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The discovery of new compounds targeted to less frequent clinical conditions has increased markedly during the last five years. The preclinical and phase I development steps of such new molecules have no barriers, but many obstacles are observed at phase II and III studies.

Cost per patient of clinical research in this patient population is much higher than what is observed in more frequent conditions, due to many reasons including the need for large number of countries and sites required to find the patients, and the low number of patients per study site.

To speed up the development of the clinical phases, consequently reducing the costs and time to patent expiration, pharmaceutical industries are looking for countries with large patient populations concentrated in urban centers, with proven expertise in clinical research. Among these countries is Brazil, with 186 million inhabitants of diverse ethnical background, concentrated in high density urban areas, and high birth rate.

INTRIALS has been proving its competency to rescue studies where recruitment is far below what is desired. An example of this can be seen in the two graphics below from a pediatric study in a rare lung disease. USA began recruiting in 2003. Australia, Brazil and Hungary were involved in the study only in 2005. Up to May 2006 Brazil has enrolled 11 patients in only two sites, representing 55% of the total number of patients enrolled in the world.

  • USA: 7 sites were activated from 2003-2005. Currently, 6 patients are included.
  • Australia: 2 sites are activated and one patient is included.
  • Hungary: one site is activated and 2 patients are currently included.
  • Brazil: INTRIALS activated 2 sites in 2005. In May 2006, less than one year later, 11 patients were included.

Contact us to access a presentation about the region and to learn more about how INTRIALS can assist you conduct studies in Latin America.

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