Regulatory enforcement bodies, quality investigators, ethics committees ensuring patient safety, proactive Good Clinical Practice (GCP) policy development, and, of course, huge research naïve populations have been cited as contributing to the explosive growth of clinical trial management in this region. Yet, as in many regions, important challenges remain, including language and cultural barriers.
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 investigators place a high value on the scientific and academic aspects of the trial, and are pleased when they are invited to participate.
However, don’t mistake enthusiasm or novelty for inexperience. As Latin America became recognized for its enrollment potential, the number of clinical trials started in the three largest countries in the region increased significantly over the past 5 years. In mining the clinicaltrial.gov database we found 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).
Here are five tips to help you to conduct a successful trial 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 .
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 a 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.
(The following post is an excerpt from our white paper – Global Clinical Research Trials: Benefits and Challenges to Taking Trials to Latin America)