaking world was selected for its pilot centre. The centre in Kenya was set up to provide translation services (almost for free) to humanitarian organisations. Trainees work on Swahili versions of general health information for consumers, as well as training manuals for community health workers – in Kenya, the lowest level in the medical hierarchy – who are in direct contact with the population. Translations are done by combining language and medical skills, and the teams are supported by a medical translations firm in Europe. The translated content is often printed or published via websites, but it is also used in health apps, allowing health workers ‘in the field’ to find information about specific health-related topics and to share that with the people they care for.

The centre has developed into a specialised translation unit dedicated to healthcare. It is also used, at a somewhat more commercial rate, to translate questionnaires, informed consent forms, protocol summaries, and other trial-related documents for CROs and pharmaceutical companies. Some of the trainees will be able to set themselves up as freelance translators, making place for new trainees. Over a period of 36 months, the TWB centre expects to have trained well over 50 different translators, thereby reducing the shortage of translation capacity in Kenya.


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Simon Andriesen is CEO of MediLingua, based in The Netherlands, which specialises in translation, localisation and testing of pharmaceutical, clinical trials, biomedical and medical technology information. He is a board member of the Life Sciences Roundtable at Localization World, a series of high-level conferences on translation and localisation, and is a frequent speaker at events. Simon has designed and is teaching a Healthcare Translators’ Training Course for developing countries.
Simon Andriesen
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