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With 28 million people (July 2005 est.) Peru has the fifth largest population in Latin America; a large proportion of this population (8 million) is found in the capital, Lima. Most medical centers are concentrated in Lima, where patients are generally more affluent and participation in clinical trials may offer much better medical treatment than patients usually receive.
Peru offers a strong patient recruitment and retention arena. Although Peru has increased its clinical research activity considerably over the past years, there are fewer competing studies in the country than in other regions of the world. In 2004, more than 100 trials were performed – twice as many as in 1999 – and in 2005, a considerable increase in Phase II studies was observed. Still, two out of three trials performed are Phase III, with the most important therapeutic areas being Oncology, Infectious Diseases, Endocrinology, Respiratory and Cardiology.
Reverse seasons (it is summer in Peru when it is winter in the United States) allow companies to test drugs for seasonally induced diseases year-round by including Peru and other southern hemisphere countries in which Kendle has operations.
In 2006, Peru enacted new Clinical Trial Legislation that further strengthens the legal foundation to Peru’s already well-established regulatory process and is based on ICH GCP and the Declaration of Helsinki. Ethics Committee and Ministry of Health approval take approximately 4.5 months and the subsequent import license takes seven working days. Kendle obtained its official registry in September 2006 since all CROs and investigational sites need to be registered with the MoH.
The FDA has been inspecting clinical trials conducted in Peru since 1996. Since 2000 there have been several inspections, all with positive results (75 percent with the best possible inspection result of NAI). It is also important to note that the Peruvian MoH started inspecting clinical trials in 2004.
Vaccine Trials
There is a high level of access to specialized patient populations to test vaccines: most patients are previously untreated and many diseases that have been eradicated in the United States and Europe still exist in Peru.
Data for Japanese Market
Peru has one of the three largest concentrations of ethnic Japanese living outside of Japan. This is important because Japan is the second largest consumer of pharmaceutical products in the world, but it is difficult to enroll patients in Japan because of the high number of competing trials. However, the adoption of the International Guideline on Ethnic Factors in the Acceptability of Foreign Clinical Data allows the drug approval authorities of Japan to accept data from studies that include ethnic Japanese living outside of Japan.
Pediatric Trials
In Lima, 35 percent of the population is less than 18 years of age (8.4 percent is 1-4 years; 8.6 percent 5-9 years; 9.1 percent is 10-14 years; 9.3 percent is 15-19 years). Recent trials have shown that these pediatric patients are eager to participate and their parents are willing to give their consent. |
