Latin America is globally recognized for its enrollment potential and the high quality of study data obtained. In addition, regulatory enforcement bodies, quality investigators, ethics committees ensuring patient safety, proactive Good Clinical Practice (GCP) policy development, and large research naïve populations have been cited as contributing to the explosive growth of clinical trial management in this region.
For example, the number of clinical trials started in Brazil increased 58% (from 153 in 2005, to 241 by 2009). In Argentina the growth in new trial starts was more modest at 16% (from 97 to 112 over the same period), while Mexico achieved a 49% increase in new trial starts (from 106 to 158 over the same period).
Ensuring the success of Latin American trials
Successful clinical trials rely on a variety of factors, including:
- Willing target population. An advantage of Latin America is that it has densely populated areas, with an increased likelihood that many people will meet prerequisites for a clinical trial. Latin American countries also offer a wide ethnic diversity, due to significant immigration from Europe, Asia and Africa. The doctor/patient relationship among Latin Americans is very strong, leading to a high level of willingness to participate, compliance and retention throughout the course of a clinical trial.
- Investigational teams. One of the most important factors in conducting a successful trial is the quality and enthusiasm of the investigators. Many investigators place a high value on the scientific and academic aspects of the trial, and are pleased when they are invited to participate. Growth has led to proliferation of educational forums where investigators are schooled in all aspects of clinical research. Regulatory authorities often require that investigators, study coordinators and nurses take certain courses and that physicians proposed as principal investigators are certified. All take the need for rigorous procedures and high quality very seriously.
- Epidemiologic considerations. As with any clinical trial, it is important to understand the epidemiologic features of a region before locating a study there. Ethnic and genetic predispositions both play a role in the frequency and incidences of certain types of diseases. Seasonal diseases like pneumonia and flu occur at different times of year in the southern hemisphere, making Latin America a well suited region to conduct infectious disease studies, with a seasonal component so that manufactures don’t have to wait to conduct their trials.
- Health systems. Health systems vary from country to country, but most have a distinction between public and private institutions. Either type can conduct clinical trials, although there are going to be epidemiological, social and cultural differences in the type of population being assisted. These factors will be relevant when performing site selection in connection with a specific clinical trial.
- Standard of care. The standard of care for different pathologies and procedures is about the same as that found in the US or Europe. It is possible to both find patients who have been on a prerequisite treatment and to find those that are “treatment naïve.”
Navigating regulatory challenges in Latin America
Latin American countries have become desirable sites for studies both because they have adopted regulations that mirror those recommended by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and because the regulatory authorities are committed to keeping them updated.
In Brazil, the National Committee for Ethics in Research (CONEP) provides the main ethical approval for clinical trials with foreign cooperation. The designated lead research site submits the study protocol and informed consent to CONEP. In parallel, the sponsor submits the trial for review and approval by the Ministry of Health.
Argentina also requires that a study must obtain institutional approval and approval from the local representatives of the Ministry of Health. In Chile, only IRB approval is required. While the Ministry of Health does not have to approve the study, they do acknowledge the study and issue the import license for drugs connected with the trial.
Best practices lead to better outcomes
- On planning: Don’t underestimate the length of time it will take to go through the international regulatory and import process. You must also plan for time to establish an internationally legalized power of attorney and regional localization.
- On process: Due to the nature of the regulatory process in Latin American countries and the cycle time to trial approval it is vital to submit documentation correctly the first time. It may help to have a checklist for sponsors so they understand the detailed documents that must be provided for the local and national regulatory packages.
- On communication: Take time to understand how the sponsor’s representatives like to work and what they prefer as a communication channel, especially when considering language and culture differences. Invite sponsors to come and visit potential sites – face-to-face meetings are a great tool for building understanding and a sense of cooperation. Seeing the facility, talking to the investigators and staff are great ways to learn more about how things are being conducted.
- On culture: It is particularly important to have someone local involved with the trial who understands and can address regional issues and how cultural differences could affect participation. Patients’ willingness to participate under certain conditions is often connected to their level of education and values, which might vary regionally.
- On respect: To be successful in Latin America one must have an authentic respect for culture, custom and language. Local resources will likely have a greater understanding of this than study sponsors. For example, local managers understand specifically what the ethical boards are looking for in the informed consents and have developed templates.