Creating clinical trial documentation in multiple languages can be challenging. To ensure compliance with regulations, the translation of clinical documents such as Informed Consent Forms (ICFs) and Clinical Outcome Assessment (COA) measures needs to be conceptually equivalent to the original text and culturally adequate for the intended audience. Back translation in clinical trials is a robust linguistic validation tool that helps producing reviewed translations which communicate the exact same meaning as the original text, are free of semantic errors and have relevance to the target audience.
In simple words, a “back translation” is the translation of an already translated text back into the language of the original text, made without reference to the original text.
Because it focuses on the accuracy of the “forward” translation (the transfer of a written text from one (source) language to another (target) language) and “cares” less about the style, the back translation is a literal translation. Comparing it to the original text, one can verify whether the content of the original text has been fully implemented in the forward translation and if the intended meaning is clearly and accurately conveyed. Any errors, serious discrepancies and ambiguities in the forward translation are pointed out and addressed.
In terms of required qualifications, the back translator must be a native speaker of the source language and have an excellent command of the target language, while the knowledge of the target culture and subject matter is highly desirable as well.
The back translation review is usually overseen by a Project Manager with strong linguistic skills. It results to a revised forward translation and a back translation of the new forward translation. This “reconciliation” process is documented in a discrepancy report, showing what has been changed and why. The aim is to decide on an optimum final wording that correctly conveys the meaning of the original document.
Clients, such as pharmaceutical companies, medical device companies or Contract Research Organizations (CROs), and Language Service Providers (LSPs) use back translation as an additional risk management step for complex and highly sensitive documents (clinical and pharmaceutical protocols, medical reports, ICFs and patient questionnaires), where translation accuracy is key, and errors have major impact.
Additionally, some local regulatory bodies, such as medical ethical committees (ECs) or institutional review boards (IRBs), recommend the submission of foreign language documents along with their back translation, as an evidence that translations have undergone an independent proofing process.
In the clinical trial industry, ethical and legal considerations apply. The US regulations state that the information presented in the ICF, including, among other things, the risks and benefits from the participation to the clinical study, along with the patients’ rights and responsibilities, must be given in a proper language that is clearly understood by the subjects enrolled in a study (or by their legally authorized representatives). Otherwise, their consent will not be educated, and may not be legally effective.
Furthermore, the increasing shift from the site-centric clinical trial model to the globalized model of multicenter clinical trials, including diverse populations (from clinicians and site personnel to patients) speaking different languages, demands for culturally relevant and scientifically accurate translations. It therefore imposes the need for an effective linguistic validation process that can ensure the consistent and precise communication of information and interpretation of data collected in multicultural settings, across shareholders. The rigorous quality requirements applying to this process are easily understood given that critical decisions (e.g., treatment options) depend on the validity of data pooled through COA instruments usually developed in one language and then translated for global use, in different countries and languages.
Here’s why back translation works for translated material to be used in clinical trials:
The most obvious disadvantages are cost and time:
Moreover:
Taking into account the enormous waste of money and time, the possible damage to brand image and reputation, not to mention the direct and potentially harmful effects on human life, that can result from the misconduct of a clinical trial due to inaccurate translations, it would still be prudent to consider including back translation in clinical trials as an additional quality assurance step to the workflow, in order to eliminate language misinterpretations and vagueness in nuance.
Despite its limitations, back translation acts as a “window” to the forward translation, verifying the faithfulness of the translation to the original text. It guarantees that the translated content preserves the original meaning and intention, that it is equally reliable, valid, and effective as the original content, and that safety standards, as far as the linguistic part is concerned, are met. By doing so, it offers a return on investment and contributes to the successful implementation of multinational clinical trials.
If you want to learn more about our back translation services, visit our Life Sciences localization page.
Read also:
5 Steps to Success with Clinical Trial Translations
Informed Consent Translations: The Importance of Understanding
The Importance of Accuracy in Medical Translations – The Case Of Willie Ramirez
Why is language translation so crucial in clinical trials?
Linguistic Validation Services in Life Sciences Localization
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