Virtually half of the clinical trials in life sciences today take place outside of the US, and a majority of trials regulated by the US Food and Drug Administration (FDA) are held abroad—mostly in developing countries.
One big reason for outsourcing clinical trials to developing countries is that it can save pharmaceutical companies as much as 90% on the cost of clinical staff at the testing facilities. Another important reason for outsourcing is to ensure that drugs are effective across different ethnic groups. The greater the diversity of the testing subjects, the more reliable the results will be for companies seeking to market their products to different populations across the world.
Testing pharmaceuticals on human subjects always requires great care and precision. When these tests are held in foreign countries with diverse languages and cultures, an entirely new set of challenges will arise for the study sponsor: All vital documents will require translation—either via a medical translator or a medical translation service.
Accuracy is critical
All of the collected information, including recruitment materials, informed consent forms, patient questionnaires, and case report forms must be translated into the local language and the results translated back into English to allow researchers to analyze the information.
This kind of translation leaves no room for error. If the forms are mistranslated, thousands of patient results could contain incorrect data. Regulatory submissions could become compromised, delaying review and approval. Every effort must be made to ensure error-free deliverables in order to maintain the integrity of the study.
Potential challenges
Two of the main translation challenges that arise when a test subject speaks a different language from the researcher are:
- Gaining conceptual equivalence — Infusing cultural meaning into translations. It’s not enough to simply understand the test subject’s language; a familiarity with their culture is necessary to convey the connotations behind specific words and phrases. This is particularly important when it comes to patient diaries, questionnaires, and other materials where understanding the cultural context of what the subject is saying is of utmost importance.
- Expressing intention — It’s vital to ensure that translations reflect what the subject intended to express. When a translation is too literal, it risks leaving out some of the intended meaning.
Industry guidelines
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) has released two reports on best practices for translations of:
Both reports address ways to improve translations and cultural adaptations in clinical trials. One key finding was the need for a separate process for medical translation from one language to another, versus same-language translations such as converting Spanish spoken in Spain to Spanish spoken in Argentina.
LSP assistance
Moving clinical trials overseas has helped pharmaceutical companies save money, increase diversity amongst research participants, and open new markets for industry products. The process, however, has placed translations in the spotlight. Using a professional medical translation service can remove the related stress by ensuring 100% accurate translations of clinical trials – no matter where they take place or in what language.