Parexel talks clinical research in Latin America

Brazil, Argentina, Mexico and perhaps surprisingly, Columbia, are the most popular clinical trial locations in Latin America, and Columbia is expected to undergo a period of rapid growth over the next few years, along with Peru and Chile. Cost savings is not the only driving factor, Graciela Racaro, Parexel's director of clinical & regulatory in Latin America, told Outsourcing-Pharma at the recent Drug Information Association (DIA) conference in Atlanta. "Many of these countries have now put internationally-acceptable legislation and regulations in place in regard to clinical research and have good facilities, infrastructure, and access to large patient populations."​ While regulatory timelines are still considerably long - it often takes 9 to 12 months to have a site up and running - this is often made up for by the "much shorter"​ recruitment times, said Racaro. Some sites have even recruited after two days, she added. When it comes to marketing a drug in the region, it helps to have "local hands on involvement from doctors,"​ and these relationships with doctors are usually formed during the clinical trial process, "so it is also​ attractive to conduct research in these countries from a drug marketing perspective too."​ According to Racaro, Brazil is the dominant country, with a population of 180m who display both 'western' and third world diseases. Figures provided at the DIA by Dr Granville Garcia de Oliveira, a representative from the Brazillian regulatory authority, ANVISA, showed that 923 clinical trial applications (CTAs) and 56 new drug applications (NDAs) trials were approved there in 2006. However, according to a presentation given in April in London by Dan McDonald, vice president of Strategic and product development for consultancy firm D. Anderson & Company, Argentina now runs 32 per cent of Latin America's clinical trials, while Brazil runs 29 per cent. Argentina, with a population of 38m, is more advanced than Brazil in terms of its regulatory system, said McDonald. But, according to Dr Analía Perez, an Argentinian regulatory authority (ANIMAT) representative, speaking at DIA, only 223 clinical trial protocols were approved in Argentina last year. So there appears to be a large discrepancy in numbers between Brazil and Argentina and some conflicting information. The confusion may lie in the fact that in Brazil you need to submit each investigator to ANVISA, so it is one CTA per investigator, said Racaro. So just because 923 CTAs were issued by ANVISA, it does not mean that this many actual clinical trial protocols were approved. "If you compare Argentina and Brazil, Brazil had more trials approved in 2003 (192 vs 119) and 2004 (214 vs 158) than Argentina, but Argentina had more trials approved in 2005 (150 vs 126) than Brazil,"​ said Racaro. The final numbers for 2006 are unavailable publicly at this point. So the reality may be that the two countries are quite close in the number of clinical trials they are now running and they may switch between positions one and two from year to year. The clinical trials industry in Brazil finally began to evolve in 1996 when it established regulations that adhered more closely to International Conference on Harmonisation (ICH) guidelines, along with the establishment of a national bioethical committee that investigates institutional review boards (IRBs). Although Argentina is the most advanced Latin American country in terms of regulatory processes, trial approval times are still slow, officially taking around 90 days but realistically talking 120 days. The country is also particularly popular for running trials because of its market appeal. If a drug is already marketed in 'tier 1' countries, such as in Europe and the US, only 'a couple' of forms need to be submitted, along with local clinical trial data, in order to seek approval to market the drug in Argentina. Mexico, with its population of 100m sits in third spot in terms of international clinical research, although there are no official trial statistics for this country as yet. The country has the world's highest diabetes prevalence at 8 per cent, and so diabetes research in this is also gaining popularity here. "We are now doing a lot of diabetes research in Mexico, over the past two to four years we have had over 10 ongoing diabetes trials there,"​ said Racaro. Columbia is perhaps the surprise performer. "It is growing in popularity because of its large patient population, 44m, and its good investigators and infrastructure,"​ said Racaro. "People are often dubious about conducting clinical research in the country because of its political history but once they 'take the risk' and try it out there, they usually go back and work there again." ​There are no official trial statistics for Columbia as yet. Meanwhile Peru, with a population of 28m, is now earmarked as another growth area since it changed legislation last year (which was again updated and improved upon last month) so that contracts between investigators and sponsors do not need to be signed before a clinical trial approval is submitted to the country's Ministry of Health (MOH). "This will make the trial application process quicker,"​ said Racaro. There were 58 clinical trial authorisations in Peru last year. Chile is another country showing promise in the clinical trials arena, with a population of 16m, said Racaro. "In an informal meeting with the authorities, they mentioned to one of our representatives that 168 studies were approved in 2006, (local and global studies, Phase I to IV)." Despite the progress being made in Latin America, clinical trial samples still need to be shipped to a central laboratory in the US for testing as local facilities are generally inadequate, said Racaro. One other particular problem the firm is now facing in Latin America is that the number of experienced investigators is reaching saturation point. "We are having to use the same investigators over and over again for all our trials and because some of them are involved in more than one study at a time there are potential conflicts of interest,"​ said Racaro. "Our strategy is to train more investigators, which we are now doing." ​ Meanwhile, Bolivia and Paruguay are not used for international clinical research as they do not have regulations in place, nor the infrastructure and facilities, and this scenario is unlikely to change in the near future, said Racaro. "This is partly because these countries do not require that local clinical trial data is obtained before foreign drugs can be approved, where as other Latin American countries do require clinical data that matches up to both local and international regulations."​ In regard to Latin America's appeal for clinical research compared with other emerging regions, Racaro said: "I don't see the emerging markets as competing against one another, as each one can provide a solution to [the problems currently being faced in] clinical research."​ For example, Latin America is particularly good for breast and lung cancer and cardiovascular studies, multiple sclerosis and diabetes, while Asia is better for stomach and liver cancer and hepatitis C.