The Imperative of Accurate Translations in Clinical Research

With the increase of global clinical trials, clinical documentation is required to be accurately translated at every stage from lab to launch. Despite the administrative burdens and tight regulatory timelines that clinical teams face, accuracy cannot be sacrificed in life science translations. Not only does accurate translation help clinical research teams overcome language and cultural barriers for global reach, but it’s also essential to mitigate ethical concerns, avoid potentially costly penalties from regulatory bodies, and much more. 

With this in mind, let’s dive deeper into considering the risks and understanding the severity of impact when clinical research documents are translated inaccurately. 

Compliance 

Accuracy in clinical documentation translation is not just a best practice—it’s a requirement from global health authorities to maintain compliance. 

For example, in the EU, the European Medicines Agency’s Clinical Trial Regulation (CTR) guidelines require that all clinical trial documentation is translated into the languages that the trial participants speak. Furthermore, content submissions to EU authorities must be provided in the member state’s official languages where the trial takes place. In the US, the FDA’s 21 CFR Part 50 guidance requires that informed consent documents are translated in the clinical trial participants’ local languages, and the 21 CFR Part 312 regulation requires translated versions of all essential documents in the Investigational New Drug Application. Failing to comply with these requirements can result in warning letters, FDA and EMA fines, product recalls, and withdrawals of clinical trial applications. 

Patient Safety 

The rights and safety of clinical trial participants and patients must always be protected. Patient-facing clinical documentation, such as informed consent forms, study protocols, and patient information sheets must all be translated accurately to avoid misinterpretation, potential harm if safety information is incorrectly translated, and any violations of patients’ rights if informed consent forms are not fully understood. Accurate translations overall reduce medical error through the clinical journey and when the medication is on the market. Additionally, they help maintain trust among patients, HCPs, and regulatory bodies, which helps trials continue in the future with increased participation and retention throughout the study. 

Data Validity 

Inaccurate clinical translations can lead to inconsistency in trial reporting data, which can compromise the overall analysis and validity of trial results. By leveraging cutting-edge, AI-powered machine translation workflows, clinical teams can maintain consistency and accuracy across translated clinical documents, including patient information leaflets, marketing brochures, and regulatory documents. Centralized workflows can mitigate risk through version control, and translation memories automatically store previously translated segments of text, thereby reducing the error-prone and time-intensive process of manual translation. 

Conclusion

Clinical product development is a complex process that is further compounded by the addition of translation and localization requirements. However, teams that understand the risks involved with inaccurate translation can anticipate their language needs proactively and better control for any pain points. 

Looking to create a risk mitigation plan for your clinical translations? Reach out to the TransPerfect Life Sciences team today to get started.