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.
Pharmaceutical companies and clinical research organizations (CRO) that perform clinical studies outside the United States need to meet the requirements of the World Medical Association’s Declaration of Helsinki, which requires researchers to provide information to study participants in a language understood by them, either orally or in writing. As a result, when conducting international studies, pharmaceutical companies as well as CROs need to translate a broad range of documents, including Case Study Report Forms, Clinical Study Protocols, Clinical Study Report Forms, Informed Consents, Patient Diaries/Forms/Materials, Preclinical – Phase IV Documentation, and Quality of Life Scales and Questionnaires, from English into all local languages wherever a clinical trial is being held.
The National Institutes of Health (NIH), for instance, requires that all projects supported by the NIH that work with study staff or volunteers whose primary language is not English follow regulatory translation requirements and Good Clinical Practices (GCP) standards, an international ethical and scientific quality standard from the FDA for the design, administration, recording and reporting of clinical trials involving humans.
Principal investigators of research studies are responsible for coordinating the translation and providing the NIH with all the translated documentation, while studies must include clinical staff on the site who are able to communicate in the local language, increasing understanding of procedures.
Given this challenge, some pharmaceutical companies and CROs turn to medical translation services, which are expected to provide more accurate results by working with medical professionals and native speakers of the language. Translation of medical information during clinical studies can be a great concern, which can increase during the process of medical products’ approval.
BioNews Texas recently reported on the challenges associated with receiving the CE Mark in Europe for bioproducts developed by American companies. In order to receive approval by health authorities outside of the United States, companies need to present accurate documentation concerning product safety and effectiveness. There are multiple documents that need to be carefully filed and submitted, some of which require translation into foreign languages.