26 November 2009
Addressing Language Barriers in Russian Clinical Trials
Addressing Language Barriers in Russian Clinical Trials
By Karen Politis Virk,
Director of Biotech and Pharmaceutical Research,
Due to the escalating costs of bringing a drug to market, many pharmaceutical and biotech companies are outsourcing clinical research to emerging regions. Over the past five years, there has been exponential growth of clinical research outsourced to Russia - the number of clinical trials taking place there reportedly doubled between 2000 and 2006, and the number of patients participating in global clinical trials conducted in Russia more than tripled during the same time period. However, successful outsourcing of clinical trials in Russia is largely dependent on overcoming language and cultural barriers.
The continued growth of Russia’s clinical trial industry can be largely attributed to the country’s overall good clinical research environment, particularly within the context of patient recruitment.
Several factors play a role in the successful enrollment of patients for clinical trials in Russia including a centralized healthcare system, highly-specialized medical centers which facilitate the recruitment of patients in a particular treatment area and the population of over 140 million people who are largely treatment-naïve. Russian clinical research is well established in several therapeutic areas including oncology, cardiology, and infectious and respiratory diseases. The majority of Russian clinical trial sites are located in major urban areas, such as Moscow and St. Petersburg, where especially large patient populations reside.
Other factors which facilitate clinical research include an abundance of highly-skilled clinical investigators, reduced clinical research costs compared to the West, and the Russian regulatory system which is evolving despite issues of bureaucracy. In 2001, a Russian translation of the ICH-GCP (Good Clinical Practices) international guidelines for clinical research was implemented in Russia. Perhaps the most notable factor influencing the growth of clinical trials in Russia is its solid reputation for quality clinical research.
Although there are many advantages in outsourcing clinical trials to Russia, overcoming language barriers remains a major challenge for non-Russian biopharmaceutical companies planning to conduct clinical research there. Despite the fact that some investigators may be proficient in English, most patients are not proficient in a major world language other than Russian.
To ensure effective communication, translation of clinical trial documents must be performed by experts in the field of clinical research who are native Russian speakers and have experience dealing with local regulatory authorities. It goes without saying that adding to this list of requirements is the fact that this qualified expert must also be able to read, understand, and accurately translate from the source language of the documents.
In Russia and elsewhere, professional translators must also routinely perform back translations to ensure that the language used in the original document has been accurately translated into the target language. Finally, documents must be reviewed by a separate group of qualified editors to further ensure accuracy.
While there are translation challenges to overcome, language issues can actually be less complicated in Russia than in many other countries. As is the case in all global clinical trials, documentation must be provided in the host county’s native language(s). In Russia, Russian is the only official native language.
In addition to the official Russian language, there are a number of other minority languages spoken throughout the country. However, most speakers of these languages are bilingual in the minority language and Russian. This means that international sponsors must provide all regulatory documents solely in Russian, in contrast to most of the countries of Central and Eastern Europe where multilingual translations are often a requirement. A single unifying language helps reduce the time and cost of translation to some extent.
Cultural factors which affect medical practices must also be taken into consideration. For example, because patients hold their physicians in high regard in Russia, the decision to participate in clinical trials is largely a result of the physician’s recommendation to do so. Although this greatly facilitates patient enrollment and compliance, some cultural differences can present challenges.
Cancer patients, for example, are often unaware of their disease status since physicians commonly inform only the patient’s family members of the patient’s full diagnosis. The main reason for this is because of the cultural belief that such knowledge may interfere with the patient's treatment.
Such partial disclosure practices must be addressed in how they affect the informed consent process. Therefore, in addition to overcoming language barriers, basic knowledge of cultural differences is important. As with all global clinical trials, patient-related information must be culturally-adapted for the Russian patient population for which it is intended.
Russia and Successful Clinical Trials
As the biopharmaceutical industry increasingly expands into emerging regions, current trends in the growth of Russia’s clinical research sector are expected to continue. Russia’s reputation for quality research, along with excellent patient enrollment, reduced costs, and the presence of highly-skilled clinical investigators, provides incentive for sponsors considering outsourcing in the region. Adherence to ICH-GCP guidelines is also a contributing factor. In addition, the single language translation requirement facilitates a more efficient regulatory approval process. The many advantages of conducting clinical research in Russia have positioned the country as a leading clinical trial location.
However, the importance of overcoming language and cultural barriers must not be underestimated. Employing translation experts who can provide high-quality, culturally-adapted translation of regulatory documents is a key factor in the success of clinical trials in the region. Language service providers who are experienced in working with the specific requirements of regulatory documents for Russian clinical trials are the ideal partner for overcoming these barriers, as they are best equipped to provide insight into the translation requirements for regulatory approval. In choosing a provider, companies should seek those who employ professional translators who are native Russian speakers with a background in clinical research.
For international sponsors to be successful in the growing clinical trial market in Russia, implementing such linguistic and localization strategies to overcome barriers is essential.
Language Connections is a multi-lingual translation agency which specializes in legal, pharmaceutical, medical, and technical translations for corporate and government clients. Contact them at the coordinates below.
2001 Beacon Street, Boston, MA 02135
Tel.: (617) 731-3510 Fax: (617) 731-3700