Clinical Trials Go Global - Next Stop, Latin America

By 2012, more than 65% of FDA-regulated clinical trials for leading pharmaceutical companies will be conducted outside of the United States. Where to conduct clinical trials can depend on many criteria, including the location of corporate global facilities, costs, regulations and future product launches.

More and more, emerging market regions are being considered because they offer significant market potential (pharmaceutical growth in the United States in 2009 is projected to be 4-5% whereas, in emerging market regions, it is projected to be 14-15% for 2009) without compromising the quality of the trials.

Why Latin America

One increasingly important emerging market region is Latin America, which is popular because the region has established regulatory bodies that are tasked with the development and enforcement of guidelines for clinical research, and the formation of ethics committees to make sure patient safety and ethical concerns are top priorities.

Latin America has also proactively developed policies that adhere to the International Conference on Harmonization (ICH) guidelines on Good Clinical Practice (GCP).

Latin America encompasses Mexico, most of Central and South America, Cuba, the Dominican Republic and Puerto Rico. The World Factbook indicates that 569 million people reside in this region.

The population offers good potential trial subjects because large parts of the population have not been exposed to, nor are they currently taking, medications that may interfere with a trial drug; in other words, there is a large population of treatment- or trial-naïve people.

An additional reason why Latin America represents potentially good subject candidates is because "lifestyle" disease profiles increasingly resemble those of the United States and Europe; diseases such as obesity, heart disease and cancer are on the rise.

The Pharmaceutical Market in Latin America

Of the total pharmaceutical market in Latin America, Mexico, Brazil and Argentina (37.4%, 28.4%, 15.3% market share as a percentage of the total pharmaceutical market, respectively) have seen the most clinical trials. These countries have more advanced regulatory guidelines and streamlined trials approval processes.

Their track records of approval times are approximately 4-6 months from the time the final protocol is translated into Spanish and/or Portuguese - a significant improvement on the trial approval time in the United States or Europe (6-12 months). However, although the trial approval timeline may be shorter, the overall drug approval timeline may be longer with Latin American approvals agencies.

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