Due to a number of factors including higher patient recruitment rates, clinical trials are increasingly outsourced to emerging regions – particularly Latin America, Central and Eastern Europe, and Asia. Successful international trial initiation, however, is greatly dependent on choosing the right language service partner to provide quality and accurate translation of global patient recruitment materials.
Global Patient Recruitment Factors
Highly successful global patient recruitment in many emerging countries has fueled a dramatic increase in the globalization of clinical trials. Large, treatment-naive and diverse patient populations play a big role in the higher subject recruitment rates observed particularly in Latin America, Central and Eastern Europe (CEE) and Asia.
But the successful initiation of clinical trials in each region is largely dependent on navigating regulatory differences and the ability to overcome language and cultural barriers. Despite efforts to create a more harmonized regulatory system in each region, as well as align with international ICH-GCP standards, regulatory differences continue to make the process more challenging. Each country has a national regulatory authority, and local Institutional Review Boards (IRBs) and Ethics Committees, with their own set of regulations. Moreover, linguistic and cultural barriers further complicate patient enrollment, particularly in countries with multiple translation requirements, and where cultural and socioeconomic differences interfere with established ethical standards.
Global Patient Recruitment and Informed Consent Translation
As companies gain more experience conducting clinical trials in emerging regions, there is a greater understanding of the important role that translation and cultural adaptation play during global patient recruitment in global clinical trials. Currently most regulatory authorities require translation of informed consent forms (ICFs) and other patient recruitment materials into the patient’s native language by a certified professional translator.
Identifying the native language of the target patient population is one of the most important factors in planning a global trial. It cannot be taken for granted that this means simply translating into the official language of each country. Depending on the country and patient population, the native language may be one of several dominant regional languages. This often means that multilingual versions must be constructed. In some cases, among certain patient populations, verbal consent in the patient’s spoken language is required, with the assistance of a professional medical interpreter.
Translations of patient information must not only be culturally adapted in order to ensure that they are culturally relevant, but factors that influence medical practices must also be taken into account. For example, in many countries it is common practice not to fully disclose a patient’s diagnosis for patients with a fatal disease. Part of the reasoning behind this practice is that it is important for the patient to maintain a positive attitude towards his or her illness. This presents the challenge of protecting patient rights according to international standards, while at the same time respecting the local cultural norms.
The Role of Translation Agencies in Global Patient Recruitment
Ensuring that patient rights are adequately protected during the subject enrollment process requires prior knowledge of a particular country or region. Most foreign companies count on local experts and Contract Research Organizations (CROs) for guidance. Language service providers offer additional support by partnering with local agencies to ensure that linguistic and cultural differences are properly addressed, not only for patients enrolled in a study but also in dealing with local regulatory authorities.
Translation services agencies with experience working in the life science industry in a particular region are best equipped to address any unique language or cultural barriers. Take for example the fact that many patients in emerging regions commonly use traditional medicines while they are participating in a clinical trial. This may interfere with the accuracy of clinical data if it is not included in the patient’s information during enrollment. Translation means taking into account not only vast grammatical and structural linguistic differences, but also the issue of identifying proper language equivalents for terms or phrases which do not have a direct translation. Take the following question: “Are you able to perform normal daily chores …?” A direct translation of the English word “chores” does not exist in many languages, and therefore a translation equivalent such as “daily activities” must be used.
Summary
As reduced subject enrollment rates in the United States and Western Europe become a major limiting factor, outsourcing clinical research to emerging regions such as Latin America, Asia, and Central and Eastern Europe continues to increase. This outsourcing trend has brought with it new challenges, including regulatory differences as well as linguistic and cultural barriers. Successful global patient recruitment, as a result, largely depends on partnering with an experienced language service provider.
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