Clinical Trial Go Global


Next Stop, Latin America

Ref. Pharma, July - August 2009, Vol 5 Num 4.

By 2012, more than 65% of FDA-regulated clinical trials for leading pharmaceutical companies will be conducted outside of the United States. Where to conduct clinical trials can depend on many criteria, including the location of corporate global facilities, costs, regulations and future product launches. More and more, emerging market regions are being considered because they offer significant market potential (pharmaceutical growth in the United States in 2009 is projected to be 4-5% whereas, in emerging market regions, it is projected to be 14-15% for 2009) without compromising the quality of the trials.

One increasingly important emerging market region is Latin America, which is popular because the region has established regulatory bodies that are tasked with the development and enforcement of guidelines for clinical research, and the formation of ethics committees to make sure patient safety and ethical concerns are top priorities. Latin America has also proactively developed policies that adhere to the International Conference on Harmonization (ICH) guidelines on Good Clinical Practice (GCP). Latin America encompasses Mexico, most of Central and South America, Cuba, the Dominican Republic and Puerto Rico. The World Factbook indicates that 569 million people reside in this region. The population offers good potential trial subjects because large parts of the population have not been exposed to, nor are they currently taking, medications that may interfere with a trial drug; in other words, there is a large population of treatment- or trial-naïve people. An additional reason why Latin America represents potentially good subject candidates is because “lifestyle” disease profiles increasingly resemble those of the United States and Europe; diseases such as obesity, heart disease and cancer are on the rise.

Of the total pharmaceutical market in Latin America, Mexico, Brazil and Argentina (37.4%, 28.4%, 15.3% market share as a percentage of the total pharmaceutical market, respectively) have seen the most clinical trials. These countries have more advanced regulatory guidelines and streamlined trials approval processes. Their track records of approval times are approximately 4–6 months from the time the final protocol is translated into Spanish and/or Portuguese — a significant improvement on the trial approval time in the United States or Europe (6–12 months). However, although the trial approval timeline may be shorter, the overall drug approval timeline may be longer with Latin American approvals agencies.

  Total Number of Clinical trials Registered with ClinicalTrials.gov Total Number of Medical Device- Specific Trials Registered with ClinicalTrials.gov
US 39,040 2,705
EU

16,360

1,451
Canada 5,696 410
Asia (China, Hong Kong, Republic of Taiwan, South Korea) 4,171 178
Latin America 2,933 108
Middle East 2,454 260
Australia 2,201 131
Figure 1: Data from ClinicalTrials.gov (29 March 2009).

Regulations for Clinical Trials

Although many of the regions in Latin America have regulations governing the requirements for how clinical trials should be conducted, in a few cases, regulations have not been put into practice or enforced because they are either newly minted and have not yet been put to the test (Guatemala) or the regions lack the resources to finalize the regulatory process (El Salvador and Uruguay). Furthermore, the regulatory guidelines often leave room for interpretation, which can make it hard to determine compliance. Larger countries such as Argentina, Brazil and Mexico have more advanced infrastructures, but the smaller countries are still developing and implementing their regulatory systems. Therefore, before embarking on a clinical trial campaign in Latin America, it is imperative to know the current status of the country’s regulations.

Latin Fever

Many companies have been attracted to Latin America for clinical trials because the population (77% of all people in Latin America) is clustered around urban areas. This makes it easier to recruit and retain patients, reducing the time to last patient enrolled, as well as reducing operating costs at live trial sites. One recent CenterWatch survey estimated that clinical trials in Latin America have fewer delays than the United States or Europe. Delays of one month in Latin America accounted for 41 % of trials, whereas the figure is 55% of US trials and 77% of EU trials. The favorable patient recruitment and retention environment ultimately accelerates time to product launch, saving sponsor companies $1–3 million in direct costs and opportunity losses per day if a drug is not delayed to market. With a combined population of almost 60 million — representing about 10% of all Latin America — the four cities of Mexico City, São Paulo, Buenos Aires and Rio de Janeiro have become ideal places for sponsor companies to conduct clinical trials.

Keys to Success

One key factor to a successful clinical trial campaign is to establish good relationships with investigators and coordinators. The best are well respected in their communities, have a good understanding of the clinical guidelines and are trusted by patients.

After approval of a product, investigators typically become the first prescribers of the new drug, saving sponsors time and money on marketing efforts. Another key to success is to establish good relationships with regulatory authorities that can help to clarify and provide quicker responses to enquiries regarding guidelines, resulting in shorter clinical development and approval timelines. In Latin America, the presence of established pharmaceutical companies (Abbott, AstraZeneca, Baxter, GlaxoSmithKline, Roche) and Contract Research Organizations, low to moderate generics penetration, spending of 4–9% of GDP on healthcare coming up to par with the 10% spent by more developed countries, and the possibility to conduct year-round clinical trials (owing to seasonal differences between the northern and southern hemispheres) point to the region as a viable place to conduct clinical trials.