Clinical trials and observations are critical to the furtherance of humanity’s medical knowledge.

Today though, many clinical trials are conducted globally – spanning regions and cultures – necessitating the involvement of advanced language services to ensure all researchers and participants can communicate clearly.

This is beyond vital. After all, almost any information relating to a given trial has the potential to cause serious harm to trial participants if poorly understood:

Inaccurately translated Patient Quality of Life questionnaires may lead to faulty results. Poor translations of Study Protocols may lead to participants failing to properly follow instructions, with potentially disastrous consequences…

Not to mention the serious economic and reputational harm which can befall any organisation which conducts clinical trials and studies at anything less than the highest standards.

But with the number of clinical trials conducted outside their country of origin continuing to rise – it’s estimated that around 33% of the trials conducted by the largest twenty US pharmaceutical companies happen outside of the country, for example – the need to properly plan and incorporate the localisation of clinical trials and research is more vital than ever.

What do clinical trials and research involve?

Clinical research is medical research which involves people. In general, there are usually said to be two types:

1)Observational studies

During observational studies, the people involved in the clinical trial are observed during their normal life.

These observations may take the form of medical tests or exams and questionnaires. Generally, the goal is to see the effects of certain lifestyles or how people with generally similar characteristics change over time.

Many observational studies are designed to identify opportunities for where clinical trials might take place.

2)Clinical trials

Most clinical trials are designed to test the effectiveness of a new treatment, drug, medical device, surgical practice or lifestyle change. Others are designed to test ways to prevent health problems or test for the presence of a condition before it develops.

Before most human clinical trials take place, tests in the laboratory and on animals are common.

Why is language translation so important in clinical trials?

Clinical trials are vital for the advancement of the human race’s scientific knowledge. Unfortunately, not all of the human race speaks the same language.

In order for the often critical data created by clinical trials to reach the widest possible audience, this means that careful and effective localisation of the language used in clinical trials is vital.

This is because:

1)You increase the global information pool

A great deal of leading medical research is done and recorded in English. But there are also huge volumes in French, German, Portuguese, Spanish and numerous other languages.

If all the discoveries of every individual research team remained in restrictive silos of language, each study would need to be completed in every language.

Only by making discoveries mutually intelligible – to a fine degree of scientific description – is it possible for research teams working in different languages to learn from and build on each others’ work.

Simply put, anyone who wants to use the practices and procedures developed by researchers working in a different language needs to have access to them in a language they can understand.

2)It’s often a requirement of governing bodies

There are numerous governing bodies in the medical research field. These include groups like the European Medicines Agency (EMA), the World Health Organisation, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), the Food and Drug Administration (FDA) in the United States as well as other local government bodies.

Most of these bodies have language requirements. For example, in the US, all documents used by the participants and researchers involved in clinical trials need to be in English.

But whichever local body your research falls under the auspices of, the failure to comply with language regulations in clinical trials can be high. Loss of license and severe financial penalties are not uncommon.

3)You ensure trial participants have a complete understanding

A Clinical Trial Protocol (CTP) is the document in which a trial’s goals, methods, design and organisation are described. Without this clear base of understanding, the risk of miscommunication and consequent harm to participant health and study success are high.

CTPs are highly complex, specialised documents which require careful use of language in order to convey instructions with absolute precision. However, it’s important to note that a CTP may be intended for several different audiences.

Most obviously, a CTP may need to contain clear appended guidelines for communication and instructions for both participants and researchers. These are two groups which will have different levels of understanding of precise medical terms. Thus, the language used will need to be carefully tailored.

Of course, as well as CTPs, there are a wide array of other forms which trial participants need to be able to interact with complete understanding. These might include informed consent forms, data collection forms and many others.

4)You learn when you rephrase

If you speak another language yourself, you’ll be aware that the way to phrase any given message might vary wildly between two different languages.

This is a positive advantage when it comes to translating clinical trials. Sometimes, when a certain finding or sentence needs to be rephrased in order to transmit the same message in a new language, the new phrasing can actually be an improvement over the original.

This can result in a borrowed word being used in place of the original imprecise phrase. Or the original information simply being put in an easier-to-understand order.

5)You sometimes need to simplify

Linked to the above, when translating precise scientific details, most language specialists will recommend that you simplify rather than attempt additional long-winded explanation.

This can often lead to an improvement in the precision and simplicity of the original language used.

6)You make your research much more accessible for the future

As well as improving the reach of your research today, accurate translation of your results ensures that you have the greatest possible impact on your field tomorrow and on into the future.

The more languages your research is accessible in, the more likely it is for others to refer to it and build on it.

What’s the difference between direct translation and localisation?

When translating clinical trial and research data and documents, there is one important factor to bear in mind:

The direct translation of a particular term, word or phrase may mean something completely different when understood by someone from a different culture, country, market or region.

That’s why it’s so important that your clinical trial translation is an accurate localisation of the language involved – that it accounts for all variations in data, information, function, medical instrument design and all other local factors – rather than being a straightforward translation.

The former ensures clarity and understanding no matter who your trial participants are. The latter is a prescription for disaster.What’s the difference between direct translation and localisation?” Although the case for clinical trial translation is strong, the challenges involved in getting it done right can be equally so. They include:

1)Precise terminology and false friends

As an expert in the field, you’ll know how complex medical terminology can be. It’s also worth noting that there may be significant differences in the vocabulary and phrases used between dialects of the same language used in different regions.

This can include the words used to refer to diseases, side-effects, general states of health and a wide range of other factors. There are a huge number of horrifying examples where poor translations – relying on things like false friends – resulted in terrible patient outcomes.

As you’ll know, in medical translation, there is no room for even the smallest of errors.

2)Bridging cultural boundaries

Often in medical studies, the larger the patient pool, the better. A range of racial and environmental backgrounds and more can dramatically increase a study’s value.

However, communicating clearly with people from different regions and cultures requires even greater clarity and precision in terms of the language used. As we’ve noted, it’s not just a case of finding the exact word-for-word translation either:

i) Cultural sensitivity to personal issues

There is a wide variety of terms and phrases which might seem completely innocuous to someone from your home culture, but which someone from one of the cultures in which your study will take place might find confusing or deeply offensive.

This makes adapting your trial materials to be acceptable or understandable to someone from a different culture vital. That’s a key role which localisation plays.

ii) Deeper cultural understanding

As well as differences in language, many cultures display differences in terms of how they follow trial instructions.

To use a sweeping generalisation, it is sometimes remarked that clinical trials in Japan tend to display high levels of participants who follow all trial instructions very strictly and well. However, they also tend to find larger numbers who will seek to hide negative outcomes and side-effects.

This can be important when understanding what a participant is really saying during their debrief, for example. When someone from a certain region says they are “fine”, they might not mean exactly the same thing as someone from somewhere else.

A good LSP, with experts drawn from the culture in question localising your trial materials for you, will be a vital resource to call on here.

3)Quantity of documents

Some clinical trials may last only for a few weeks or months. Others – especially those testing new medication – may last for ten or more years.

Any length of study can produce huge quantities of documents, however. All of which require careful, precise translation if they are to be of any use.

This sheer quantity of documents can be a challenge for any team of medical translators. It’s one of the major reasons why having your language team involved in the trial from the early stages will produce better results – as we’ll move onto in our next section…

How to translate clinical trials and research

Now that we’ve gone over the challenges involved in the translation of clinical trials and research as well as the reasons to do it, let’s take a look at some sensible steps to take when it comes to how to do it:

1)Have a strategy

Quickly “tacking on” medical translation services to a clinical trial or research project at the last minute will make it much more difficult for your language team to achieve the results you will be looking for.

You will get the best results by working with your LSP from the very beginning, allowing them to make suggestions for how they will be best able to meet your needs.

This makes it vital that you…

2)Choose the right LSP

Not all Language Service Providers are created equal. You will need to look for one with:

  • Extensive experience: or a proven specialism in clinical trial and research translations.
  • Subject Matter Experts: these will be professional translators who have experience or qualifications in life sciences. For example, Asian Absolute only ever selects translators with at least five years of industry experience and/or Masters degree-level qualifications or greater for these projects. Many of them are – or have been – practising medical professionals themselves.
  • Native language expertise: you will always want your translation team to be translating into their native language.
  • The right translation tools: technological tools such as Translation Memories ensure the consistency of terms across even lengthy clinical studies. Make sure that your LSP uses them.
  • Experienced editors and proofreaders: editing and review by highly skilled professionals with experience in clinical trials is a vital step in ensuring the quality of the final output. In fact, you should…

3)Insist on linguistic validation

Linguistic validation is a key term in the field of medical and life sciences translation. Straightforward review by an editor and proofreader are rarely sufficient for documents as important as those associated with clinical trials.

Steps such as back translation and reconciliation, cognitive debriefing and harmonisation of responses are common features of the linguistic validation process. The end-goal is to ensure that the data is consistent no matter what language it was produced in or read in.

Several key industry bodies – such as the International Society for Quality of Life Research (ISOQOL) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) – have their own standards which every trial needs to meet. Linguistic validation is a critical step in achieving these standards.

4)Build-in integrated translation processes

You will want your LSP to be able to handle all aspects of the translation required by your trial. From pre-clinical studies to Study Protocols to Clinical Outcome Assessments (COAs) to Patient Quality of Life Questionnaires (QoLs) to Serious Adverse Event Reports to Ethics Committee Submissions.

Only be ensuring that all of these processes and needs are met by the same team using the same centralised Translation Memory system will you ensure consistency and coherence of terms across your trial.

5)Create a glossary of terms

If your LSP doesn’t insist on working together to create a glossary of terms, you should take it upon yourself to do so.

A terminology base like this is vital for getting the best out of tools such as Translation Memories. You might want to compile one using existing translations already approved from previous trials or projects, those garnered from approved public databases as well as other source materials.

Agree to the correct translations of all key terms with your language team in advance and you’ll reduce translation costs as well as time.

6)Concentrate on security

It’s always worth checking the security measures your chosen LSP has in place to protect the often sensitive data that you will be entrusting them with.

For instance, Asian Absolute uses the kind of data security you’ll encounter when dealing with international banks. That’s on top of the Non-Disclosure Agreements our translation teams sign and the highly experienced, ISO-certified project managers responsible for monitoring all security protocols.

Clinical trial localisation – where to start

Localising the complex, medically-critical language used in clinical trials and observations can be a challenging process if you don’t plan the integration of the translation process from the very beginning.
But by choosing the right Language Service Provider as your partner, you’ll be all set to get any advice you need as well as a precise, accurate and culturally accurate translation of all of the language used in your clinical trial.

Asian Absolute’s clinical trial translators are often practising or former doctors. This gives them the deep subject matter knowledge they need to guarantee accuracy.

Contact us today. You can find out more about using us for your upcoming clinical trial, request some more information or get a free, no-obligation quote at any time.