Culture and language are important considerations in clinical research and have gained new prominence in the context of multi-national trials. Global Language Solutions consulted with the experts at ProPhase, a New York City-based training, research, and development organization, about some of the issues inherent to global trials and how they help their clients to successfully cross cultural and linguistic borders.
Q. As research activities have expanded into emerging regions of the world, the issue of site training and preparation has emerged as a critical component in a study’s outcome. What are the necessary steps for delivering high-quality training on a global basis?
A. The first step in training on a multi-national/multi-regional level is the understanding and comprehension of local concerns and issues that investigators and patients will face. Too often, we see a “one-size-fits-all” approach to training. One example is the assumption that either all investigators have high levels of English fluency – or more commonly that providing minimally translated training materials is sufficient to ensure comprehension. High-quality linguistic translations are essential and are most effective when coupled with careful review and customization of the entire training and certification process. The training and certification process needs to take into account the interaction between cultural factors, symptom expression, and the distinctive nature of CNS trials.
Q. Why is it critical for drug development companies to consider culture when fostering meaningful communication with patients, physicians, project teams, and other stakeholders?
A. Culture, context, and environment have a profound impact on the way illness is perceived, explained, and expressed. Failure to account for these differences in studies often impairs relations between parties. In addition, variability in pharmacokinetic and pharmacodynamic mechanisms as a result of culture, context, and environment increase the risk of side effects and adverse events in some populations. Moreover, channels of communication operate differently according to social and cultural norms within and between populations. For example, good clinical practice topics, such as true and informed consent, and the physician – patient relationship may impact what is or is not possible in a study.
Read more about how ProPhase helps their clients successfully cross cultural and linguistic borders in the June 2011 issue of Global Communicator, a Global Language Solutions publication.
