Clinical trials have increased significantly throughout Latin America due to many factors. Research & Development RA SA has strong experience in developing and using these factors to conduct successful trials. They include:

• Strong enrollment rates.
• Good patient compliance and retention.
• Large metropolitan areas provide patient concentrations in large public hospitals (Mexico City, Buenos Aires, and Sao Paulo are 3 of the most populated cities in the world yielding enrollment efficiencies).
• Reliable, well trained, and eager investigators.
• Strong patient-doctor relationship built upon the health infrastructure of each country.
• Ethnic diversity covering most of the world´s population – Large Hispanic populations as well as other European, Oriental, and African populations.
• Quality assurance through strong adherence to GCP - ICH norms.
• Competitive costs.
• Availability of treatment-naive patients.
• Substantial market for later sale of approved drugs.

The above factors have lead to a 1,000% increase in the last 5 years in trials run in Latin America (DataEdge, White Paper, November 2001). In addition, the FDA positively views the inclusion of Hispanics in clinical trials since they are the largest minority in the USA at 12% of the population, but are often under-represented in clinical trials at only 3% participation (David Lepay, Head of the GCP Office of the FDA, at the DIA 1st Latin American Congress of Clinical Research, March 1st, 2002).

Latin America offers a number of advantages as a location for clinical trials —a large population, highly qualified medical personnel, a tradition of Western medicine, and well-established regulations for clinical trials in most countries.
The ready access to these resources can help pharmaceutical companies reduce trial delays and speed up development times. At the same time, those companies face significant cultural, medical, regulatory, and logistical challenges inherent to conducting trials in Latin America. Sponsors willing to take the time to understand and adapt to the differences, however, can rise to the challenges and successfully conduct a wide range of clinical trials in Latin America to support an efficient global drug development program.


Established regulations:

Many countries in Latin America—Brazil, Mexico, and Argentina, for example—have well-established regulations governing the conduct of clinical trials and regulatory agencies that provide efficient review and approval processes. Most of the other countries in the region have some kind of legislation or Ministry of Health regulations covering the conduct of clinical trials. With the proper level of preparation and a knowledge of each country’s requirements, it is possible to undertake successful studies in such nontraditional locations as Chile, Ecuador, Colombia, Perú and Uruguay.


Potential subjects:

For pharmaceutical companies seeking to speed the drug development process, a key benefit of conducting
clinical trials in Latin America is access to a large subject population. More than 500 million people live in the region, with approximately 70% of that total concentrated in urban areas. Some of the Capitals cities in Latin America— Sao Paulo and Rio de Janeiro, Brazil; and Buenos Aires, Argentina—are among the largest urban centers in the world, with populations between 10 and 20 million people. These population concentrations offer significant advantages for subject recruiting and trial logistics.
Equally important, a large percentage of this population qualifies as naïve subjects —who are increasingly difficult to find and recruit elsewhere.

The regulatory environment:

The region’s increasingly sophisticated regulatory environment demonstrates the evolution of pharmaceutical research in Latin America. In many countries specific legislation directly regulates the conduct of clinical trials.

Brazil: One major legislative provision details the processes and procedures that sponsors must follow to gain approval for clinical trials, including reviews of protocols, consent forms, and investigators by a local ethics committee, the Research & Ethics National Commission (ANMAT, Administración Nacional
de Alimentos, Medicamentos, y Tecnología Médica), and the Health Care Surveillance Office (ANVISA, Agência Nacional de Vigilância Sanitária).

The latter two are under the jurisdiction of the national Ministry of Health (MOH). The MOH must also authorize research sites.
Another legislative provision specifies the responsibilities of the investigators.

Argentina: A specific agency within the MOH regulates clinical trials—the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT).
This agency has the power to authorize and monitor all clinical trials in Argentina. Its regulations contain detailed provisions outlining the obligations of sponsors and investigators and the participation of independent ethics committees or review boards. ANMAT also performs audits of clinical trials.

Chile, and Uruguay also have formal MOH involvement in clinical trial approvals. Most of the other Latin American countries have some type of public health or regulatory oversight for clinical studies.

Approval times for ethics committees or review boards are typically 30 to 60 days.
Approval times for the ministries of health or their agencies can range from 30 to 90 days.
In some countries, the growing workload of the regulatory agencies is slowing the review process. Most Latin American regulatory bodies are, however, working to increase their clinical trial resources and shorten approval times to encourage clinical research in their countries.

The ICH Guideline for Good Clinical Practice is well understood in Latin America, and investigators in most countries follow that guideline. In some countries, however, the regulations governing ethics committees do not fully comply with the ICH guideline for the type and number of members, SOPs, or frequency of meetings.
In those cases, sponsors should make use of an independent review board in Latin America that does meet ICH standards.
In recent years, adherence to GCP standards for clinical trials has been growing in Latin America, but the regulatory agencies in most countries are just beginning to gain experience with these standards.

As a result, the regulatory environment in Latin America continues to evolve, and frequent changes to the regulations for clinical trials are not uncommon. Local knowledge of each country’s regulations and close communications with the respective regulatory agencies are essential to keep up with these changes.
In every country, all key regulatory documents must be translated into the local language. Strict regulations covering the import of drug supplies and the export of biological materials, such as subject samples, are another common factor throughout the region. A partner with expertise in local customs regulations to review import documents in advance of study supply shipments and the capabilities to facilitate the local distribution can save considerable time and help avoid customs delays.


Qualified investigators:

Another important characteristic of the region is the availability of well-qualified medical professionals and investigators with clinical trial experience. Latin America has a long tradition of Western medicine. Many of the region’s physicians were trained in the United States or Europe. As a result, knowledge of International Conference on Harmonisation (ICH) guidelines is widespread, and awareness of Good Clinical Practice (GCP) standards is growing.
Sponsors will also find investigators eager to participate in clinical trials. In addition, the structure and traditions of the medical profession in Latin America give physicians more time to devote to clinical trials than their counterparts in the United States or Europe.


Growing markets:

Sponsors can also leverage their clinical trials in Latin America to gain an advantage in one of the fastest growing pharmaceutical markets in the world. Latin America represented approximately 25% of global pharmaceutical sales in 2000, and that share is expected to exceed 30% by the end of 2002.
The growing success of the pharmaceutical business in the region reflects the significant investments made in Latin America by most of the world’s major pharmaceutical companies, as well as the presence of numerous contract research organizations (CROs) like R&D and other companies that supply support services to the pharmaceutical industry. The availability of these resources in turn supports the growth of clinical trials in the region.
Latin America’s advantages as a location for clinical trials are confirmed by the hundreds of ICH-compliant trials already successfully conducted or under way in Latin America. But even with this growing popularity, tremendous untapped potential and capacity for trials exists throughout the region.


Common language:

When sponsors wish to conduct multinational trials, Latin America offers the additional advantage of a common language, Spanish, across most of the region; whit the exception of Brazil, where Portuguese is spoken.