Going Global To Latin America

By: Mary Jo Lamberti APC

References Mary Jo Lamberti,* PhD, Thomson CenterWatch & Sara Gambrill is senior editor with Thomson CenterWatch & The World Book Fact Book, CIA

Driven by dynamic regulatory reform, clinical trials in ascending markets are on the increase in Latin America. Driven by dynamic regulatory reform, clinical trials in ascending markets are on the increase in Latin America.

Clinical trials in developing nations-called "ascending markets"-are exploding. These regions offer large naïve subject populations, low operating costs, and increasingly stable testing infrastructures, but regulatory reform is really driving the growth. CenterWatch data show 20%–30% of clinical trials are being conducted in ascending regions.

The three major ascending regions are, Latin America, Eastern Europe and Asia. When considering trial placement, sponsors need to begin by asking two critical questions: Does the sponsor company itself have a local affiliate in the area? Can I be assured of performance quality? At issue is the need for assurance that the study will be started quickly, that the logistics of the study will run smoothly, and that overall, the study conduct activities will be managed as effectively as possible with high site quality.

Other selection criteria include the region's ethical review quality and regulatory restrictiveness. Notably, availability of study subjects is not a differentiating criterion among ascending markets, as abundant and treatment-naïve subject populations exist in all ascending regions.

Latin America

Latin America has the most ground to make up in order to become an attractive ascending market. Better, faster investigator training is critical in Latin America. Compounding the quality issue are minor problems. Many site workers do speak sufficient fluent English to complete CRFs. "There is constant translation of documents-both in terms of official submissions to IRBs plus the regular, day-to-day communication," said one sponsor. "We have to act as a bridge with communications."

A critical need for jobs and the attractiveness of site employment may ultimately solve these problems. "Clinical research is being taken seriously in Latin America," observes one sponsor. Sites that leverage the ample labor supply by providing critical training have a distinct advantage. Some sponsors caution, though, that operating in Latin America is not as cheap as it may seem. Savings in subject recruitment can be easily gobbled up by importing/exporting fees and other costs.

Mexico, Argentina, Colombia and Brazil provide the region's major markets (see Figure 4). Smaller Latin American countries with relatively stable sociopolitical climates have been very successful as well. Costa Rica, Chile, and Peru offer investigators eager for work and study approval processes that are simple and fast.

Most research conducted in Latin American countries comprises Phases III and IV, with Phase I and II studies increasing. Common disease states studied include infectious disease, oncology, rheumatology, dermatology, cardiovascular, and CNS. Latin America in particular has shown expertise in conducting oncology and infections disease trials, as well as with AIDS and dermatology studies.

Sociopolitical issues.

Sociopolitical issues come with the territory in Latin America. How they affect trials can vary. An executive at an international CRO said, "There is stability in the Latin American sociopolitical system, so you need to have a contingency plan when you operate in the region." Mexico, Colombia, Chile and Argentina, the region's largest market, recently saw upheaval in its government. A recent shift of political power in Brazil rippled to the Ministry of Health, resulting in additional delays in the already difficult approval process. Sponsors are facing indefinite delays in Venezuela while the country grapples with widespread social and political unrest. Colombia offers substantial opportunity with a large population and high-quality sites and facilities.

Regulatory issues.

Approval times can range from four to six months in Latin America. Mexico, Chile, Colombia and Argentina, widely considered most advanced among its neighbors in terms of regulations, nonetheless requires sites to seek approval through a cumbersome, multistep process.

Brazil, Latin America's largest and most populous country and the region's leading economic power, poses the most problematic regulatory environment in Latin America. Customs laws in Brazil are complex, and importing/exporting is costly. Additionally, Brazilian ethics committees can be highly restrictive.

A local staff person is considered one key success factor in negotiating Latin American countries. As one sponsor commented: "The main reasons why clinical trials fail are lack of local knowledge and lack of understanding of the customs of the country...You need to have a local person in each country."

Latin America holds a great deal of potential for the clinical trials industry.

Looking ahead

Each of these ascending markets shows unique promise for sponsors seeking large naïve subject populations and adequate to excellent site quality.

Latin America sites are ahead of the game in terms of overall competency

Regulatory hurdles will continue to challenge sponsors and the sites with which they partner. Where possible, sponsors should seek to influence regulatory and legislative changes advantageous to clinical trials, particularly those that encourage ICH-GCP compliance, shortened protocol approval times, and improved patent protections. Meanwhile, management in ascending regions should concentrate on understanding how to best negotiate local bureaucracies through better collaboration with authorities, and on contracting with local, native workers who can facilitate communications.

Sponsors should also realize they are bringing significant economic advantages to ascending regions. Training workers in critical investigative skills can result in higher site quality and a more stable clinical trials infrastructure. This is especially true in Latin America.

Finally, sponsors should bear in mind that they are not alone in their impatience to westernize developing countries' business cultures. Executives should keep an eye fixed on the future, realizing the inconveniences of today are the cost of doing business in an area where opportunity is unprecedented.

Data for this article were collected through 21 in-depth interviews with individuals from biopharmaceutical companies, CROs, regulatory agencies, and health ministries.

The individuals interviewed had expertise in conducting trials in Latin America.