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  • Writer's pictureAna Sofia Correia

The role of translation and linguistic validation

Updated: Nov 1, 2022

Translation and linguistic validation play a vital role in amplifying the patient’s voice by ensuring that all patients are equally heard, regardless of the language they speak or the country they live in.

Capturing the patient’s voice in translation - Part One: The role of translation and linguistic validation

In August, I had the pleasure of hosting a Multilingual Summer Series panel with Anna Richards, Kokoro Yoshikawa, and Trishna Baradia about “Capturing the patient’s voice in translation.”

This is the first part of a series of articles I am writing on the topic, entirely derived from Anna, Kokoro, and Trishna’s insights:

Part one – The role of translation and linguistic validation

What does “patient’s voice” mean?

When talking about the patient’s voice, we’re talking about anybody interested in making sure that the experiences and clinical outcomes for somebody who’s been diagnosed with a condition are going to be as positive as possible.

The patient’s voice might include the patient, a caregiver, a family member, and everyone involved in the patient’s care. It’s about ensuring that that person’s wants and needs are heard throughout their healthcare journey.

Within the medicine development lifecycle, it’s about how patients are treated within clinical trials, their unmet needs, and the research priorities. It also concerns the way clinical trials are designed to make sure they get the best out of the people who are taking part in them.

Linguistic validation in clinical trials

Linguistic validation is usually carried out on Patient-Reported Outcome (PRO) measures. These are questionnaires or diaries completed by patients within clinical trials or studies looking to capture patient data.

Hearing patients, regardless of the language they speak, is becoming increasingly important as there are more and more clinical trials being run in multiple countries. PROs need to be comparable to make sure that the captured data is comparable between countries.

You need to ensure that what you mean in one country is the same as what you mean in another country. As it becomes easier to run trials on a global scale, this will become even more important.

What you ask in PROs is incredibly important because if it’s mistranslated, your data is wrong. Then you’re not going to get the intended outcomes, or you won’t have accurate data. Quality will be impaired, which could essentially cause the whole trial to fall through.

Making information accessible to non-English speakers

In every clinical trial, the cultural nuances of any translated material have enormous importance. It’s essential to create genuinely multilingual and multicultural content, from patient engagement materials, through informed consent forms, to end-of-study reports.

It’s crucial to ensure that people who speak other languages are fully informed about the clinical trial process and given the information they need to make informed decisions.

To a certain extent, medical translators end up taking on the role of patient advocates because it’s not just a matter of translating the text. You have to think and put yourself in the patient’s shoes.

Translators act as a vehicle to help and support patients. As linguists, we consider all sorts of information as well as the circumstances and the context. Therefore, it would be highly beneficial to involve translators in meetings during the early stages of content development.

We have to keep in mind that not every single patient community is the same. You have some patient communities that might be large, but others may be pretty dispersed. You see this with rare diseases, where few people can share the information because few people have that condition.

Some patient communities are known as being highly activated, very forward, and open about the condition. Others are much shyer and much more closed. This is fundamental to understand because if all you’re doing is a straight translation, you’re not taking into account the target audience and making sure that all of those sensitivities are being taken into account.

One of the ways that we can help overcome this is by making sure that sponsors, clinical research organizations, and patient organizations are really making connections with those within the communities. Only by identifying people who can act as mediators, who can help produce information in the target languages, we’ll get the information and have the patient’s voice heard.

It’s not just a case of developing materials in English and then have them translated. We also need to make sure that those cultural nuances and sensitivities are considered when the information is being produced in those different languages.


Ana Sofia is an English to Portuguese medical translator and writer working with Life Sciences companies, Contract Research Organizations, and Medical Communication agencies. She has experience translating and writing content for clinical trials, medical devices, regulatory submissions, education and marketing campaigns, and scientific publications.


Med & Mark - A blog about medical and marketing translation
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