Fighting The Logjam In LatAm Drug Trials
Clinical research in Latin America has grown significantly over the past 10 years but obstacles to continued growth still exist. In our first-ever survey of investigative sites in Latin America, we at Thomson CenterWatch found that bottlenecks at the site level continue to hinder growth of clinical research in the region as researchers strive to improve the system.
In the survey, 86% of respondents said that regulatory delays and bureaucracy were the biggest challenge to conducting clinical trials. Two of the largest markets, Brazil and Mexico, have the lengthiest and sometimes slowest moving regulatory approval systems. Both countries have said, though, that they are committed to streamlining their processes.
The six major markets—Argentina, Brazil, Chile, Colombia, Mexico and Peru—account for 425 million people, or 80% of the region’s population, equal to the population of the entire European Union but less than half the size of India or China.
As with India and China, Latin America’s major advantages are large treatment-naïve populations, centralized healthcare delivery and strong patient-physician relationships, which all lead to rapid patient enrollment in clinical trials. Only 41% of clinical trials conducted at Latin American sites have more than a one-month delay in enrollment, compared with 55% at European sites and 70% at U.S. sites, according to Thomson CenterWatch surveys.
The number of employees working for major pharmaceutical companies in the region and dedicated to clinical research has grown substantially in the past five to 10 years, though growth is expected to slow.
Bristol Myers-Squibb has 100 employees dedicated to clinical research in the region today – triple the number it had only five years ago. Novartis has 200 employees in the region in its medical departments but not all are dedicated to clinical research. The company enrolls 10 to 20 times the number of patients it did five years ago. Schering-Plough employs 89 staff dedicated to clinical research in the region and will hire an additional 30 in the next year-and-a-half.
The key to the region’s continued success will be removing unnecessary regulatory delays, which will mean increasing staff and improving training. In addition, making sure that the pool of trained physician investigators keeps pace with the increased amount of clinical research will be crucial. All outward signs point to Latin America’s hot clinical research market continuing to grow, but at a moderate pace.
Latin America has only just begun to unlock its potential as a clinical research market and could certainly provide both India and China with some formidable competition down the road.