Clinical Trials In Latin America - White Paper


Author: Darren Kline Director

Refs: CenterWatch, PhRMA, IMS-Health & APC

Synopsis

In the past, few clinical trials were performed in Latin America because of a perception that the region’s healthcare systems and potential investigator pools were not up to the standards used in North American and Western European trials. This view has changed substantially in recent years as Latin American governments have improved healthcare and related regulations. These investments and changes have paid off as more and more Latin American physicians are becoming involved in studies that comply with GCP and ICH standards.

Analysis of clinical study trends shows that the top Latin American markets of Mexico, Chile, Colombia and Argentina have seen a 1000 percent increase in clinical trials between 1995 and 2008. This article expands the analysis to show that Latin American trials offer superior recruitment potential and support higher local

Latin America

Latin America consists of the large South American subcontinent with its 21 countries as well as Central America and the countries of the Caribbean. Within this geography are 569 million people who can for the most part be categorized as treatment naïve (not on other medications that could interfere with experimental treatments). They can also be categorized as trial naïve—this massive source of potential trial subjects is largely untapped. Heart disease, arthritis, cancer, and infections are as prevalent as in the United States. Many of the seasonal disease states occur six months out of phase with North America, which permits year round recruiting in trials of seasonal ailments by combining Latin American with North American subjects.

In addition, this potential trial-subject population is in large part located in several major cities, allowing recruitment via hundreds of multi-center sites in several countries at the same time. According to CenterWatch, many Latin American investigators have access to thousands of patients, and a single metropolitan area in Latin America can have more than six to nine million patients within a 20-mile radius of the central urban hub. Since many of these patients fall into lower income brackets, participation in a clinical trial could often times provide them a better quality of treatment than they would get under normal circumstances.

Conducting Trials in Latin America

Latin American investigators are enthusiastic about participating in research and have excellent patient retention. “Drop-out rates in the region are about half of what you see elsewhere.” Based on a 10-site study conducted by CenterWatch, investigative sites in Latin America have on average seven years of experience in clinical research and conduct approximately two trials per year. As investigators increase in proficiency and improve standards of operation, so too are some individual Latin American governments becoming more formalized in their handling of clinical research. They recognize the potential benefit to their countries by participating in clinical trials, and are preparing to realize that benefit in coming years. The five largest markets—Mexico, Chile, Colombia, Argentina and Brazil-- are the most established in conducting clinical trials and have enacted clear controlling processes and relevant legislation All five of these countries require authorization of clinical trials by ethics committees and regulatory authorities, and the approval process spans two to four months on average.

Growth in Latin America

According to an analysis done by researchers the number of 1572 forms submitted for U.S. based trials executed in Latin America increased over tenfold from 1995 to 2008, with the yearly totals for the five largest markets increasing dramatically (in some cases well over 1000 percent) from 1995.

The number of clinical trials in Latin America is increasing at a faster rate than other geographies. Latin America has become the second largest clinical trials market and has gained on Canada (3rd largest market) dramatically over the past 5 years (1572s submitted for Latin America were 10% of that of Canada in 1995, by 2008 the same ratio grew to 63%).

Last year according to Clinical Trials Gov, more than 948 clinical trials were begun in Mexico and the number of ongoing trials in Chile is estimated at over 432. During the first eight months of 2008, Colombia received 268 new trial applications from the U.S. and Europe. According to industry observers, providing market conditions are favorable, an increase of as much as tenfold can be expected over the next five years.

This growth is reflected by the appearance of several CROs in the region. In the past few years, have opened offices in Latin America to help support their efforts in this area. With the expected expansion of the number of trials clearly indicating a corresponding need for expanded infrastructure, other CROs can be expected to respond by starting operations or opening offices in Latin America.

A Growing Latin American Pharmaceutical Market

The large Latin American population not only offers an untapped source of patients as a powerful draw to companies for starting trials in Latin America, but it also creates impressive market potential for pharmaceutical drugs-- another justification for entry into this new market. Three of the top 15 largest pharmaceutical markets can be found in Latin America. Yet, despite a population almost twice the size of that of the U. S., the Latin American ethical pharmaceutical market is less than 20% of the size of the same market in the U. S. Further analysis reveals that the Latin American market share for ethical pharmaceuticals from researched-based pharmaceutical companies (excluding the United States) is 11.52% of the total or approximately $4.7 billion.

Of this overall sales figure, the top three growing markets in Latin America are Mexico, Brazil, Colombia and Argentina, respectively, which also show the largest growth in trial activity over the past 5 years.

According to IMS Health, by 2010 Mexico, Brazil, Colombia and Argentina will account for over 81% of the overall Latin American market for pharmaceutical sales, with Mexico overtaking Brazil as the largest single Latin American market (Mexico’s growing economic strength in NAFTA (North American Free Trade Agreement) and recent moves by the Mexican government to expand healthcare are cited as the reasons for this gain) If the view is expanded to the seven largest Latin American pharmaceutical markets, the Compound Annual Growth Rate of the combined market is expected to be 7.3% per year on average, spurred in part by new product patent-protection regulation and enforcement, which makes the region more appealing to multinational companies. Despite this swelling volume of sales, however, Research and Development spending in Latin America by PhRMA (Pharmaceutical Research and Manufacturers of America) is only 1.6% of total global R&D expenditures, or $78.5 million. This is the fourth largest spend but almost an order of magnitude smaller than the top three geographical areas.

Trials and Increased Sales

Recent studies conducted by researchers have demonstrated that investigators who participate in clinical studies subsequently prescribe the drug studied more frequently on an ongoing basis. This study used a matched case/control analysis of 3431 Phase III and Phase IV investigator sites. involving 2596 unique investigators and 2596 control physicians from the IMS prescriber database. By examining trials at these sites from seven indication groups (asthma and allergic rhinitis, hypertension, osteo- and rheumatoid arthritis, depression, pneumonia, hypercholesterolemia and diabetes), Researchers were able to statistically prove that trialists prescribe the study drug at significantly higher rates than do control physicians.

These statistically significant differences hold whether the drug is novel or not, or reaches a high market share or not; and whether the physician is board certified or not, or is a high prescriber of the sponsor company’s drugs before the study commences. Since the market potential is high and growing in Latin America, it can be inferred that those companies that begin to conduct more trials in Latin America will also be positioned to benefit from increased investigator brand awareness with an increased likelihood of investigators prescribing products produced by sponsors of trials in which the investigator has participated.