Latin America: With the rise of intense global competition, pharmaceutical companies are under increasing pressure to develop and introduce novel therapies as quickly as possible.Â As the speed to market becomes increasingly important, the new drugs entering clinical development are faced with increasing competition for subjects and investigators in the key regions for clinical trials, including the US, Canada and Western Europe.Â To avoid the delays that this competition can create, an increasing amount of clinical trials are now taking place outside of these key regions, at almost double the rate.
According to Moravia, "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."
Why is Latin America becoming a popular place for clinical research?
- Policies: Latin America has proactively developed policies that adhere to the International Conference on Harmonization (ICH) guidelines on Good Clinical Practice (GCP).
- Trial subjects: 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-naÃ¯ve people.
- Established regulations: Many countries in Latin AmericaâBrazil, Mexico, and Argentina, for exampleâhave well-established regulations governing the conduct of clinical trials and regulatory agencies that provide efficient review and approval processes.
- Shorter 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)
- Qualified investigators: Another important characteristic of the region is the availability of well-qualified medical professionals and investigators with clinical trial experience.
Do you have any advantages to add, as to why clinical research is moving to Latin America?Â Comment below.
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