Introduction
Many clinical trials these days are global in nature. Patients recruited into the trials, as well as the researchers conducting the trial in their country of origin, usually do not rely on English as their primary language. As such, the importance of translating and validating clinical documentation, so the data can be gathered, researched, and equivalently harmonized across borders is now a vital necessity.
(Read more about this: Making Medical Translation A Differentiating Factor For Successful Clinical Trials.)
Linguistic validation is the process by which a patient questionnaire is simultaneously translated by different translators, both translations are reconciled into a single version and then that version is back-translated by other translators into the original language to evaluate the quality of the reconciled translation in comparison with the source document.
(Read more about this: What Is Linguistic Validation.)
In this post, we will explain why Linguistic Validation matters, what are some of the challenges your organization will face and the benefits you will gain.
Why Linguistic Validation Matters
Without linguistic validation in clinical trials, there is a risk of miscommunication due to cultural and geographic nuances, leading to inaccurate data. Linguistic validation ensures that patient-reported outcomes are satisfactorily collated across different countries, their languages and unique cultures.
There are four key reasons why linguistic validation matters:
- Ensuring Accurate Communication
Poor translations can distort patient responses. By ensuring that patient-reported responses are linguistically validated, clinical trial leaders can gather accurate, culturally relevant data that truly reflects patient experiences.
- Cultural Relevance
Certain phrases related to health can have different interpretations across different geographies. Linguistic validation ensures that translations account for these differences, making the protocol relevant and easy to understand for patients across the world.
- Enhancing Patient Engagement
When patients feel that clinical trial protocol aligns with their personal experiences, they are more likely to provide genuine, meaningful responses.
- Improving Data Validity
In globalized clinical trials, ensuring consistency across languages is crucial for data comparability. Linguistic validation harmonizes across translations, so all participants answer the same questions with equivalent meaning.
Key Components of Linguistic Validation
The goal of linguistic validation is to ensure that all components of the questionnaire have the same construct value and are conceptually equivalent across multiple languages and locales. Linguistic validation is a critical step to guarantee translation quality, and has three key components:
- Forward Translation and Back Translation
Forward translation is the first step for ensuring accurate and culturally relevant translations of clinical documentation. It is the process of transforming the source language into a target language.
Back translation serves as a quality control measure that helps to evaluate and edit the forward translation, by re-translating the translated document back into the source language. This validates the accuracy of the forward translation by getting a linguist who was not involved with the original translation to see how they understand it.
- Cognitive Debriefing
Cognitive debriefing is an important step in linguistic validation that involves testing a translated patient questionnaire or other such patient relevant clinical documentation with a small group of participants from the targeted patient population, validating that they understand the translated content equivalently as with the source language. This human-intensive step is meant to produce translations that are conceptually the same to the source document and language.
- Language Harmonization
According to the University of Michigan, “…language harmonization is the process of developing a common version (vocabulary or structure) across questionnaires for different regional varieties of a ‘shared’ language…it is important for countries or locations that share a language to take steps to avoid unnecessary differences across their questionnaires.
The regional standard variety of a language used in one country usually differs to varying degrees in vocabulary and structure from regional standard varieties of the same language used in other countries. Often differences relate to vocabulary and pronunciation, but differences in syntax and other grammatical features of the language are also found.”
Challenges In Linguistic Validation
Linguistic validation projects can be extremely challenging, as they require meticulous translation work. Any mistakes could cause documents to be rejected by the relevant regulatory bodies if being used for clinical trials. There are three major reasons such rejection can happen:
- Cultural Differences
Adapting translations to use language that remains culturally appropriate for the target patients’ cultures is a primary challenge requiring linguistic validation. It ensures clear understanding of the translated product as well as providing comparable data collection across languages and cultures.
- Technical Terminology
Technical terminology challenges in linguistic validation include accurately translating technical terms, which are crucial for clarity in communication in specialized medical fields. They involve evaluating the quality of available resources, consolidating terminological data, and choosing the right words or phrases.
- Regulatory Requirements
Regulatory bodies like the FDA require proof that translated documents have undergone linguistic validation in clinical trials to ensure their reliability and consistency. It is most important to follow their established processes, to stay compliant with these regulatory requirements.
Benefits Of Linguistic Validation
Linguistic validation ensures that the message sent is precisely comprehended. It delivers the following three benefits:
- Increased Patient Engagement
Without linguistic validation in clinical trials, there is a risk of miscommunication and cultural misunderstandings. When patients feel that the questions in the assessment documents align with their experiences and backgrounds, they provide genuine, meaningful responses.
- Better Compliance with International Regulations
Failing to meet in-country regulatory requirements can result in trial delays or rejections. With effective linguistic validation, research organizations not only meet regulatory standards but also ensure high-quality patient data collection.
- Enhanced Quality of Clinical Trial Outcomes
In global clinical trials, ensuring consistency across languages is crucial for data comparability. Linguistic validation helps ensure that clinical documents are clear, engaging, and relevant for patients, contributing to better trial data assimilation and outcomes.
Conclusion
Linguistic validation is integral to ensuring accurate, culturally relevant data collection in globalized clinical trials. Organizations can ensure that they collect reliable data that truly reflects patient experiences, regardless of language or culture.
At Language Scientific, we are recognized as experts in effective linguistic validation. Our global team ensures that your Clinical Outcome Assessment (COA) translations are accurate, culturally appropriate, and fully compliant in-country.
Contact Us to learn more.
