Latin America is a geographical region with a largely untapped population for clinical trials, and it has experienced tenfold growth in clinical trials since 2000.1 However, according to clinicaltrials.gov, there are currently only approximately 3,500 studies being conducted in all of Latin America, compared with the approximate 30,000 in the United States alone.
The population of Latin America (>626 million people) is concentrated primarily in urban areas, with many lacking access to quality healthcare. As a result, I have found that clinical trials often observe rapid enrollment, with engaged and accessible patients who typically have good relationships with their physicians. My experience also indicates that the combination of qualified investigators and site adoption of ICH GCP guidelines ensures high quality standards for clinical trials.
One downside to conducting clinical trials in Latin America has been the historically lengthy timelines for regulatory approval, study budget process and contracting. Also, local insurance payers do not always cover the costs for diagnostic tools and/or ancillary drugs and devices, making this the responsibility of the sponsor.
However, progress is continuing to be made in these areas. For example, the Pacific Alliance was formed as an economic program supporting regional integration with the free movement of goods, services, resources and people. Also, the Ministry of Health in Argentina (ANMAT) issued a new regulation in April of 2017 to shorten the timeline for clinical trial approval from 160 business days to 70 days, while Argentine Customs pledged to simplify their import process for equipment and drugs.
As improvements continue to be made in these countries, partnering with a company that has long-standing experience, relationships and site networks in the region can help navigate the current lack of regulatory harmonization and stay on top of changes. Local partners assist with communication with local regulatory and customs officials, provide hands-on support with site training of the study protocol and identify local suppliers who will store, handle and transport materials appropriately. Regional variations in language within Latin America often require support with document translation.
Bioclinica has had a presence in Latin America for 14 years and has an established site network in Latin America consisting of 13 sites in six countries. We can help take advantage of the benefits of Latin America as a site for clinical research, providing early entry before others take advantage of the larger and diverse patient base.
For more information about Bioclinica, please contact me at Lauren.Chazal@bioclinica.com.