In summary: Linguistic validation in clinical trials differs from regular translation as it focuses on conveying the exact meaning of concepts, rather than word-for-word translations.
The market is expanding: The global clinical trials market is expected to reach $84.43 billion by 2030 – Linguistic Validation is needed more now than ever.
Humans rule: Human translation is preferred over Machine Translation.
Investment in training: There’s a growing need for more training resources and industry collaboration to meet expectations.
As the global clinical trials market continues to grow, reaching to an expected USD 84.43 billion by 2030 according to Canada-based organization Precedence Research, the need for high-quality linguistic validation in the medical field becomes increasingly significant.
In fact, a recent Life Sciences round table discussion, featuring various linguists, medical translators, and professionals in the industry, including our very own Rafa Zaragoza, gathered to discuss the importance and challenges of linguistic validation in this rapidly expanding market.
What is linguistic validation?
The main goal of linguistic validation in clinical trials is to accurately transpose clinical scales and instruments (any tool or set of instructions that go through the linguistic validation process, such as questionnaires or visual scales) into other languages so that the results are comparable. This process differs from regular translation, as it focuses on conveying the exact meaning of concepts across different cultures rather than word-for-word translations.
For example, if a survey asked, “how bad do you feel,” linguistic validation would involve finding the best way to convey the same sentiment and meaning in another language and culture, ensuring that the question is understood and interpreted consistently. This process helps maintain the integrity and comparability of the data collected in clinical trials, allowing for more accurate and reliable results.
Risks to consider
The challenges of linguistic validation aren’t just limited to language and concepts alone. The panelists emphasized the importance of avoiding ambiguities, ensuring conceptual equivalence, and managing risks in processes, vendor recruitment, and training.
Rafa explains that risk needs to be mitigated throughout the entire workflow, including processes:
“…We want to make sure that everything that we’re doing, all these steps that we are taking into consideration, is so that we can present data to health authorities and make sure that all this data that has been gathered is reliable and comparable.”
From a risk perspective, this means monitoring risk management and assessment of processes, including vendor recruitment and training of linguists to conduct effective linguistic validation in clinical trials. The more information and preparation translators have, the better the translation outcomes, especially when understanding the target audience and their cultural and social backgrounds.
Proper preparation and understanding of the target audience are essential in medical translation, especially for patient-facing documents. Clear communication among translators and ensuring readability and accessibility for people with various educational backgrounds and reading levels are vital.
But what about Machine Translation?
The panelists unanimously disagreed with the idea of using Machine Translation, citing the high risk of inaccuracies, lack of cultural sensitivity, and the ultimate need for human post-editing.
Participants emphasized the importance of maintaining an audit trail and considering the rationale behind the translation choices. They also reinforced their disagreement with using MT in the process. The panelists also touched on the consolidation process, where two forward translations are combined in linguistic validation.
Other challenges discussed include amending linguistically validated and copyrighted documents and training in linguistic validation. Interestingly, when working with such documents, changes can only be made to the amended part, not the entire content.
They also acknowledged the lack of available training resources and suggested that LSPs, in-house positions, and specific associations could help fill this gap. As experts in Life Sciences, we recognize this as an essential part of ensuring high-quality linguistic validation processes and outcomes, including the effective measurement of quality and mitigating risk.
If you want to learn more about the subject, you can watch the Life Sciences round table discussion below. By staying informed and engaged with the latest developments in linguistic validation, we can contribute to the ongoing success and growth of clinical trials and medical research, ultimately leading to better health outcomes for people worldwide.
Part 1
Part 2
