Nowadays, it is standard practice for clinical trials to be conducted across multiple geographical locations. Many companies do so to ensure the diversity of their patient population, speed up patient recruitment, and help fast-track authorisation from national agencies. With regard to rare medical conditions, sponsors may have no other choice but to go global to secure the necessary number of participants. In multinational studies, patient-facing materials such as questionnaires and informed consent forms (ICFs) need to be translated into the relevant language(s). Doing so not only guarantees participants fully comprehend the risks, benefits and instructions involved, but also ensures that the trial sponsor is in compliance with regulatory requirements. This is because national agencies, including Europe’s largest medicines agency BfArM, stipulate that documentation must be provided in the local language.
Avoiding errors in multilingual clinical trials
When it comes to translating in a clinical trial context, accuracy is vital. Errors can have a major impact on patient safety, the credibility of the trial, and ultimately the regulatory agency’s decision to approve your product or not. The safest method of avoiding such mishaps is what is known as Linguistic Validation (LV). Linguistic Validation is a complex, multi-layered process that involves multiple rounds of translation and review by language specialists, patients and clinicians alike. The content subject to translation and review are Clinical Outcome Assessments (COAs), which evaluate how a patient feels or behaves and show how the treatment is working. COAs can be broken down into four broad categories:
- Patient-reported outcomes (PROs)
- Clinician-reported outcomes (ClinROs)
- Observer-reported outcomes (ObsROs)
- Performance outcomes (PerfOs)
The workflows involved in linguistic validation
The very first step of LV is a translatability assessment, where experienced linguists review your original documentation to see whether there are any errors or potential issues that could arise in the translation process that should be ironed out before said process starts. Such issues could relate to ambiguities or cultural appropriateness.
Once the documents are given the green light for translation, the dual forward translation takes place. Here, two life science translators, independently from one another, translate the text in question. The two resulting translations are then subject to reconciliation by third expert linguist, who takes the best elements from the two translations, merges them together and proofreads the reconciled version for accuracy and cultural sensitivity.
This unified version then undergoes back translation into the original language by a fourth translator. To avoid any undue influence, this linguist has no sight of the original text. This is a quality assurance method that can identify any discrepancies between the reconciled translation and the original and it confirms that the meaning and conceptual accuracy have been maintained. Essentially, this step ensures nothing has been “lost in translation”. If any discrepancies are found, the reconciled translation is amended accordingly.
Following on from this are the clinician review and cognitive debriefing. The former involves a qualified in-country healthcare professional (HCP) reviewing the translated texts to confirm they are accurate, intelligible and culturally appropriate for the target patient population. Cognitive debriefing, meanwhile, is when the text is shown to a focus group of patients who are native speakers of the target language: The overarching aim is to see whether the patients understand the text well enough for the purposes of a clinical study. Some companies opt for a clinician review only instead of pairing it with cognitive debriefing. Any feedback given or concerns raised during this review stage – be that by a clinician, patient or both – are incorporated into the text by a qualified translator.
The final step concerns certification, which confirms the quality and accuracy of the text to regulatory bodies. Certification issued from First Edition Translations is built on our status as a Corporate Member of the Institute of Translation and Interpreting, as well as our own certifications to the international standards ISO 17100 for professional translation services and ISO 9001 for quality management.
The role of linguistic validation
Laying the foundation for a successful launch of global research, Linguistic Validation forms a key part of diverse and inclusive trials, supports healthcare decision-making, and helps to streamline national agency authorisations. Communication in clinical trials has a direct impact on patient safety, which is why it is crucial to get it right in every single language. The impact of miscommunication can be far-reaching. Besides affecting the safety of trial subjects, any concerns raised with regard to the accuracy of patient-facing materials can cast doubt on the validity of the trial results and ultimately impact on the regulatory approval process. Linguistic Validation, with its multiple rounds of quality assurance and conclusive certification, safeguards against any disconnect in communication between patients and the trial sponsor team.
Working with the right people
First Edition Translations collaborates with CROs, pharmaceutical manufacturers, university hospitals, and MedComms agencies across the globe. Within our ISO-certified framework, our multilingual project managers work alongside our specialised life sciences translators and linguistic validation consultants to ensure optimal quality across the board. We’ve been in the business since the dawn of the 80s – and for good reason. Whatever the size of your project and whatever languages you require, we are happy to discuss your needs under enquiries@firstedit.co.uk