Introduction: The Vital Role of Medical Translation

Many clinical trials 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 localizing clinical trials, so the data can be gathered, researched, and made available across borders is now a vital necessity.

The Consequence of Language Errors

Time To Market Delay

Incorrect language does not need to result in an accident that is damaging to your company. If even just a few patient records from a new drug trial in Europe are misinterpreted by the US pharmaceutical company because of language errors, the outcome might be skewed just enough to make the difference between getting an “Approved” vs. “Non-Approved” letter from the FDA. Even if language errors are caught by the company, finding and correcting them may cause delays in the completion of a clinical trial.

Patient Behavior and Adverse Effects

Accurate language and its intent also has an impact on patient behavior, both during and after the clinical trial is completed. According to the NIH, faulty translations may cause the “failure of the participant to act as instructed, disparities in prescription and administration of the study preparation, and reduced likelihood for appropriate follow up and treatment of the underlying conditions and/or of side effects of the trial.”

Compliance Issues

Regulatory affairs encompass the procedures and actions to ensure compliance with safety, efficacy, and quality standards set forth by relevant authorities for medical products. As such, regulatory affairs and translation are closely intertwined, as regulatory compliance requires accurate and timely communication of information in multiple languages. Most regulatory authorities require that medical companies submit documents in multiple languages, which can be challenging given the complex and technical nature of the information. Accurate language preserves the intended meaning of clinical documents, and provides all stakeholders with access to the information necessary for making informed decisions.

Translation vs. Transcreation

According to Slator, while both Translation and Transcreation involve transferring content from one language to another, Translation focuses more on word- and sentence-level accuracy, whereas Transcreation seeks to reproduce the aim and effect of the original message in a new way deemed completely natural in the target language and culture. The goal of Transcreation is to keep the same intent, style, tone and emotion of the source material in the target language, and is the best methodology to utilize to maximize the intent and thereby accuracy of medical translations.

Important factors when researching your options:

Transcreation Should Be Completed Only Into The Native Language

It is not enough to be bilingual. To maximize accuracy, transcreation should be performed by people who were born into and think in the target language.

Transcreation Should Be In-Country

An in-country transcreator is immersed with local culture and context of your clinical trial, and can best communicate in ways that are relevant and important to the participants and researchers involved.

Transcreation Should Be Performed By A Medical Content Expert

Transcreators must be medical experts in the information that is being localized. If they do not understand the intent of the material, the transcreation will not be a success.

Transcreation Should Be By Professionals With Copywriting Expertise

Good transcreation involves good writing. You want only want to utilize professionals who can understand your global trial goals, while tailoring your message to best connect with local participants.

Conclusion

The impact of language errors in clinical trials can be significant, leading to confusion for the participants and researchers. These frustrating events can lead to dropouts, delays in execution timelines, and even affect the validity of the ultimate trial results. Because of this, regulatory agencies now require that global clinical trials are accurate, consistent, and culturally appropriate in each of the local countries they are administered.

Investing in high-quality transcreation services can be a major differentiator for a successful clinical trial, by ensuring regulatory compliance and improved patient outcomes.

Click here to learn about Language Scientific , and our unique approach to all your medical transcreation needs.