Clinical research is undergoing the same globalization process as other industries. Pharmaceutical companies are increasingly shifting clinical trials to emerging markets. Some of the factors influencing the shift in location include: Substantial cost savings; shortened timeline for clinical testing; and regulatory barriers for drug approval in the U.S.

As the number of clinical trials continues to grow outside of the U.S., instruments used to gather data directly from the patients, or Patient-Reported Outcomes (PROs), must be translated into the patient's language. However, once the English version is translated into another language, the possibility of inconsistencies arises. This is particularly true when there are a number of different languages across the trial sites and trial countries.

The impact of language and culture on Patient-Reported Outcomes
Each stage of the drug's life cycle is touched by language and culture. Cultural practices and values can affect substantially a therapy's successful development and market adoption, influencing everything from disease diagnoses to a patient's definition of life. For example, in some Latin American cultures simpatía is an important word and cultural value. Translated as "congeniality" or "affection," the level of simpatía that patients perceive in the clinical setting influences how satisfied they feel with their care, potentially influencing their willingness to disclose their complete patient history, to adhere to treatment, or report adverse events.

In order for an instrument to be used in international studies, it must address the same concepts in all languages in order to make it possible to pool data and compare results across countries. This is done through a series of steps involving multiple teams of translators, as well as focus groups for accuracy across languages, dialects, and cultures.

Translation and validation
PROs translation follows a very rigorous process. There is no one ‘correct' methodology, but there are various industry organizations that evaluate the translation components for PROs. Most involve more than one forward translation. These translations are then reconciled into a single forward translation using the best components of each. This is done by a team of native language speakers. Another team completes a back translation into English, which is then compared to the original source file. Based on these findings mistakes or ambiguities are corrected. Then, the single language file is culturally adapted into the local dialects.

With so many linguistic differences and cultural nuances – even within the same trial country – it is crucial to validate trial documents for linguistic and cultural accuracy.

To test the translation, or validate the accuracy of an instrument, Global Language Solutions performs cognitive debriefing or pilot testing of the translation on a small group of individuals who are the native speakers of the target language. The focus group, which is run by a moderator, should consist of people across diverse economic, education, and demographics to make up a general population for the testing.

By conducting focus groups, you can uncover areas of cognitive difficulties, grammatical mistakes, or culturally inappropriate statements. For example, US-based education system levels, such as high school, do not translate across to countries with different education classifications. Not only will you achieve an accurate translation of the English scale, but it is also relevant to the cultural and economic structures of the local environment; leading to greater compliance by the patient, and better quality of information recorded by the patient during the trial.

Find out more
Global Language Solutions (GLS) provides professional translation and cross-cultural adaptation of PROs into 100+ languages. Contact us for more information. For additional information about the clinical research industry, visit this issue's Useful Links or Upcoming Events.

Sources:
"Ethical and Scientific Implications of the Globalization of Clinical Research," The New England Journal of Medicine. February 19, 2009.