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Rediscovering Latin America

Clinical research in Latin America began in the 1990s – a time when highly qualified physicians were available, but a solid regulatory infrastructure was missing. By the mid 2000s, the exponential growth of worldwide clinical research had spread to Latin America and, by then, the system was more prepared in terms of regulatory requirements, plus experienced sites and state-of-the-art institutions existed.

Today, as the industry moves on from the economic crisis of 2008 to an era of new growth in the global market, Latin America has to be rediscovered. The region has new regulations, the number of organisations operating in the area has increased, and there has been considerable political development, enabling it to foster clinical research more effectively and take the region to a higher level.

This article aims to describe the most important events in the clinical research environment within the region, putting emphasis on those countries where clinical research has evolved markedly in recent years, as well as those who have conducted the highest numbers of trials (see Figure 1).



UPDATES IN LOCAL REGULATIONS

In recent years, the majority of Latin American countries have worked on creating new local regulations and improving the overall submission and approval process.

Argentina

On 5 November 2010, the National Administration of Drugs, Food and Medical Technology (ANMAT), a department of the Argentinean Ministry of Health issued a new regulation (Disposición 6677/2010) to update the former national regulations on clinical trial activities and the requirements for submissions and approvals (2). This new regulation includes changes and clarifications that simplify and improve the efficiency of the overall regulatory process in Argentina, including:

  • Clear submission requirements, drug labelling information and informed consent forms (ICFs)
  • The use of a summarised ICF for emergency situations
  • The submission of clinical study documents for evaluation (protocol, IB, ICF and import license request) simultaneously with the submissions to the sites’ local ethics committees saving on average four weeks in the overall process (see Figure 2)
  • The presence of a witness is only required for those cases where an independent judgment may be jeopardised by cultural, educational, social, economic and/or situational vulnerability (for example in an emergency)

The current ANMAT administration considers clinical research as a state policy, and one of its strongest concerns relating to the regulatory process is concerning to its deadlines.

Up until November 2010, an ANMAT approval took approximately 100 to 110 days. Efforts are being made to reduce this period even more, and it is expected that, if this trend is maintained, a maximum of 90 days can be achieved by the end of Q1 2011.

ANMAT is also working to create a ‘Federal ANMAT’ in which the entire regulatory agency’s effort will be focused on each national jurisdiction. The goal is to achieve consistency and standardisation within the wider legal framework through forums, discussions and regional participation events in order to ultimately remove the requirement for a new clinical research protocol submission, previously approved by ANMAT, being reviewed repeatedly in every jurisdiction nationwide.

In 2010, ANMAT also took an important step by generating an online database of all clinical trials conducted in Argentina. This portal is available to the general population and can be accessed through the administration webpage (3).

Finally, in January 2011, the Domestic Trade Secretary from the Argentinean government created the National Commission for the Development of Clinical Pharmacology Research (CODEINFAC). This was considered to be a milestone for Argentina and its pharmacological industry. The first meeting was held in February 2011, with several industry representatives from the government and the pharmaceutical industry present, including the Secretary of Domestic Trade, ANMAT, customs and several pharmaceutical industry chambers. The meeting’s primary goal was to define an action plan to expand clinical research in the country. ANMAT is already working with a clear agenda here and customs is evaluating alternatives to meet the demands for clinical research importation and exportation flows to make them more efficient. 



Brazil

The most recent changes to regulations occurred on 5 June 2008, when the National Agency of Sanitary Vigilance (ANVISA), a part of the Brazilian Ministry of Health, issued Resolution 39 (replacing Resolution 219 from 2004) (4). This represented a major change in the Brazilian regulatory process, which resulted in an update and clarification of the documents required for clinical research. The most important changes include the fact that: ANVISA now issues only one approval for all sites (previously one individual approval per site was required); the approval is released without the need of having the CONEP approval (making ANVISA and CONEP processes simultaneous); and the importation license approval is issued by ANVISA at the same time the protocol approval is released (making the importation process immediate after approval is obtained).

The current timelines in Brazil range from 20 to 28 weeks from the first site application to country approval and medication at sites. The eight-week range depends primarily on the study design, the complexity of the protocol and the vulnerable populations involved. Brazilian regulatory processes and timelines are presented in Figure 3, where it is clearly shown how CONEP and ANVISA reviews are now simultaneous.



Colombia

The National Institute of Drugs and Food Vigilance (INVIMA) regulates and controls clinical research activities in Columbia (5). At approximately four months, the regulatory approval timelines are some of the shortest in the region, including the importation process. Clinical research sites in Colombia must be audited by INVIMA for certification as a research centre, and this also requires GCP certification.

At the start of 2011, the Pan-American Health Organization (PAHO) certified INVIMA as the National Regulatory Authority for Drugs in Latin America. This is the highest PAHO qualification, thereby positioning INVIMA as a National Regulatory Authority within the international sanitary environment. This certification represents a meaningful step towards international recognition and competitiveness.

INVIMA will participate as a reference country in the discussion of strategic issues for the regulation of drugs in the region and the harmonisation of pharmaceutical regulations in the Americas, as well as in the elaboration and implementation of programmes in coordination with PAHO to strengthen other sanitary agencies in the continent. The only other agencies with this certification in the region are ANMAT in Argentina, ANVISA in Brazil, and the Center for State Control of Drug Quality (CECMED) in Cuba.

Chile

Chile has also worked extensively to establish proper guidelines for clinical research development. Quality and control are the main bywords around the initiatives taken by the Institute of Public Health (ISP), within the Chilean Ministry of Health in Chile (6). To achieve further development, there are changes being lined up in the institutional, legal and ethical fields.

The institutional initiatives include the development of a web portal for the registration and follow-up of clinical trials conducted in Chile, as well as the development of the National Agency of Drugs (ANAMED), which will report to the ISP and will have the duties of regulation, quality control and registration of bioequivalence trials, in addition to co-participate with the current Office of Clinical Trials at the ISP.

As part of the Legal Initiative, a new regulation will be issued by updating Norm 20,120 of clinical research in human subjects. This new rule will regulate the activity of ethics committees, setting timelines for the approval and revision of protocols submitted for review. Other legal initiatives are also in progress, such as the development of a medicine policy for generic drugs and bioequivalence, integrating the PAHO initiative towards the rational use of drugs, and the generation of a new national policy for medicines.

Where ethics is concerned, the creation of a bioethics unit within the Ministry of Health is currently under consideration. The unit would supervise all observations brought by the ethics committees, collaborate in conflict resolution and confirm clinical trials based on the portal registry.

Mexico

In Mexico, the Federal Commission for the Protection against Sanitary Risks within the Ministry of Health (COFEPRIS) is in charge of the review and approval of clinical trials to be conducted at Mexican sites (7). In the last year, it has focused on improving the regulatory processes by implementing efficient strategies to meet this goal. COFEPRIS has been open to input from all the parties involved in the clinical research area and has noted that they will continue overseeing clinical research adherence to the Mexican Health Regulation and ICH-GCP guidelines. As a part of this commitment, it is expected that during 2011 the Pan-American Health Organization will certify this entity as a National Regulatory Authority for Drugs, exactly as in Argentina, Brazil, Colombia and Cuba.

Peru

During 2010, the Peruvian government actively helped generate the conditions that promote the investments in the clinical research field. It created a series of rules to regulate and boost the conduct of clinical trials within the framework of international bioethics and good clinical practice standards.

The National Health Institute (INS) is the government agency in Peru evaluating protocols’ dossiers and coordinating the research and development among investigators, research sites and ethics committees (8). It recently created a web page for clinical trials especially designed for sponsors, investigators and the general population containing statistical information on clinical trials since 1995.

Peru is one of the countries in the region showing major growth in the clinical research area, with 1,194 clinical trials evaluated by the INS between 1995 and 2010 and, as per the current legislation, a protocol approval should be obtained within 40 days. Figure 4 shows the increase over a five-year period.



CRO CHAMBERS


In 2006, CRO chambers, CAOIC and ABRACRO, were founded in Argentina and Brazil, respectively (9,10). This was a milestone for the clinical research environment in the region, and these pioneer organisations set the pace for the rest of the countries in Latin America. There are currently several other chambers, such as ACROM in Mexico and ACROCHI in Chile (in process of approval). These non-profit entities represent the companies that participate in the pharmaceutical and biotechnological industries, with the aim of:

  • Preserving the rights of clinical trials’ participants
  • Facilitating the development of human resources trained to conduct quality clinical research
  • Cooperating with other parties in the private and public sectors that are involved in clinical research, in order to position the region as a reference for the industry
  • Providing support to generate an adequate regulatory context for that purpose

SITES’ PERSPECTIVE

With the continued development and improvement of regulations, clinical research sites have also become more professional and experienced. With more than 15 years in the field, they now constitute solid groups of investigators trained in bioethics and good clinical practice who conduct their activities within institutional infrastructures in constant expansion and modernisation. It is now very common to find fully developed clinical research units within health institutions whose function is to coordinate and manage every trial at the site. They run their activities with a dedicated team of highly trained study coordinators, nurses and pharmacists who support the conduct of the studies, following international ICH-GCP guidelines, local regulations and internal SOPs.

The number of clinical research sites in the region has terrific growth potential relative to the countries’ population, as shown in Table 1, and there are thorough training plans in place for newly-established sites, as required by the newest regulations, to guarantee a safe and successful conduct of trials. Not only does the development of clinical research sites include internal specialisation and process improvement, it also includes the network that sites have established among themselves through associations or organisations.

There are a variety of clinical research investigator associations in several countries in Latin America, for example: the Clinical Investigators of Buenos Aires City (SICCBA), the Clinical Investigators of Province of Buenos Aires (SICCPBA), the Oncology Clinical Investigators in Argentina (GAICO), and the Clinical Investigators of Brazil (APCB), among others. These entities operate as robust forums with the primary objective of facilitating discussion and debate on alternatives to improve the activity, and they often interact directly with the regulators, pharmaceutical companies and CROs.



QUALITY ASSURANCE

Quality is always a major concern, but it is also improving in the region, with inspections by every local regulatory agency rapidly spreading. These are conducted while studies are active and immediately after the first patients’ enrolment, allowing early adjustments in case of any identified deviations.

ANMAT in Argentina has been conducting clinical research sites inspections for many years now, setting the bar high with good results regarding compliance and quality. ANMAT is striving to double their inspection team this year and achieve an adequate number of inspections to cover most clinical trials conducted in the country. Other agencies in the region have followed this example, and now local agency inspections are being conducted in: Brazil by ANVISA, Colombia by INVIMA, Chile by ISP, Mexico by COFEPRIS, and Peru by INS. Peruvian Ethics Committees, sites and CROs are audited by the INS. These inspections increased from 30 in 2004 to 175 in 2009 (see Figure 5). This is a continuing trend across the region, with similar increases over the past few years in all the Latin American countries.

 

LOOKING TO THE FUTURE

From all perspectives, the clinical research environment in Latin America is becoming more professional, with improved regulations that enable predictable and sustainable timelines, more experienced and knowledgeable sites to allow the successful conduction of Phase 1 to 4 trials, high data quality standards and a stronger interaction among clinical research professionals from all sectors, including regulators, industry professionals and investigators.

All the concepts described above reassert the interest of all the parties involved in making the region increasingly attractive, both in terms of data quality and regulatory deadline efficacy, so that the global pharmaceutical industry will re-discover Latin America as one of the best areas to develop clinical research activities for drugs and medical technology. 

Acknowledgement
The authors would like to thank Renata Holender (in Brazil), Carol Thomas (in Chile) and Adriana Chavez Blanco (in Mexico) of Omnicare Clinical Research for their helpful information and support.


References

  1. US National Institute of Health, http://clinicaltrials.gov/ ct2/results/map/click?map.x=226&map.y=198
  2. ANMAT: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (National Administration of Drugs, Food and Medical Technology), Argentina, www.anmat.gov.ar/webanmat/Legislacion/Medicamentos/ Dispo_6677-10.pdf
  3. ANMAT Clinical Trial Database, www.anmat.gov.ar/ aplicaciones_net/applications/consultas/ensayos_clinicos/ principal.asp
  4. ANVISA: Agência Nacional de Vigilância Sanitária (National Agency of Sanitary Vigilance), Brazil, www.ANVISA.gov.br
  5. INVIMA: Instituto Nacional de Vigilancia de Medicamentos y Alimentos (National Institute of Drugs and Food Vigilance), Colombia, www.invima.gov.co
  6. ISP: Instituto de Salud Pública de Chile (Institute of Public Health ISP), Chile, www.ispchl.cl
  7. COFEPRIS: Comisión Federal para la Protección contra Riesgos Sanitarios (Federal Commission for the Protection against Sanitary Risks), Mexico, www.cofepris.gob.mx
  8. INS: Instituto Nacional de Salud (National Health Institute), Peru, www.ins.gob.pe/RegistroEC
  9. CAOIC: Cámara Argentina de Organizaciones de Investigación Clínica (Argentine Chamber of Clinical Research Organizations), www.caoic.org.ar
  10. ABRACRO: Associação Brasileira de Organizações Representativas de Pesquisa Clínica (Brazilian Association of Clinical Research Organizations), www.abracro.org.br
  11. US Census Bureau, www.census.gov/ipc/www/idb/rank.php

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Maria Alejandra Espinosa is Project Director, Latin America Regional Coordinator, for Omnicare Clinical Research. Alejandra has a Licentiate Degree in Biological Sciences and a specialisation in Molecular Biology and Epidemiology. She has more than 10 years of experience in conducting clinical research and working with CROs in Latin America. She joined Omnicare Clinical Research in February 2001, and has helped grow the company’s operations in Argentina, Brazil, Chile, Mexico and Peru. She is also a participant of the Argentinean Chamber of CROs (CAOIC) on the company’s behalf. Email: mariaalejandra.espinosa@omnicarecr.com

Ivana Etcheverry is Project Manager for Omnicare Clinical Research. Ivana has a Licentiate Degree in Biochemistry. She has over nine years of experience in conducting clinical research and working both at CROs and pharmaceutical companies in the Latin America region. She joined Omnicare Clinical Research in October 2006. Her professional background includes management expertise and experience in multiple therapeutic areas, Phase 1 to 4 and large-scale global pivotal studies. Email: ivana.etcheverry@omnicarecr.com
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