Publications

Communications Crossroads

(International Clinical Trials February 2012)

Language Barriers in Global Trials

(ACRP: The Monitor August 2011, Special Issue: Challenging Issues in Clinical Trials)

Overcoming linguistic and cultural barriers is one of the biggest challenges in outsourcing clinical trials to emerging regions. As the number of global trials continues to increase, there is a greater need to adequately address these issues. Translation of clinical trial documents requires a high level of accuracy and demands an understanding of cultural elements. Quality and cultural context are especially important in the preparation of patient-related materials, where not only the accuracy of the text being translated, but how a message is conveyed, is of critical importance.

Clinical Trials in Emerging Latin American Countries

(DIA Global Forum August 2011)

As the number of outsourced clinical trials continues to increase in emerging Latin American countries, particularly Peru, Chile, and Colombia, sponsors must address significant challenges. Despite the single translation requirement, there are variations of Spanish as well as regional dialects in each country that must be considered, especially when translating patient materials such as informed consent. Cultural differences and socio-economic factors that interfere with informed consent must also be taken into account. If these barriers are properly addressed, not only will patient be better protected, but the quality of clinical trials and healthcare will ultimately be improved in the region.

China’s Clinical Trial Boom: A look at linguistic and cultural challenges

(PharmaFocus Asia Issue 14, 2011)

Due to unprecedented economic growth and increased healthcare expenditures, experts predict that China is positioning itself to become the world’s fourth largest pharmaceutical market by 2012. In addition to increased production and distribution by foreign pharmaceuticals, the clinical research sector has experienced significant growth, making China one of the region’s primary locations for outsourcing clinical trials. However, several challenges remain for foreign sponsors, including regulatory hurdles as well as significant linguistic and cultural barriers. Despite a single translation requirement, translation of clinical trial documents into Mandarin Chinese requires great expertise and knowledge of the structural, grammatical, and cultural differences between Mandarin Chinese and English or Western European languages.

Language and Culture in Global Clinical Trails

(Applied Clinical Trials June 2011)

As clinical research expands into emerging regions, meeting specific regulatory requirements in each country and addressing the vast linguistic and cultural differences among different patient populations are some of the biggest challenges sponsors must face. In order to avoid problems with ethics committees as well as ensure accuracy of study results, regulatory documents must undergo an especially rigorous translation process, and patient-related information especially must be culturally adapted. In addition, cultural factors that interfere with patient reporting or access to health care must be addressed.

Turkish Delight - Translating Turkish Clinical Trials

(International Clinica Trials February 2011 )

Clinical research is expanding into new emerging countries, including Turkey. There are numerous advantages to outsourcing clinical trials to Turkey, especially as regulatory standards and procedures are improving. However, the translation of regulatory documents and patient information presents its own challenges, as specific linguistic and cultural differences between Turkish and other western languages must be addressed. In addition, cultural barriers to research must be considered, including cultural perceptions regarding disease and symptoms.

Linguistic & Cultural Considerations: Outsourcing Trials to Asia

(Scrip Clinical Research February 2011)

Clinical trials are moving to emerging markets in Asia in part due to the growing demand for larger and more diverse subject pools, and the increase in multiple trials. Several Asian countries have become prominent outsourcing locations for clinical research. Although there are several advantages, the great linguistic and cultural diversity, often within the same country, creates significant barriers. Overcoming these barriers by employing experts is essential for the success of clinical research. Limited health care access and disparity among certain populations make it especially challenging to maintain ethical standards in some countries.

Today’s Russian Clinical Trial Environment

(International Journal of Clinical Practice July 2010)

Due to the escalating costs of bringing a drug to market, many pharmaceutical and biotech companies are outsourcing clinical research to emerging regions. One emerging country in particular that has expanded its clinical research sector is Russia.

Addressing issues affecting clinical trials in Brazil

(Informa Healthcare Clinical & Regulatory Affairs May 2010)

Brazil has a very large, racially & ethnically diverse population, with a great disparity in education in economic status. Although Brazilian Portuguese is the only translation requirement for regulatory documents, however, there are language and cultural barriers that must be considered. Accurate, quality translation and cultural context are both critical factors. Cultural attitudes that affect medical practices are also key factors.

Korea Path

(International Clinical Trials May 2010)

South Korea is quickly becoming a dominant outsourcing clinical trials location in Asia, the regulatory environment has undergone dramatic changes within a short time to keep up with demands, language and cultural barriers are a major issue despite the single translation requirement, cultural factors that affect medical practices and the use of traditional medicines and therapies must be considered.

India’s Future as a Biologics Manufacturing Hub

(BioPharm International. March 2010.)

Indian biotech rapidly growing, offshoring trends are directed toward greater collaboration between Western and Indian companies to help overcome difficulties associated with biologics production, in addition to regulatory issues, overcoming language and cultural barriers is key, regional differences, lower cost of India’s biologics manufacturing may allow more products to be available for less.

(Applied Clinical Trials November 2009)

Two things distinguish South Africa from other countries in Africa: South Africa is the most economically developed African country and it has established better regulatory standards for conducting clinical trials. In addition, several factors are responsible for the growth of clinical research including a large, diverse patient population that for the most part has not undergone previous treatment, and lower costs for clinical research. However, in order to ensure that international ethical standards are maintained, sponsors must be aware of the country's patient demographics, including the numerous languages and cultures native to different South African populations. Poverty and illiteracy must also be addressed in the context of informed consent procedures. These issues should be addressed by companies outsourcing clinical trials in the region.

Conducting Clinical Trials in India

(DIA Forum August 2009)

Over the next couple of years it is expected that India will become an important location for outsourcing clinical trials. Several factors are responsible for this predicted growth including India's large, diverse patient population, reduced cost in comparison with the West, and high English proficiency among clinical investigators. However, there are several factors such as poverty, illiteracy, and language and cultural barriers that must be taken into consideration. India is a very diverse country with vast cultural and linguistic regional differences. In addition, regulatory approval differs from state to state, despite attempts at centralizing the system. These issues must be addressed in order to successfully conduct clinical research in the country.

(Applied Clinical Trials June 2009)

Latin America is emerging as a dominant clinical trial location due to various factors including successful recruitment rates and a single language translation requirement throughout most of the region facilitating multinational trials. However, successful clinical trial management requires that linguistic and cultural differences among Latin American countries and regional differences within each country be taken into consideration.

(The Monitor ACRP April 2009)

China offers several advantages in biopharmaceutical offshoring including a highly skilled workforce, ultra-modern facilities, substantial government investment in the biotech sector, and significantly reduced labor and manufacturing costs. However, many Western companies maintain that the risks do not outweigh the cost benefits, and problems with quality control and counterfeiting continue to plague China’s biomanufacturing industry.

(PharmaVoice March 2009)

Enormous language, cultural, political, and socioeconomic differences exist in many of the countries that are becoming primary outsourcing locations for clinical research. These create significant barriers to patient recruitment, especially in obtaining informed consent. In addition, regulatory approval processes and timelines in each country vary considerably. Accessing this knowledge and addressing the differences in each country, therefore, are some of the greatest challenges companies face in recruiting for global clinical trials.

(GCPj February 2009)

Among countries in Latin America, Mexico has become a prominent clinical trials location. There are many reasons for this, including high patient recruitment rates and geographic proximity to Western companies. Among influencing factors, however, regional differences in spoken Spanish as well as cultural perceptions that affect clinical research are important considerations.

(Journal of Best Clinical Practices December 2008)

Translating an informed consent form (ICF) from American English into Spanish requires awareness of the particular version of Spanish spoken by the target population. Even within the same country, there are often regional linguistic differences that must be taken into account. A comparison of commonly used clinical trial terms reveals that not only are there important differences between Latin American and European Spanish, but there are several differences and translational requirements in Spain alone.

(GCPj November 2008)

Despite the importance of testing new biopharmaceutical products for safety and efficacy in all populations, ethnic and racial minorities continue to be under-represented in U.S. clinical trials. As U.S. minority populations are on the rise, their inadequate participation is becoming a concern. Several factors are responsible for this, among which language barriers and cultural attitudes play a major role.

(The Monitor ACRP October 2008)

One of the newly emerging regions for conducting international clinical trials is Central and Eastern Europe (CEE). Many factors have facilitated growth in clinical research in this region, including successful recruitment rates and a reputation for conducting high quality clinical research. However, the diversity of languages and cultures among CEE countries pose linguistic and cultural barriers that must be overcome.

(Scrip August 2008)

Given the greater demand for high-quality, low-cost biopharmaceutical manufacturing, offshoring is occurring farther from the United States and Western Europe. There are several prominent biopharmaceutical offshoring locations in Asia, among which. India and China are currently the most dominant. However, global offshoring of biopharmaceuticals introduces many new variables.

(DIA Forum August 2008)

As the demand for larger patient pools grows, countries with less experience are quickly emerging as clinical trial sites. The most prominent emerging regions include CEE, Latin America, and Asia. This globalization trend is introducing new challenges in conducting clinical research, including language and cultural barriers.