The globalization of clinical trials is no longer a matter of speculation, it is a reality. Trials to continue to shift towards emerging markets such as China, Russia, and India in the search for more patients, lower costs, and faster recruitment. In 2005 as much as 40% of all drug trials conducted were in emerging markets, up from about 10% in 1999. Each state of a drug’s life cycle is touched by language and culture. Here are three tips for conducting clinical research in multiple languages.
- Consider the unique role culture plays. By understanding differences in culture, meaningful communication can be established with patients, physicians, project teams, and other stakeholders. It is important to consider that doctors, patients, and vendors may respond differently to levels of formality and may have different priorities or concerns. In addition, certain topics may be socially or culturally inappropriate for direct questioning techniques and investigation. It is important for those designing trials, administering training, and providing linguistic/cultural support to consider potential problem areas prior to executing a trial and executing within a clinical trial management system.
- Plan ahead for possible language misunderstandings. Some sponsors believe there is no need to worry about language barriers because most require English fluency in their clinical development team. However, it is important to consider that most people using English professionally are not native speakers. Sponsors should expect language related misunderstandings during the planning of a multi-national clinical trial and prepare for them. Through the emerging mobile health field, there may be a solution to language related problems using a clinical trial management system. It is now very simple to translate consent documents and run a trial remotely through a mobile app in the user’s native language.
- Accurate translation is key. When handling language-related issues (i.e. consent documents) accurate and reliable translation is essential. Training materials and forms should be prepared in local languages, and a simplified version of English is recommended for international meetings and correspondence. It is important to also choose translators who are technically fluent in the terminology of the relevant medical field. A misunderstanding in dosage or information on the consent form could be very dangerous to both the patient and trail sponsors.
Parallel 6 has developed a clinical trial management system, Clinical Reach, which creates opportunities for remote clinical trials. The platform can be customized to fit language and cultural differences, including translating eConsent documents. To learn more about Clinical Reach, visit Parallel 6’s website and request a demo.