The Features of Clinical Trials Translation

Foreign companies have a constant need to translate the accompanying documentation to Russian at the stage of preparation of materials and when receiving the results of medical research. The same need arises in Russian medical institutions. The growth of demand for such translations in a particular segment is connected with advent of technical inventions and active development of the pharmaceutical industry.

When translation of research documentation is required?

The process of translation of large-scale medical trials isn’t like other versions of exposition of a foreign text. The terms used for translation of such standardized documentation as instructions for operation of computer equipment are widespread and don’t require significant clarification. As for medical trials, in this field not just the original terms are used. Each type of research is characterized by a special language and specific terminology.

Most often, clinical trials are scientific works of international level, so more than 80% of documentation is compiled in English. At the same time, there is always a need to translate all received materials to a native language of the target group participating in the study. It happens that in the process of the documentation studying, it’s necessary to have it translated back to a source language for a more detailed collection and study of provided information. This situation is possible, for example, when analyzing personal diaries of patients and other non-public research materials.

What services does a translation agency offer?

Clinical research translation services usually work with the following documentation:

• basic legislative documents on relevant medical practice;
• materials on GMP, GLP, GCP;
• medical trial protocols of medicines;
• individual registration cards for medical trials of medicinal products;
• documents containing information of side effects, interruption and completion of the medical research;
• reports containing analysis of information obtained during the research.

Difficulties in translation of clinical trials

If a trial will involve patients from different countries, then the relevant materials are translated to a language that is understandable to them and, at the same time, reflecting the specifics of a research. Therefore translators shouldn’t just be specialists who are fluent in a foreign language, but also have a medical education. They will make translation available to patients — on the one hand, and on the other hand — professionally reflecting the results.

To be sure that all specific terms have been translated correctly, a special terminological dictionary should be compiled. Translation services include the formation of a vocabulary in the composition of works. A medical organization or research group only makes changes or approves a medical terminology in dictionary proposed by an agency. Also, there are options when a client provides a glossary for work.

Translation of clinical documents obliges to know the specifics of the language of medicine and pharmaceutics, since erroneous or inaccurate pharmaceutical translation can lead to unpleasant consequences. The worst of them is when a patient has a negative side symptom during treatment.

Another problem is delay in deadlines. If launch of development of a drug stalled due to difficulties in translation or its poor quality, the results for a pharmaceutical company will be deplorable. Creation of a drug in a laboratory and its withdrawal to the pharmaceutical market costs several hundred million dollars. Any delay can result in the loss of a multimillion-dollar income, or the loss of the need for this tool, due to more agile competitors showing up.

Another threat is incorrect translation of the patient’s results, as well as information obtained from their personal diaries. Future of a drug largely depends on accuracy of understanding the questions posed to patients and the answers received from them.

To be sure of quality of translation, it’s worth to turn to services that specialize in medical translation and have solid work experience.

Kevin Lechner, Belgium

I sent a big term paper and did not expect such a quick reply with the ready term paper in Russian!

Laura Butler, Ireland

RTS was helpful when I almost lost a hope to get a visa. Simultaneously, the price-list is enough democratic one!