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Translating with the target reader in mind is never simple. Not only does the translator need to transfer the meaning of the source text to the target language correctly, they also need to “hit” the target register just right. In short: the right message needs to be communicated in the right way. This is especially important when working with clinical trial documentation.
Broadly speaking, most clinical trial documentation falls into one of two categories depending on the target reader:
- Healthcare professionals (clinical trial protocols etc.): HCP-facing documents are written by and intended for healthcare practitioners and other industry professionals. They are normally full of medical/pharmaceutical jargon, which presents translators with various terminological challenges.
- Patients (informed consent forms, self-administration instructions etc.): patient-facing documents are aimed at the persons receiving the studied drug, or their carers. The main challenge when translating them is not the terminology, but the need to provide just the right amount of medical information in a way that lay readers can understand, with awareness of their needs and empathy for their mental state.
Clinical trials deal with cutting-edge substances, materials, approaches, and technologies. So the documentation may contain many new words and does not lend itself easily to translation, presenting another wide array of challenges to any linguist working with it.
Consequently, all translators of clinical trial documentation, regardless of the source and target language, have to find solutions to two main problems.
Translating with the reader in mind
Firstly, translators need to be aware of the differences in register and style between texts for healthcare professionals and patients. This difference in register is key for pharmaceutical marketing materials, but it might be even more important for clinical trials. Readers having vastly different backgrounds and knowledge of medical and pharmaceutical terminology naturally results in different translation requirements.
The documentation for healthcare professionals will naturally be more specific and demanding in terms of terminology; the vocabulary used will be tailored to them, which means that it will be as precise, descriptive, and concise as possible. It will also be objective (neutral in terms of emotions and factors such as gender, age, and ethnicity), impersonal, and factual. This is all in an effort to be efficient when communicating a particular message, but also to remove as many cognitive biases on the part of the reader as possible. The healthcare professionals need to understand the exact process of the trial and their precise role within it.
Patient-facing documentation will be much less terminologically demanding and will try to be objective as well, but not emotionally neutral. The patient documentation should show the reader (usually the participant in the clinical trial or their carer) that the clinical trial is serious, but they are being led through it with all due consideration and empathy, that the trial staff care about their wellbeing and hold their safety and lives in highest regard. It is in the best interest of everyone for both patients and the staff to be calm and positive throughout the process. Readers of such documents can be small children (as young as 6 years old) or their worried-to-death parents. In all cases, it is absolutely essential that the patient understands what will happen to them, what is expected of them, and what they can expect to happen.
For the translation process, this means that the two types of documentation will be translated:
- by one translator who is highly proficient in both required registers/styles and is able to switch between them easily (such translators are few and far between!), or, more often,
- by two translators: one highly specialised in medical/pharmaceutical documents tackles the texts for healthcare professionals, and the other well-versed in style sensitive translation (marketing translators are usually most proficient in this), taking on the patient-facing documents.
Both ensure the intended message is transferred to the target language in the appropriate way, i.e. using the style and/or register that guarantees the reader gets the message.
Translating emerging terminology
The second translation problem with clinical trial documentation is newly emerging or even non-existent terminology. Clinical trials are the next logical step for cutting-edge substances, technology, and processes being put into practice. Most trial documentation is written in English, a language in which the majority of the medical and pharmaceutical terminology is first coined. This then needs to be carefully translated into the target language, staying mindful of existing terminology in the given field, specific language rules for coining new words, and many other factors. New specialist terms also need to be explained in any language to patients who do not have the technical knowledge.
In cases like these, translators usually work closely with local medical and pharmaceutical professionals (including researchers) to make informed terminological decisions based on existing terminology and emerging vocabulary alike. Advice from people that will end up using the terms is priceless; the last thing any translator wants is to end up with a word no one will understand or use.
A recent example of how the translation community has coped with emerging terminology is the COVID-19 pandemic. Everyday conversations in all world languages were suddenly flooded with terms like prevalence, PCR, zoonotic, endemic, incubation period… While these terms were not new for the medical community, most of the population had no reason to know them before March 2020. Translators of scientific documents and reports had to work hand-in-hand with local scientists to determine the best way to translate these terms. The same goes for new terms as well that had no reason to be translated before.
Clinical trials are an essential step in the life cycle of many drugs and devices that will make all of our lives better or longer and increase our quality of life. It is important to facilitate their local and global success by providing translations that do them justice. Considering the amount of effort, dedication, and courage that goes into clinical trials, from both healthcare professionals and patients, it is only right to support them in any way possible.
Alamma proudly supports our partners from the pharmaceutical industry in performing potentially life-changing clinical trials. To do that, we rely on our selection of trusted language professionals and industry contacts to add to the Alamma knowledge base, thus ensuring our translations are to the point.
Are you looking for a trusted language partner to advise and work with you on your next clinical trial challenge? We’re here for you.