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International Clinical Trials

Southern Exposure

Fernanda C Durán and Valeria Francesconi at PharmaNet Development Group tackle the challenges of coordinating clinical trials in Latin America

As biopharmaceutical companies have come under increasing pressure to develop and bring new medicines to market faster and cheaper, many have initiated clinical development projects in Latin America, a region that has emerged as a hospitable and productive venue for the conduct of clinical trials. However, for companies and CROs operating in Latin America, the region is not without its challenges. Establishing a presence in Latin America often means adapting to a commercial and cultural environment that is unfamiliar, both on a regional and local level: Latin America does not have a single, homogeneous culture, but one that includes more than 30 individual countries and territories spread across South and Central America, and the Caribbean. Although there are many cultural similarities among and between Latin American countries, companies need to be alert to the commercial and cultural nuances presented by each country.

In the days before widespread clinical development activity in Latin America, companies faced the challenge of training trial site personnel. This was largely a matter of assisting site staff in adapting to new data management technologies, although these technologies also needed to be made linguistically and culturally appropriate for specific Latin American populations. Fortunately, as companies have become more accustomed to operating in Latin America, technological issues have become less challenging. Yet, even as companies and CROs reach new levels of technological and cultural competence, they must still cope with regulatory issues that can be particularly challenging.

NAVIGATING THE REGULATORY ENVIRONMENT

Several Latin American countries have governments that are showing great interest in clinical trials, as reflected in continuous efforts to update these countries’ regulatory systems. Such efforts represent an ongoing challenge for trial sponsors, who must remain mindful of the nuances of each country’s system as the regulatory environment continues to evolve. While certain countries – Argentina, Brazil, Chile, Colombia, Costa Rica, the Dominican Republic, Mexico, Panamá, Peru and Uruguay – have specific regulations in place with regard to the conduct of clinical trials, other countries may only have general health regulations that do not focus specifically on clinical trials. Consequently, countries with specific regulations tend to have more clinical trial activity (see Table 1), and are generally more inclined to update these regulations on an ongoing basis.

 Table 1: Ongoing clinical trials in Latin America (as of 15 March 2010)  
 South America
 
 Central America
 
 Country Number of trials
Country/territory
Number of trials
 Argentina  971  Bahamas  10
 Bolivia  12  Barbados  2
 Brazil  1,665  Belize  4
 Chile  524  Bermuda  1
 Colombia  338  Costa Rica
 110
 Ecuador  52  Cuba  27
 Paraguay  6  Dominican Republic
 46
 Peru  456  El Salvador
 12
 Uruguay  28  Grenada  1
 Venezuela  95  Guadeloupe  2
     Guatemala  108
     Haiti  11
     Honduras  14
     Jamaica  12
     Martinique  2
     Mexico  1,131
     Nicaragua  4
     Panama  79
     Puerto Rico
 1,014
     Saint Kitts and Nevis
 1
     Trinidad and Tobago
 4
     Virgin Islands (US)
 2
Source: US National Institutes of Health, www.clinicaltrials.gov, accessed 15 March 2010  

Some of these countries are focused on updating regulations governing the confidentiality of patient information, patient safety and other issues pertaining to the protection of patients enrolled in clinical trials. Others may be focusing on more technical issues such as required documentation for manufacturing and data analysis. While these trends may be pervasive across the region, no two Latin American countries are approaching these issues in precisely the same way. One country’s regulatory agency may require a certain document not required elsewhere, while another country may have specific regulations in place for clinical trials of agents intended to treat certain diseases. Companies would thus be mistaken in grouping all Latin American countries under the same regulatory scheme.

In terms of regulatory processes, Latin America is more similar to the EU than to the US. Unlike the US, where a trial sponsor only needs Institutional Review Board (IRB) approval to initiate a clinical trial, sponsors of Latin American trials must obtain approval from a country’s Ministry of Health or competent regulatory authority for each study protocol; separate approvals must be obtained in each country in which the sponsor seeks to conduct a trial. These approval requirements can have a significant affect on project timelines: although various regulatory authorities are working to reduce approval timelines, review and approval of a trial protocol can still take as long as four to six months due to understaffing and other logistical issues. Nevertheless, there is evidence of progress. For example, in Brazil, the implementation of Resolution RDC 39/2008 has enabled sponsors to submit parallel (as opposed to sequential) applications for National Ethics Committee and Competent Authority approval; as a result, approval timelines have been shortened (1). Additionally, authorities in Brazil, Argentina and Peru have made a concerted effort to make clinical development more of a collaborative process by soliciting industry input in regulatory matters.

A MATURING CLINICAL TRIALS LANDSCAPE

The continually evolving regulatory environment reflects a maturation of the clinical trials landscape in Latin America. Initially, the majority of the trials in the region were conducted in Argentina, followed closely by Brazil and Mexico. Figures 1, 2 and 3 illustrate the tremendous growth in clinical trial activity in those countries over the last decade-and-a-half. Whereas Argentina reported only 80 trials in 1994, that number doubled by 2000 and exceeded 230 by 2007 (2). Similarly, Brazil has experienced exponential growth during this period, starting with approval of 30 trial protocols in 1995, increasing to 940 approvals in 2005, and peaking at 1,228 approvals in 2006 (the apparent drop-off in approvals in 2008 to 2009 is due to Resolution RDC 39/2008). In Mexico, the estimated number of clinical trials ballooned from 140 to 800 over a five-year period.

Today, clinical trials take place in nearly every Latin American country. Table 1 provides a tally of ongoing studies in various Latin American countries, as tabulated by the US National Institutes of Health Clinical Trials website.

BENEFITS OF CONDUCTING CLINICAL TRIALS IN LATIN AMERICA

For companies engaged in new drug development, Latin America offers several notable demographic and geographic benefits, including that of a large population stretching across two hemispheres: the estimated combined population of Latin America and the Caribbean exceeds 580 million people, and is projected to reach 802 million by 2050 (3,4). Approximately three-quarters of the population is concentrated in large urban areas, where the number of residents is expected to swell to 610 million by 2030 (5). Compared to other parts of the world, the concentrated population of Latin America allows for a more manageable number of trial sites, faster patient enrolment and easier patient followup. Additionally, the prevalence of Spanish-speaking populations (except in Brazil and in some Caribbean islands) requires less effort devoted to translating protocols, consent forms, patient instructions, and other clinical trial documents.

Latin America’s population and geography enable yearround recruitment of patients for studies of seasonal diseases such as influenza, while supporting continual, seamless enrolment for a variety of trials. Recruitment is often facilitated by a highly motivated pool of patients seeking access to novel therapies, and who generally forge close relationships with investigators while adhering conscientiously to trial protocols. Moreover, with fewer studies competing for patients, overall recruitment time tends to be shorter in Latin America than in North America and western Europe.

Latin America also offers an abundant supply of well-trained and motivated medical professionals and investigators. This benefit is largely due to the region’s long tradition of western medicine, as well as the fact that many Latin American physicians were trained in the US or Europe. Latin American investigators’ willingness to participate in clinical trials largely stems from their desire to work with novel therapies and technologies, and to be part of the international research community; many are also motivated by the opportunity for extra income and the means to improve site facilities.

Trial sponsors can be confident that the quality of the data from Latin American sites is comparable to that in traditional research markets. This is largely due to investigators’ familiarity with International Conference on Harmonisation/Good Clinical Practice (ICH-GCP) guidelines, as well as the knowledge they have gained from participating in guideline-compliant studies. Moreover, most Latin American countries have adopted and implemented national GCP guidelines. The large pool of GCPtrained and experienced investigators, combined with the sizeable patient population, has helped build an impressive track record of quality research projects in Latin America. Indeed, the US Food and Drug Administration (FDA) regard pivotal data from Latin America as acceptable, and have approved several products based solely on Latin American data.

LOOKING TO THE FUTURE

The estimated average annual growth rate for clinical trials in Latin America is expected to increase by roughly 20 per cent each year (6). By contrast, the total population of Latin America and the Caribbean is expected to increase at an average annual rate of 9.3 per cent over the next decade (4). Consequently, a growing number of clinical trials will be competing for a proportionately smaller pool of potential participants. Nevertheless, the continued availability of motivated patients, experienced investigators and quality data will help sustain Latin America’s status as a viable locale for clinical trials for the foreseeable future.

To be competitive in Latin America and to capture a large share of the projected growth in clinical trial activity, biopharmaceutical companies will need to mount full-service, multinational clinical development projects, as well as standalone, local work within the region. Their success will continue to depend upon maintaining a solid infrastructure to support clinical trials, bolstered by familiarity with local and regional customs and regulatory environments, as well as the availability of well-trained teams of professionals. CROs with a major presence in Latin America are thus well-equipped to help companies establish and maintain a foothold in this region. As companies face increasing pressures to develop new therapies and new devices more quickly and cost-effectively, those that include Latin America in their development strategies will be the ones best prepared to compete in the global marketplace in the 21st century.

References

1. Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency Brazil)

2. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (Argentina)

3. United Nations Economic Commission for Latin America and the Caribbean (ECLAC-CEPAL), Social indicators and statistics – population, http://websie.eclac.cl/ sisgen/ConsultaIntegradaFlashProc.asp. accessed 15 March 2010

4. Brea JA, Population dynamics in Latin America, Population Bulletin 58(1): pp3-36, 2003

5. Torres H, Social and environmental aspects of pre-urban growth in Latin American megacities, Presented at United Nations Expect Group Meeting on Population Distribution, Urbanization, Internal Migration and Development, New York, NY, 21-23 January 2008, http://www.un.org/esa/population/meetings/EGM_PopDist/P 10_Torres.pdf, accessed 15 March 2010

6. Thiers FA, Sinskey AJ and Berndt ER, Trends in the globalization of clinical trials, Nat Rev Drug Discov 7: pp13-14, 2008


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Fernanda C Durán is Executive Director, Latin American Operations, for PharmaNet Development Group. She has more than 25 years’ experience in conducting clinical research and working with contract research organisations in Latin America. She joined PharmaNet in May 2002, and has helped establish the company’s operations in Argentina, Brazil, Chile, Mexico, Peru, El Salvador and Costa Rica, among other countries. Fernanda is a member of the American Association of Pharmaceutical Physicians (AAPP) and the American Society of Clinical Pharmacology and Therapeutics (ASCPT). She is also founding member of the Argentinean Chamber of Clinical Research Organizations (CAOIC).

Valeria Francesconi is Regulatory Affairs Manager, Latin America, at PharmaNet. Valeria has been working in the CRO industry for over 15 years. Before joining PharmaNet in 2002, she worked at two large multinational CROs based in Argentina. She has been involved in regulatory documents review and clinical trial submissions to regulatory authorities, including coordination of study supplies importations and exportations as well as monitoring assistance activities in the Latin American region. Valeria has worked with clinical research regulations throughout the Latin America, including Argentina, Brazil, Colombia, Chile, Mexico and Peru. Her therapeutic experience includes oncology, ophthalmology, CNS, metabolic and infectious diseases.

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