The Basic Why’s of conducting Clinical Trials in Latin America.

The Latin Science Lure:

All the clinical and diverse geographic locations can offer the benefit of high rates of trial enrolment, large treatment-native populations, and relatively low personnel and operational costs, yet also highly qualified scientific investigators. But a surge in interest from CROs in Latin America is indicative of several additional advantages.

According to ESTERN Medical, the company’s President, Dr. Jorge Estrella MD, has said efforts to focus on Latin America come in response to ‘an increasing amount of interest from our sponsors to conduct trials in this part of the world’. Tasks such as regulatory submissions, patient recruitment and all aspects of clinical trials are being outsourced at an increasingly rapid rate to large US and European headquartered CROs operating in the region as well as a growing band of home-grown CROs.

A Broad Ethnic Diversity:

A strong enrolment rates from the region's large treatment-naïve populations, low costs, and high scientific standards, CRO operations in Latin America offer drug developers the advantages of particularly high patient compliance rates in clinical trials, and probably one of the most diverse gene pools in the world.

Latin America has some of the most ethnically diverse populations of any emerging market region.

A large Hispanic populations, Latin American countries have diverse European, Oriental, Arabic and African population. Access to such a wide variety of ethnic groups for clinical trials is becoming an increasingly important requirement for drug developers due to the trend towards personalized biologic medicines.

Enrolment of large numbers of ethnically diverse clinical trial candidates in one regional location can help to significantly reduce development times and slash costs further. The inclusion of large numbers of Hispanic patients in clinical trials is also particularly favored by US Food and Drug Administration (FDA) & European Agency (EMEA) regulators, as they represent 12% of the US population and the largest ethnic minority in the country. The region, which has a total population of more than 560 million, has some of the largest urban centers in the world. Large cities such as Mexico City, Sao Paulo, Bogota, Santiago and Buenos Aires provide amongst most favorable environments for patient enrolment and general clinical trial logistics.

Experience in Global Clinical Trials:

Stronger and better-established regulatory provisions represent another area where Latin America has an edge over other low-cost clinical trial locations such as India, China and Eastern Europe. Adherence to international standards of Good Clinical Practice (GCP) is generally much higher in Latin American countries than it is in other emerging markets. This is largely because of a longer history of CRO activity in Latin America.

While the presence of CROs in countries such as Mexico, Colombia, Chile and Argentina began in the mid 1990’s, China only introduced GCP rules in 2003, stipulating for the first time that CROs could undertake clinical trials on behalf of clients. In India meanwhile, Amendments made in 2002 to Schedule Y of the 1945 Drugs and Cosmetics Rules properly clarified the environment for clinical research in the country for the first time by allowing firms to undertake clinical trials in India and overseas simultaneously.

So although regulatory improvements have begun in China and India, legislative frameworks are more extensive and regulations are much better understood in the major Latin American countries - notably in Mexico, Chile, Colombia and Argentina. As a result, implementation of the rules is much more effective. CROs and their clients can therefore operate in fairly uncomplicated regulatory environments that require the same safety, quality and ethical standards as those demanded by regulatory agencies in developed world markets.

As well as better established regulatory processes and more experienced regulators, the longer presence of CRO operations in Latin America’s largest countries also offers the advantage of much more experienced clinical trial investigators as well as better established relationships between CROs, sponsors, healthcare providers and academic institutions.

ESTERN Medical Research Dec-02-2008.

Author: Dr. Jorge Estrella MD., President & Medical Director ESTERN Medical.