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Conducting Clinical Trials in Latin America

In today’s competitive landscape speed is key in getting a drug from discovery through to market. Everything that speeds up the clinical trials process (without sacrificing safety and quality) is a priority to today’s drug developers because it is essential in shortening a product’s time to market. Clinical trials across multiple regions of the world have become common practice, with the goal of bringing new drugs and devices to patients around the world, as fast as scientifically possible.

Conducting clinical trials in Latin America provides sponsors large patient populations within a condensed geographical area. For example, more than 626 million people live in Latin America, with 70% of the population concentrated in urban areas like Buenos Aires, Mexico City, Sao Paulo and Rio de Janeiro.  Additionally, the commercial markets are attractive due to relatively lower cost for greater speed.

Latin America offers patients in medical centers with competent and qualified investigators and established regulatory systems at comparable cost. There are challenges, however, that require forward thinking and strategic planning to optimize timely study start and execution.

Selecting an Outsourcing Partner

One of the most important decisions a sponsor makes is choosing the right outsourcing partner to execute a successful clinical trial program in Latin America. Clinical trials conducted by a Contract Research Organization (CRO) may be completed more quickly than those conducted in-house by pharmaceutical companies, and there are some very compelling reasons for that.

A CRO with representation within the country will possess the expertise to navigate the waters of regulatory submission requirements within each given country, and lack of regulatory harmonization makes it challenging for the novice.  Approval times vary widely and omission of required documents will delay review.

Furthermore, challenges to be expected and managed include status of Intellectual Property protection from country to country, cultural and medical differences, logistical challenges around drug storage depots, patient biologic sample handling, regulatory challenges associate with adaptive trail design, ethic review process and more.  Site feasibility alone must consider public perception and work to dispel misconceptions in multinational trials and identify and train sites of excellence, both in the private sector and in large metropolitan facilities.

An outsourcing partner must understand issues that affect the conduct of clinical trials unique to each country within Latin America, and be versed at accessing patients. They must have a representative that is a source of local culture, to provide insight to accommodate the diversity that exists within a given region in a country, and to address the challenges and concerns that arise.

Translation and Language Barriers

In addition to outsourcing the study execution, there is a translation component—working with a language services company who not only specializes in local languages and regional variations, but also translation of clinical research and regulatory documents. Only in some countries, the investigator´s brochure and a few other documents can be submitted in English, but these are rare exceptions. It is important to note that even though Spanish is spoken in most countries, except for Brazil, the meaning of certain words and phrases varies between countries.

Addressing language barriers therefore requires an understanding of the patient demographics in each country. Although all regulatory documents must be provided the official and written language of the country, any patient-related materials must be adapted for the target patient population. For example, the people of Peru predominantly speak three different languages: Spanish, Quechua and Aymara. In Colombia there are about 65 indigenous languages and nearly 300 dialects. Colombian Spanish is a mixture of the Caribbean dialect and Peruvian coastal dialect.

Dominant indigenous populations not only influence the way the language is spoken in each of these countries, but they are also responsible for differences in the local culture. Among the most common reasons for delays by ethics committees are problems with informed consent, and these are often associated with poor quality translation. In large part, this can be avoided if linguistic and cultural differences are properly addressed. Experts who are native speakers and have a background in clinical research are best equipped to perform such culturally sensitive translations.

Find Out More

In our next issue of Global Communicator, we expand on the topic of overcoming outsourcing challenges and working with qualified partners in all stages of the process. Sign up to subscribe to our monthly newsletter for more articles and resources specific to global life sciences companies.

For information on how Welocalize Life Sciences can accurately and efficiently translate and localize clinical research trial documents for Latin American countries, contact us.

For more information on conducting clinical trials in Latin America, consider these research-based papers and reports:

Cancer Clinical Research in Latin America

Doing Clinical Research in South America

Latin American Contract Research Organization Market

Why Racial Diversity in Clinical Trials Matters

Clinical trials provide a critical base of evidence for evaluating whether a medical product is effective before the product is approved for marketing. One challenge that remains is ensuring that research participants are representative of the patients who will use the medical product.In 2014, the Federal Drug Administration (FDA) released a report that called for, among other things, “identifying barriers to subgroup enrollment in clinical trials and employing strategies to encourage greater participation,” that was specifically aimed at underrepresented ethnic populations and women. Historically, the elderly, women (in some therapeutic areas), and racial/ethnic minorities have been underrepresented in trials. In response to these concerns, Congress included Section 907 in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, giving FDA direction to evaluate this issue and take action.An infographic published by Continuum Clinical shows examples of the massive health disparities among common disease states across different races and genders.
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According to the FDA, African Americans comprise 14% of the U.S. population, but only 5% of clinical trial participants. As the infographic above illustrates, African Americans account for a disproportionately high number of cases of cardiovascular disease and hypertension. Similarly, Hispanic/Latinos comprise 17% of the U.S. population, but less than 1% of clinical trial participants. Yet diseases such as obesity and Type 2 diabetes disproportionately affect Hispanic populations.Racial diversity in clinical studies matters because patients may respond differently to therapies based on their ethnicity or gender.For example, studies for a recently approved schizophrenia drug found that two important classes of blood pressure drugs were found to work less well in black/African American patients. The FDA has also reported labeling changes due to differences in dosing requirements between men and women, such as the recent labeling change with a sleep medication. As the  FDA’s Commissioner of Food and Drugs, Robert Cliff, stated in early 2016 when the FDA declared 2016 as the year of diversity in clinical trials, “These few examples show the importance of improving diversity in clinical trials, so medical products are safe and effective for everyone.”Welocalize Life Sciences specializes in linguistically and culturally accurate translation services for life sciences companies. Contact us for more information about our services for highly regulated industries.