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European Pharmaceutical Contractor

Pharma’s Future

Latin America is an emerging region with great potential due to its short regulatory timelines, experienced sites and lower costs. As an important destination for clinical research, the region is constantly being audited by both sponsors and the FDA alike, and continues to produce excellent results.

Performing research requires a systematic process that answers specific scientific questions; this eventually becomes new knowledge and technology which can be used to improve healthcare.Randomised control trials are the gold standard to assess the effectiveness of an intervention, and therefore have an impact in changing medical practice.

In the biomedical area over the last 60 years, clinical development (including epidemiological/observational and clinical) led to an increase in life expectancy of more than 22 years in women and 20 years in men in many countries. In Peru, for example, life expectancy in the 1950s was 52 and 55 years for women and men respectively;nowadays, life expectancy for the Peruvian population is 78.5 years for women and 70.4 years for men according to the Peruvian National Statistics Institution (1).This increase in life expectancy may be due to the improvement of healthcare systems, which is a clear reflection of the major discoveries that have been taking place over the last 50 years.

Meeting the Challenges

Clinical trials and epidemiologic studies have principally been conducted in North America and western Europe in the last 50 years.Trials in eastern Europe and South America began in the mid-1980s within the cardiovascular field. One of the first studies conducted in South America – the EMERAS study – was a large multi-centre randomised trial in 1986, with clear results (99 per cent complete data) that led it to be published in the Lancet (2).One pharmaceutical company that led the way in terms of investment in clinical trials in Latin America was Merck Sharp & Dohme (MSD).Peru was one of the initial countries where several Phase 2 and 3 trials were carried out in the late 1970s, and this opened the door for future companies. Since then,many more trials have been conducted successfully in several Latin American countries, including international trials (2). In fact, evidence shows that 15 to 25 per cent of patients in Phase 2 and 3 trials conducted as far back as the 1990s came from Latin American sites.

Another critical concern is the fact that, although 80 per cent of the global disease burden occurs in developing countries, the research conducted in these countries is less than 10 per cent (2). Research in these regions gives pharmaceutical companies and academia an opportunity to fill the gap and to be involved in the process of improving healthcare.The diseases that contribute to the burden differ substantially from those affecting the developed world, so clinical research in developing countries needs to continue to grows as the results obtained may be extrapolated back to their population. Even in instances where the disease is the same, the factors that contribute to them (nutrition level, socio-economic status, ethnic background and so on) are often different enough to make it worthwhile investing in research in developing countries.

Registered clinical trials correspond to the areas that are the leading causes of death reported for developed countries – oncology is the largest therapeutic area in terms of clinical trial activities with earlier phase trials (3).The largest oncology sites in each country in Latin America have been involved in many oncology trials, enrolling around five to 25 per cent of the patients worldwide. 

Investing in Emerging Markets

In recent years, a shift has been observed in clinical trials sponsored by the biopharmaceutical industry to so-called ‘emerging regions’, especially eastern Europe,Asia and Latin America (4).The majority of sites (67.7 per cent) registered before mid-2005 were in the US, compared with 46.9 per cent from this period onwards (4).The main reason for this shift is the ability to reduce operational costs and, at the same time, recruit a larger number of patients within established timelines, maintaining quality assurance certification and auditing by the industry, as well as by regulatory institutions such as the FDA.

The fact that countries in emerging regions, such as Latin American countries, are reaching an average number of sites per trial that have comparable capacity to that of developed countries, increases competition and lowers costs.According to Johan PE Karlberg, in one year Latin American countries showed more growth regarding sites compared to other countries worldwide, with Colombia showing 200 per cent site growth (5) (see Table 1).This is also true for the growth in the number of protocols per country, with Colombia again showing the largest growth rate (160 per cent in one year). Given these numbers, out of 50 countries selected Karlberg ranked Colombia as the fastest growing country in the region. Brazil was ranked at 8,Mexico at 10, Chile at 12 and Peru at 22. Nevertheless, in the past 10 years,pharmaceutical companies, such as MSD and Novartis,performed clinical trials where Peru and Colombia accounted for the majority of patients included worldwide. Ethics committees specifically dealing with Latin American countries have also grown in number in order to keep a pace with the scientific and technological developments globally. Ethics committees in Latin American countries are well-placed to prevent the violation of human rights occurring, such as the syphilis study in Tuskegee (US), or the clinical research that was performed during World War II (6).



Contract research organisations have also increased the number of clinical trials conducted in Latin America. Large CROs such as PPD, ICON and Quintiles have found the region to have investment opportunities, and have opened offices in larger cities.This exponential growth has pushed governmental institutions to grow as well, creating guidelines for performing clinical trials in the different countries in Latin America.These guidelines offer short operative times for approval, which makes emerging markets profitable to big pharmaceutical companies. In Figure 1, it is possible to compare different timelines for countries in South America (7). On average, it takes one month to obtain ethics committee approval, three months to obtain Ministry of Health (MoH) approval, and an additional month to receive the import license approval.



Maximising the Potential

With more and more clinical research taking place in Latin America, there are many benefits that can be accrued. For example, the Cardiovascular Risk Factor Multiple Evaluation in Latin America (CARMELA) study was carried out in seven major Latin American cities, designed to evaluate the prevalence of cardiovascular risk factors and common carotid far wall intima-media thickness distributions.A total of 11,550 individuals participated in this large cross-sectional observational study.The CARMELA study provided important epidemiological information regarding hypertension, hypercholesterolaemia, cigarette smoking, diabetes,obesity and metabolic syndrome in Latin America, as well as defining the reference values and population distribution of intima-media thickness in the Latin American population.

For instance a randomised, placebocontrolled paediatric trial in Latin American evaluating the safety, immunogenicity and efficacy of an attenuated rotavirus vaccine RIX4414 allowed 2,155 eligible infants in Brazil, Mexico and Venezuela to have access to a range of commercially available routine vaccinations and, in addition, acquire early protection against severe rotavirus gastroenteritis (8,9). Brazil also participated in trials that introduced highly active antiretroviral therapy (HAART) to the market. Indinavir was the third antiretroviral drug studied that proved to increase life expectancy in AIDS patients – one example for this is the PENTA4 trial (10). Sites in Peru and Brazil were also involved in trials that included linezolid and atazanavir.These examples demonstrate that the sites in Latin America are capable of proving good performance and excellent quality.

Other potential benefits include diffusion of medical practice, and greater patient access to high quality medical care.The benefits of conducting clinical trials in Latin America are:

  • Access to a large population, more than 500 million people live in the region and 70 per cent of the population live in urban areas. Four of the region’s largest cities – Mexico City, Sao Paulo, Rio de Janeiro and Buenos Aires – are among the largest urban centres in the world
  • The investigators and all the medical and non-medical staff are well qualified, and many of them have experience in conducting clinical trials.They also have knowledge of the International Conference on Harmonization (ICH) guidelines and training in Good Clinical Practice (GCP) standards
  • Many countries in Latin America have well established regulations and the regulatory agencies are providing more efficient processes to help
  • All Latin American countries, with the exception of Brazil, speak Spanish.This makes it easier to translate documents and simplifies communication
  • Latin America has become one of the fastest growing pharmaceutical markets in the world, representing approximately 25 per cent of global pharmaceutical sales in 2000 (11)
Ethical Implications

Many ethical questions arise when conducting a trial in developing countries. One of the main concerns is the fact that part of the population does not have access to treatment, and the standard of care is not the same in all of the places where the trial is being performed; this can lead to a conflict of interest when recruiting patients. Another important ethical dilemma is the fact that developing countries will not have access to the benefits of the trial once the investigation has concluded and the drug becomes approved in the market.We need to ensure that the growth in clinical trials worldwide is accompanied by greater availability of the drugs in the countries where the trials are conducted (12).

The sponsor must also take into consideration the cultural framework and must overcome this barrier without compromising the population’s beliefs.To tackle this issue, local personnel must be involved in the study from the start and have direct contact with the participants (2).

Conclusion

Research through clinical trials is able to offer excellent medical treatment to the public and improve healthcare systems, in turn providing better treatments than might otherwise be available. For many years the US has been the heart and soul of the pharmaceutical business and, as a result, over half of leading pharmaceutical firms’ profits comes from America alone. However, the future now lies in the developing world. For example, Andrew Witty of GlaxoSmithKline declared that “emerging markets would be at the heart of his growth strategy” (13). Meanwhile, Pfizer has announced a restructuring plan that will make emerging markets a priority. The market in the developing world will grow enormously, making it a ‘friendlier environment’ for the industry to do business in, which, in turn, will also have an impact on the economy.

Clinical research brings knowledge to the countries involved, improves quality, creates systematic information in developing countries, increases economic resources and technologic resources, creates job opportunities and improves clinical education. Latin America is taking advantage of all of these benefits provided by research.

Widespread inclusion of the ICH-GCP guidelines may have a strong contribution to the globalisation of clinical research. Latin America continues to be an attractive option because of sites’ excellent staff and low costs. Pharmaceutical companies must maintain gold standards and make sure that the patients included in studies receive the best treatment possible without compromising their health after the research has concluded.

References
  1. Peruvian National Statistics Institution, www.inei.gob.pe
  2. Yusuf S, Clinical research and trials in developing countries, Statist Med 21: pp2,859-2,867, 2002
  3. Karlberg JPE, Trends in disease focus of drug development, Nature Reviews Drug Discovery 7: pp639-640, 2008
  4. Thiers FA, Sinskey AJ and Bendt ER, Trends in the Globalization of Clinical Trials, Nature Reviews Drug Discovery 7: pp13-14, 2008
  5. Karlberg JPE, Globalization of sponsored clinical trials, Nature Reviews Drug Discovery 7: p458, 2008
  6. Reverby SM, More than Fact and Fiction, Hastins Center Report, September to October 2001
  7. Considerations for conducting clinical trials in Latin America, Pharmaceutical Product Development (PPD), 2009
  8. Schargrodsky H, Hernández-Hernández R, Champagne BM, Silva H, Vinueza R, Ayçaguer LCS et al, CARMELA: Assessment of Cardiovascular Risk in Seven Latin American Cities, The American Journal of Medicine 121(1), January 2008
  9. Salinas B, Schael IP, Linhares AC, Palacios GMR, Guerrero ML, Yarzábal JP et al, Evaluation of safety, immunogenicity and efficacy of an attenuated rotavirus vaccine, RIX4414: A randomized, placebo-controlled trial in Latin American infants, The Pediatric Infectious Disease Journal 24(9): pp807-816, 2005
  10. Aboulker J-P, Babiker A, Carriere I, Darbyshire JH, Debré M, Giaquinto C, Gibb DM, Harper L, Newberry A, Saidi Y and Tudor-Williams G, A randomized doubleblind trial of the addition of lamivudine or matching placebo to current nucleoside analogue reverse transcriptase inhibitor therapy in HIV-infected children: the PENTA-4 trial, AIDS 12(14): F151-160, 1998
  11. Glancszpigel D, Clinical trials in Latin America: meeting the challenges can reduce time-to-market, Applied Clinical Trials, May 2003
  12. Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM et al, Ethical and scientific implications of the globalization of clinical research, NEJM 360: p8, 2009
  13. Racing down the Pyramid; Big drugmakers’ love affair with America is coming to an end, The Economist, 13 November 2008, www.economist.com/node/12601852

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Eduardo Gotuzzo is the General Manager of Gotuzzo Asociados. With over 330 publications in international journals and more than 40 book chapters, he is a respected investigator with an international reputation. In addition to being the past president of the International Society of Infectious Disease, International Federation of Tropical Medicine and Pan-American Association of Infectology, Principal Professor of Medicine at Universidad Peruana Cayetano Heredia and Medical Director of Upjohn-Pharmacia for more than 20 years, he has also worked as a principal investigator for several projects. Email: egotuzzo@lara-cro.com

Melissa Brosset worked as a Project Manager from January 2009 until December 2010 at Gotuzzo Asociados before becoming a Clinical Trials Coordinator. She is in charge of all the regulatory affairs in Peru and Colombia. She obtained her Medical Doctor degree at Universidad Peruana Cayetano Heredia, in December 2008. Email: mbrosset@gotuzzos.com

Camila Masias graduated as a medical doctor in 2008 from Universidad Peruana Cayetano Heredia. She started working in Gotuzzo Asociados in February of 2008 as a Project Manager, and one year later she was the Clinical Trials Coordinator, with responsibility for all the clinical trials in the organisation, managing regulatory affairs, as well as monitoring and supervising studies. Email: cmasias@gotuzzos.com

Natalia Freundt has been a Project Manager at Gotuzzo Asociados since February 2011. She completed her Bachelor of Science in Biochemistry at McGill University in 2004. In 2005, she worked in the Immunochemistry Department – Preclinical Services of Charles River Laboratories in Montreal, Canada. In December 2010, she obtained her Medical Doctor degree at Universidad Peruana Cayetano Heredia in Lima, Peru. Email: nfreundt@gotuzzos.com

Maria Jose Inurritegui studied medicine at Universidad Peruana Cayetano Heredia from 2004 to 2010. She graduated as Medical Doctor and has been working at Gotuzzo Asociados as Project Manager since February 2011. Email: mjinurritegui@gotuzzos.com
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Eduardo Gotuzzo
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Melissa Brosset
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Camila Masias
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Natalia Freundt
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Maria Jose Inurritegui
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