The Role Of Translation In Clinical Trials

Over the past decade, clinical trials for new drugs, treatments and medical devices have been increasingly conducted in emerging markets such as, Latin America and India. These regions and countries offer a number of attractive benefits to clinical trial sponsors such as lower costs, easier recruitment and a quicker study completion. The market’s requirement for professional human medical translation services has in turn grown as more clinical trials take place overseas. Money spent on clinical research is a significant percentage of the total cost of introducing a new drug to the market and therefore reducing clinical research costs is extremely important. However, just as important as the chosen destination for conducting the clinical trial is the quality of the translation. An inaccurate and low-quality translation during the trial period can lead to even more significant costs and put the new drug, treatment or medical device at risk.

Regulation Of Clinical Trial Translations

A high quality translation for clinical research is a regulatory issue as it needs to accurately translate the data in order to comply with a number of rules set by a diverse range of organizations. The European Union, local governments, the World Health Organization and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)  are just some of the entities which need to be taken into account to ensure that the trial data is accurate and meets their individual rules and regulations. Each organization and body has their own regulations related to ethical standards and how clinical trial research should be conducted and in turn translated.

Ethical Side Of Clinical Trial Translations

The year 2014 marked the turning point across the world as new medical regulations were introduced to protect clinical trial patients in the European Union and in the popular research destinations in Latin America, China and India. As well as adhering to these new regulations it is a fundamental right of clinical research patients to be provided with informed consent forms that have been accurately translated and localized for the target audience so that they can be easily understood. The localization and quality of the translation is particularly important when considering that a minor change in the context or wording may lead to confusion especially with the amount of medical terminology used. Having a professional translator who also has medical industry experience is essential to be able to outline medical terminology in a way that is not overly technical for the patient to understand.

Accuracy Of Clinical Research Translations

Translation plays a key role in a company’s clinical research even before the actual study takes place. The translated marketing materials used, need to resonate with the brand’s image and messaging as well as the target audience which can only be achieved with localization services. Once the trial has been conducted, the careful translation of the results from one or more source languages into the sponsor’s target language needs to take place. This particular task requires quality assurances during the translation process as incorrect study conclusions on the safety and effectiveness of the drug, treatment or medical device can have a significant human cost once it has become available to the market. While the English language remains the most popular language for clinical research publications, translating the final draft of the clinical findings is just as important so that scientists around the world are able to read the results and develop on this new research.

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