The Top Reasons for conducting a Clinical Trial in Latin America.


Many, of the major South America cities were founded during the era of European Colonization. They are infused with a unique energy. Other cities are bastions of Latin America finance and banking, were glass and steel towers stand by side with the remains of a more distant historical past.

The Top Considerations for Conducting Clinical Trials in Latin America

Summary

Until recently, many in the pharmaceutical research community believed the health care systems and potential investigator pools in Latin America did not meet U.S. and European clinical trial standards. This market is now valued for time and cost efficiencies; accessible and compliant patients; and competent and enthusiastic investigators.

As with any developing region, there are challenges to conducting clinical trials in Latin America. All are readily managed with proper planning and an understanding of regulations and proper procedures.

Despite regulatory activities that may take longer than in the U.S. and Europe, clinical trial sponsors often achieve savings through faster patient enrollment. Most Latin Americans live in cities. This allows for more patients per site, easier patient follow up and less expensive travel for sponsors.

The standard of medical training in Latin America is high, and investigators are knowledgeable in Good Clinical Practice and International Conference on Harmonisation guidelines. Latin American investigators are eager to participate in research, and their involvement in site activities helps ensure patient retention.

Because sponsors with experience in the region recognize its many advantages, Latin America has become an increasingly desirable market for clinical trials.

Considerations for Conducting Clinical Trials in Latin America

Pharmaceutical, biotech & Medical Device companies that need to streamline drug development are increasingly offshoring clinical trials to emerging markets. They have discovered that some locations offer desirable efficiencies in time and expense without sacrificing quality. This paper offers an overview of the advantages of, and challenges to, conducting clinical trials in Latin America.

Within three years, up to 65% of FDA-regulated clinical trials for the top pharmaceutical companies will be conducted outside the U.S. Until recently, many in the pharmaceutical research community believed the health care systems and potential investigator pools in Latin America did not meet U.S. and European clinical trial standards.

Global Locations ESTERN Medical

The Latin American region includes Mexico, Central and South America.

Growth in Latin America’s clinical research market accelerated as these developing countries adopted regulations governing clinical research, created regulatory bodies dedicated to clinical research, formed ethics committees and adopted International Conference on Harmonisation- Good Clinical Practice standards.

Today, this market is valued for time and cost efficiencies; accessible and compliant patients; and competent and enthusiastic investigators.

Advantages of Conducting Clinical Trials in Latin America

Time and Cost Efficiencies

The greatest savings in Latin America are usually achieved through patient enrollment. Despite regulatory activities that may be longer than in the U.S. and Europe, the overall enrollment time is shorter because there are fewer trials competing for the same patients; there are more patients per site; and patients are easier to enroll than in the U.S. and Europe. In one survey, respondents reported delays longer than one month in only 41% of Latin American sites, lower than reported for Western European and U.S. sites.

For many U.S. and European sponsors, Latin American time zones are more convenient than other emerging regions.

Because the northern and southern hemispheres have opposite seasons, year-round trials on seasonal diseases can be conducted in Latin America in conjunction with North American and/or European studies.

Accessible and Compliant Patients

Latin America is one of the most diverse regions in the world. Race and ethnicity greatly vary from country to country, and people from throughout the world immigrate there in large numbers.

As a result of more sedentary lifestyles, smoking, drinking and obesity, Latin Americans’ disease patterns increasingly resemble those of the U.S. and Europe. The number of deaths from infectious diseases in Latin America is declining and mortality rates for cancer, heart disease and strokes are rising.

Other reasons to consider conducting clinical trials in Latin America include:

Population. There are approximately 500-600 million people, including a large pediatric population, across Central America, South America and the Caribbean. Up to 80% are concentrated in cities. This enables faster enrollment and easier patient follow up compared to other developing regions and it allows for simpler, less expensive travel for sponsors. Because so many are treatment and trial naïve, a high proportion of patients have not had exposure to medications that could interfere with clinical trial drugs.

Language is not a barrier. English is widely spoken within the clinical research community. Spanish is the predominant language in the majority of Latin American countries, and Portuguese is spoken primarily in Brazil, the most populous country in the region. This is the only region of the world of such size with so few languages.

Patients are motivated to participate. Clinical trials offer access to innovative new pharma-drugs & medical devices they could not otherwise obtain. “We think clinical research in Latin America is something that helps the industry because they need to have patients, but the greater need is for patients to have good treatment,”

High patient retention rates. Patients tend to comply with study requirements because they appreciate the structured, accessible care.

Competent and Enthusiastic Investigators

The quality of the data collected in Latin American clinical trials is comparable to that of data collected in the U.S. and Europe. This is due, in large part, to the quality of the investigators, who are knowledgeable in Good Clinical Practice and International Conference on Harmonization guidelines.

Physicians in this region tend to develop strong relationships with their patients. In some of the countries, patients go to the same hospital from birth to death. Most investigators conduct clinical trials in government sponsored academic institutions with large captive patient populations.

Latin America has a long tradition of Western medicine and the standard of medical training is generally high. Many physicians in this region have been trained in Europe or the U.S. The level of investigator involvement in site activities is a particular strength. Latin American investigators are eager to participate in research which contributes to their excellent patient retention rates.

Challenges to Conducting Clinical Trials in Latin America

The rapid growth in Latin American clinical trials has created increasing competition for patients and investigators. Although there is a large patient population in each city, there are a limited number of sites. Therefore, it is important to continue developing more sites with good clinical researchers.

Here are other challenges to consider:

Investigators’ support staff is key to success. Because Latin American physicians who run clinical trials also see regular patients at their clinics, sponsors should seek the best investigators who have staff capable of helping run the study.

Rigid regulatory environment can cause delays.

Regulations vary among the countries and different country-specific procedures are needed to authorize a clinical trial. The two main requirements are regulatory authorization and ethics committee approval. In some countries, sponsors can pursue both simultaneously; in others, there is a sequential approval process.

The regulatory approval process takes approximately three to six months. Sponsors who do not know how to navigate each country’s system may experience longer timelines. Also, in many countries, it is difficult to obtain approvals for studies that include placebos. Establishing good relationships with regulatory authorities is key to shortening clinical development and approval times (reference Figure 1).

Figure 1: Regulatory Timelines in Latin America

no,

Import/export procedures can seem daunting. A drug import permit is required and the process is fairly complex. Although some sponsors are concerned about shipping drugs to Latin America because they are not familiar with the process, this is not a problem for someone who understands and complies with local regulations.

Some sites lack good infrastructure for electronic data capture. This is an issue in many developing countries. It is important to ensure that appropriate systems are in place prior to study startup.

Requirements for informed consent forms (ICFs) can be stringent. Sponsors who do not understand local requirements often run into problems with ICFs. The forms must be customized to meet regulations in each country. ICFs for trials that involve complex medical procedures are especially demanding; regulators expect them to be understandable to patients of all education levels. Therefore, forms should be prepared in simple language.

Some studies raise cultural issues. Sponsors must understand the culture before planning a trial in Latin America. For instance, most of the region’s population is Catholic, therefore, some elements that may be required by a trial – such as information about sexual behavior – are considered inappropriate and could cause a study application to be rejected. Sponsors are advised to research a country’s taboos prior to submitting a study application.

Industry experts recommend that pharmaceutical and biotech companies interested in sponsoring clinical trials in the region seek a partner with expertise in navigating the local regulatory, medical and cultural climate. Sponsors who invest time in appropriate preparation and resources usually discover they can conduct quality clinical trials more efficiently in Latin America.

Key References:

1. Outlook 2008. Tufts Center for the Study of Drug Development.
2. Gambrill, Sara. Hot Latin American Clinical Research Market Will Moderate. The Center Watch Monthly.