Ensuring Accuracy in Clinical Trial Translation

MLH has a well-established history of providing diverse translation and language services to University College London (UCL). This case study highlights MLH’s specialised expertise within the medical sector, specifically its support for the MRC Clinical Trials Unit (MRC CTU) at the UCL Institute of Clinical Trials & Methodology. The MRC CTU is a leading institution focused on addressing critical international health challenges, particularly in infectious diseases and cancer. Their work involves complex and innovative clinical trials, necessitating meticulous attention to detail and precise communication across various linguistic landscapes.

The MRC CTU conducts groundbreaking clinical trials that often involve international collaborations and multi-lingual patient populations. This necessitates the translation of highly technical and sensitive medical documents.
In this specific instance, the MRC CTU at UCL approached MLH for a critical project: the back translation of a clinical trial form from Spanish back into English. The project centred around the EHVA T01 (European HIV Vaccine Alliance Therapeutic Trial 01). The EHVA project had initiated a clinical trial to evaluate a candidate therapeutic HIV vaccine and immunotherapy medicine. The subject matter and terminology were exceptionally specialized, requiring a very high level of accuracy. The challenge for MLH was to ensure that the back-translated document retained the original meaning and nuance of the source English document, while accurately reflecting the Spanish translation. This was crucial for maintaining the integrity of the clinical trial data and ensuring regulatory compliance.

Specialised Translator Team: MLH assembled a dedicated team of translators with expertise in both Spanish and English, and, crucially, a deep understanding of medical terminology related to HIV vaccine trials and immunotherapy. This included translators with backgrounds in:

• Immunology
• Virology
• Clinical trial protocols
• Pharmaceutical terminology

Back-Translation Methodology: MLH implemented a rigorous back-translation process:

1. Assessing the Translation: MLH assessed the material already translated into Spanish by a qualified translator.
2. Back-Translation: The Spanish translation was then translated back into English by a qualified translator, who had not seen the original English document.
3. Reconciliation: A third, senior linguist with expertise in medical back-translation compared the back-translated English document with the original English document. This involved:

• Identifying any discrepancies in meaning, terminology, or nuance.
• Analysing the reasons for these discrepancies (e.g., linguistic ambiguity, cultural differences, terminology variations).
• Recommending revisions to the Spanish translation to ensure accuracy and equivalence.

4. Terminology Management: MLH created a project-specific glossary of key terms related to the EHVA T01 trial. This glossary ensured consistency and accuracy in both the initial translation and the back-translation.
5. Quality Assurance: The entire process was overseen by a dedicated project manager who ensured adherence to timelines, quality standards, and client communication.

Confidentiality and Data Security: MLH adhered to strict confidentiality protocols to protect the sensitive information contained in the clinical trial documents. This included secure file transfer, non-disclosure agreements, and restricted access to project files.

MLH devised a solution tailored to the specific demands of this back-translation project:

The project was a resounding success. MLH delivered a back-translated clinical trial form that met the highest standards of accuracy and linguistic equivalence. The MRC CTU was highly satisfied with MLH’s professionalism, expertise, and commitment to quality. The accurate translation ensured the integrity of the clinical trial data, facilitated seamless communication among international research teams, and supported compliance with regulatory requirements.

This case study demonstrates MLH’s exceptional ability to handle the complexities of medical translation, ensuring accuracy, regulatory compliance, and cultural sensitivity. By providing tailored language solutions and employing rigorous quality assurance processes, MLH enables organizations like the MRC CTU to conduct critical research and achieve their global objectives.

Contact MLH today to learn how we can help you bridge communication gaps and achieve success in international markets.