Research Article by: Dr. Jorge Estrella MD, President & Chief Medical Officer at ESTERN Medical CRO Life Sciences
Within the past years, up to 78% of FDA-regulated clinical trials for the top pharmaceutical & medical device companies are conducted outside the U.S.
Not long ago many Biotech’s, Pharmaceutical & Medical Device research community believed the health care systems and potential investigator in Latin America did not meet U.S. and European clinical trial standards. Todays this R&D clinical trials market is now valued for time and cost efficiencies, accessible, broad patient populations, competent and experience, & enthusiastic clinical investigators.
As with any developing region, there are challenges conducting clinical trials in Latin America. All are readily managed with proper planning and an understanding of clinical regulations and proper EC/IRB’s & MoH’s in country procedures. Despite regulatory activities that might take longer than in the U.S. and Europe, clinical trial sponsors often achieve financial savings through faster patient enrollment in most Latin American cities. This allows for more patients per hospital site, easier patient follow up and less logistics travel for clinical trial sponsors.
The standard of clinicians or physicians medical training in Latin America is superbly high, and investigators are very knowledgeable in Good Clinical Practice (GCPs) and International Conference on Harmonization guidelines (ICHs). Latin American investigators are keen to participate in research and their involvement in site activities helps ensure patient retention and quality of R&D Data.
A great number of international R&D sponsors with experience in the LATAM region recognize of its many clinical trial indications advantages. Latin America has become an increasingly desirable market for clinical trials in all clinical trials development phases.
Biotech’s, Pharmaceutical & Medical Device companies that need to streamline R&D are increasingly offshoring clinical trials to the Latin American emerging markets. They have discovered that some geographic locations offer desirable efficiencies in time and expense without sacrificing top R&D data quality.
This article offers an overview of the advantages and challenges in conducting clinical trials in Latin America.
Advantages of Conducting Clinical Trials in Latin America
Time and Cost Efficiencies
The greatest time & savings in Latin America are usually achieved through trial patient enrollment. Despite regulatory activities that might be longer than in the U.S. or Europe, the overall patient enrollment time is shorter because there are fewer trials competing for the same patients or indication; there are more patients per site; and patients are easier to enroll than in the U.S. or Europe.
For many U.S. and European sponsors, Latin American time zones are more convenient than other global 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.
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 population numbers.
Accessible and Compliant Patients
As a result of more sedentary lifestyles, smoking, drinking and obesity, Latin Americans disease patterns increasingly resembling those of the U.S. and Europe.
The number of deaths from infectious diseases in Latin America did decline in 2019; and according to the PAHO & WHO, as of May/2021 Latin America and the Caribbean has had increment of infectious diseases due to COVID-19. Other treatment indications are also in the increment rates for oncological, cardiovascular, CNS diseases and others that are rising rapidly.
Other reasons to consider conducting clinical trials in Latin America include:
- The LATAM Population. There are approximately 670 million people, including a large pediatric population across North & Central America, South America, and the Caribbean. The key top countries are Brazil, Mexico, Colombia, Argentina, Peru and Chile.
The Latin American population is 80% mostly concentrated in major cities. This enables faster enrollment and easier patient follow-up compared to other emerging or developing regions, this allows for simpler, less expensive travel for sponsors.
High proportion of patients have not had exposure to treatment medications that could interfere with clinical trial studies
- Language is not a barrier. English is widely spoken within the clinical scientific research community. Spanish is the predominant language in most 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 fewer languages.
- Patients are driven to participate in Clinical trials as they offer access to novel pharma-drugs & medical devices that they could not otherwise be obtain in a healthcare treatment.
- 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 according to the US-FDA & EU-EMA. This is due, in large part, to the quality of the investigators, who are knowledgeable in Good Clinical Practices (GCPs) and International Conference on Harmonization guidelines (ICHs).
Physicians in the LATAM 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 clinical 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 very high. Many physicians in this region have been trained in US & Europe. 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 the Latin American clinical trials has created increasing competition for patients and investigators. Although there is a large patient population in each city, there are great number of sites either public or private medical institutions.
Therefore, it is important to continue developing more clinical sites with good clinical researchers to expand the LATAM region.
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 research staff capable of helping run support the study.
- Rigid regulatory environment can cause delays. Regulations vary among the Latin American countries and different country-specific procedures are needed to authorize a clinical trial approval and execution. The two main requirements are Ministry of Health (MoH’s) regulatory authorization and ethics committee approvals (EC/IRBs). In some countries, sponsors can pursue both simultaneously; in others, there is a sequential approval process. The regulatory approval process takes weeks or months. Sponsors who do not know how to navigate each country’s system may experience longer timelines.
- Import/export procedures can seem daunting. A drug import permit is required, and the process is complex. Although some sponsors are concerned about shipping Pharma or Medical Device into 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 (EDC). 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 country 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 Biotech’s, Pharmaceutical & Medical Device companies interested in sponsoring or executing a clinical trial in the region seek a Clinical Research Organization (CRO) partner with expertise in navigating the local regulatory, medical, and cultural climate. Sponsors who invest time in appropriate preparation and knowledge resources usually discover they can conduct quality clinical trials more efficiently in Latin America.
References:
- Tufts Center for the Study of Drug Development.
- US-FDA
- EU-EMA
- Center Watch
- Pan-American Health Care Organization (PAHO)
- World Health Organization (WHO)
- ESTERN Medical CRO Life Sciences
