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Clinical trials in Latin America

Clinical trials in Latin AmericaThe RAPS Focus article that we mentioned in our post on multi-country regulatory filing strategy also contains interesting details on the appeal of Latin America for clinical researchers (login required).

The authors mention seven reasons why medical device and pharmaceutical companies continue to make Latin America on of the "big three" emerging research markets:

  1. Quality and trust - Researchers have found GCP quality of clinical in Latin America (as in other emerging markets) to be as good as the quality of traditional regions. In addition, a 20-year history of "orderly conduct of trials" has inspired trust in local regulations.
  2. Reverse seasons - The fact that it is summer in Argentina and Chile when it is winter in the U.S., Europe, and Japan helps speed-up the development of drugs that treat seasonal diseases.
  3. Cost - The authors estimate that the cost of a typical Latin American trials is 20%-25% less than the cost of a U.S. trial.
  4. Geography - Because time zones overlap with the U.S., contact between site staff and a U.S.-based R&D organization is easy.
  5. Language - Latin America's language homogeneity (there are only two major languages, Spanish and Portuguese) make it an easy place to conduct trials.
  6. Hispanic ethnic group - As the largest minority group in the U.S., hispanics are an important market for drug and device companies. And that, in turn, makes Latin America an attractive and representative locale for clinical research.
  7. Market access - By conducting trials in a country, device and drug companies can launch new products faster and more predictably in that country.
While not everybody might agree with the trend to globalize clinical trials, with advantages like these, Latin America's importance in clinical research is sure to grow further.

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