Conducting multi-site or international clinical trials may help pharmaceutical companies and investigators increase a study’s pool of patients as well as include data from different ethnicities and backgrounds. However, language and communication can prove to be major obstacles that need to be overcome in the clinical trial process, since researchers not only need to exchange understandable information with study participants in different countries, but also need to comply with rules from the American public health authorities, such as the U.S. Food and Drug Administration (FDA).

Because accuracy in the research and development process is key to achieving successful results, translation of information from American drug development companies for foreign study participants, as well as documentation, must be a priority for any clinical trial with an international scope. Communication is mainly conducted between physicians and patients at trial test centers, making it crucial that both doctors/investigators and the study participants understand forms, disease concepts, side-effects and outcomes.

The clinical trial translation process always depends on external factors, including patients’ literacy, available information, and materials or cultural considerations, but translation into foreign languages may be the most important of all these considerations, since the quality of translated documents can determine the accuracy of results and the approval or denial of the study’s results. More.

See: BioNews Texas

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