As its name suggests, linguistic validation is a process used to ensure the translated content of Clinical outcome assessments (COAs), and especially patient-reported outcomes (PROs), is conceptually appropriate and linguistically valid to truly reflect what the patients are communicating.

This type of service is essential in the medical sector due to its difficult technical content in the areas of biotechnology, pharmacology, and healthcare. It is also very necessary in clinical research trials, which without this service may be at risk of rejection due to poor translation of medical instruments or misunderstanding by patients.

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Why is Linguistic Validation an important process in Clinical Research translations?

Above we have highlighted the incidence of linguistic validation in clinical research trials. This is why its importance lies in guaranteeing researchers that the translated content is faithful to the source text and that it can be understood in different language groups depending on its application. Similarly, its relevance lies in ensuring that the content has been adapted to the target cultures.

In the medical sector, linguistic validation is used as a technique for reviewing the accuracy, reliability, and equivalence of results provided by patients. This evaluation is developed by them through questionnaires, forms, or interviews where patients help to verify the functionality of different treatments. 

For the due process of this information, ISPOR (International Society for Outcomes Research and Pharmacoeconomics) introduced 10 steps of good practice principles for the process of translation and cultural adaptation of patient-reported outcome measures (PRO).

However, out of the 10 steps of the whole process, there are a few in particular that are worth highlighting. Let’s look at them:

Linguistic Validation process

Forward translation

This first step requires the participation of two professional translators native to the target languages and with subject matter expertise in the medical field. This is when each prepares a version of the text that will then be submitted for review by a third party.

Reconciliation

This is where a linguistic validation expert comes in and, after checking the accuracy of each text, chooses the best version of the two translations, thus creating a third version. The goal is for the reconciled version to be a combination of the best attributes of the two translations. 

Back translation

In this step, the reconciled version of the content is translated back into the language of the source text. This translation is done by a native linguist in the language of the original document, who has not been exposed to the previous versions. The translation of the previous versions is necessary for quality control and to detect any divergence between the original questionnaire and the existing target version. 

Harmonization

The back translation is then compared with the original document and checked for differences. Based on this analysis, the relevant changes are applied to the target language versions and the final version is produced.

Cognitive Debriefing

Once this linguistic validation phase has been completed, it is normal to retest to ensure that the respondents at the target sites interpret the responses and find an equivalence of meaning. It is then that the clinical trial questionnaire undergoes cognitive debriefing to complete the linguistic validation process. This step is performed when required. It comprises recruiting respondents (general population, adults, both genders), and conducting interviews to test the new translation on a small group (5 to 8 respondents).

Since clinical trials are conducted on a global scale across the Life Sciences sector, getting it right from the start can help avoid costly repetitions later on. Translation errors can waste time and money, and when it comes to the medical field, particularly in clinical trials and clinical settings, time is of the essence and should ideally not be wasted on continuous corrections. 

That is why when it comes to linguistic validation, you must hire the services of a professional translation company with verified experience in the field. At Win & Winnow, we have many years of experience in translation services and are proud to have a highly qualified team to provide comprehensive solutions that help our clients reach their multilingual communication goals.

If you would like to access comprehensive language solutions for your pharmaceutical company, contact us today for a free evaluation and quote!