Clinipace Worldwide in Latin America

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Latin America is Fertile Ground for Clinical Trials: What Every Sponsor Needs to Know
Register for this informative webcast as we share some of our observations on challenges, the changing regulatory environment, navigating the region, and best practices and lessons learned on how to conduct successful trials in Latin America.
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Working for you in Latin America

Latin America is fertile ground for clinical trials, and Clinipace Worldwide has the staff and experience to help you activate sites, enroll patients, and ensure patient safety and the collection of high quality clinical data. As a full-service CRO, we provide local country managers, medical directors, and monitoring teams; all reporting into the global project director.

As Latin America became recognized for its enrollment potential and the high quality of the data obtained, the number of clinical trials started in the three largest countries in the region increased significantly over the past 5 years.

For example, the number of clinical trials started in Brazil has increased 58% (from 153 in 2005, to 241 by 2009). In Argentina the growth in new trial starts is more modest at 16% (from 97 to 112 over the same period), while Mexico has achieved a 49% increase in new trial starts (from 106 to 158 over the same period).
Source: clinicaltrial.gov

Latin American countries have become desirable sites for studies both because they have adopted regulations that mirror those recommended by the ICH and because the regulatory authorities are committed to keeping them updated.

Just as in politics and healthcare, clinical trials are local

Finding the right CRO partner can make all the difference, and we know how to navigate throughout the region.

In Latin American countries there are differences in the way the Ethical Committees work; in some the function of the IRB is frequently fulfilled by a national ethics review board. However, there may also be local boards that must provide approval as well.

Specifically 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.

Successful clinical trials rely on a variety of factors

Investigational Teams
One of the most important factors in conducting a successful trial is the quality and enthusiasm of the investigators. Because clinical trials are relatively new in Latin America — within the past 20 to 30 years — investigators tend to treat participation in clinical trials as more novel and interesting than their counterparts in other countries where trials have been occurring for a longer period of time. Many of these highly-trained physicians have been involved in previous trials and place a high value on the scientific and academic aspects of the trial. Without exception, all take the need for rigorous procedures and quality very seriously.

Target Patient Population
An advantage of Latin America is that it has densely populated areas, with an increased likelihood that many people will meet the prerequisites for the trial. The greater metropolitan areas of cities like São Paulo (11 million), Rio de Janeiro (5 million), Buenos Aires (13.4 million) and Mexico City (21 million) provide ready access to a broad range of study participants. Latin American countries also offer a wide ethnic diversity, due to significant immigration from Europe, Asia and Africa.

Patient Retention and Compliance
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.

Standard of Care
The standard of care for different pathologies and procedures is about the same as that found in the US or Europe; new drugs are commercially available in most Latin American countries, although they may not be affordable for all segments of the population. This makes it possible both to find patients who have been on a prerequisite treatment and to find those that are “treatment naïve.”

Considerations for conducting trials in Latin America

On planning: Don’t underestimate the length of time it will take to go through the regulatory and import process. Particularly in Brazil, it takes longer to start than in other countries. However, changes put in place in beginning in December 2009 have reduced the review timeline process by about 6 to 8 weeks.

Additionally, you must plan for:

  • establishing an internationally legalized power of attorney
  • time needed for 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. Take the time to thoroughly review all documents two or three times to avoid mistakes. It may also 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. The use of email should be carefully considered with respect to language and culture differences. Email is a powerful tool, but can also lead to misunderstandings, so it is important to pick up the phone often to ensure clarity on important issues. This ensures that misunderstandings don’t spiral out of control and also contributes to a positive working relationship.

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. For example, patients must clearly understand that they may not receive a direct benefit, and that their participation in the study is to further the cause of science and knowledge of the disease. Their willingness to participate under these conditions is connected to their 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 when conducting global trials. Local resources will likely have a greater understanding of this than study sponsors. For example, the local managers understand specifically what the ethical boards are looking for in the informed consents and have developed templates. Sponsors that have insisted on their own wording in the ICF have often had those forms rejected, thereby slowing the entire process.