Clinical Research in Mexico: Trials and Tribulations

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According to a recent World Health Organization study, countries must allocate at least six percent of their GDP to research and development to be considered to have a healthy investment in this area. As Mexico currently only invests 1.8 percent of its GDP into R&D, there is clearly still a long road to travel. However, significant progress has been made in the past 15 years and Mexico is fast establishing itself as the clinical trials hub for Latin America, superseding Argentina, the previous incumbent, and is also developing a burgeoning network of domestic and international contract research organizations (CROs) able to meet the standards set by major international pharmaceutical and biotech players.

CROs on the Go

Ricardo Uribe, director of country operations for Mexico, Central America, and the Caribbean at global CRO heavyweight Covance, outlines the benefits of contracting research activities out to a CRO thusly; “The decision to contract research activities to a CRO is typically driven by both the quality that the sponsor will receive and the cost-saving prospect of no longer needing to hire long-term employees in-house.” Uribe also points to the fact that, in CROs, “given the level of specialization, approval rates are much faster than when trials are conducted in-house.”

“I am proud to confirm that the Mexican CRO industry now fully complies with the highest international quality standards.”

Arturo Rodríguez Jacob, President, ACROM

This outlook is backed up by Arturo Rodríguez Jacob, CEO of Infinite Clinical Research and president of the Mexican CRO association, ACROM. He asserts that “CROs are able to conduct clinical studies 30 percent quicker than those conducted in-house” and highlights how far the industry in Mexico has come from being barely existent merely 15 years ago; “I am proud to confirm that the Mexican CRO industry now fully complies with the highest international quality standards.” The establishment of ACROM has been key in this process, allowing for greater visibility for CROs in front of the Mexican state and better representation of industry interests, with the association now representing 16 multinational and local companies; 80 percent of the total CROs in the Mexican market. In addition, it collaborates in the development of more than 7,000 drugs for key therapeutic areas such as oncology and cardiovascular diseases and Rodríguez Jacob explains that “ACROM has gained a lot of weight within the industry and now it includes most of the clinical trials carried out in Mexico.”

Partnering for Progress

Collaboration and partnerships with public institutions, as well as other CROs and pharmaceutical companies, are seen by many within the clinical trials space as key to success. Ciro Garcia, CEO of Accelerium Clinical Research, explains that “in order to [increase access to larger patient populations] we will need to collaborate with CROs and pharmaceutical sponsors to increase the level of clinical research in Mexico. On one hand, we collaborate with regulatory authorities to help streamline and facilitate the authorization of clinical trials in the country, while working with the industry to integrate best practices in developing and conducting clinical studies.” Covance’s Uribe takes a similar tack, noting how his organization “strives to create preferred partnerships with some of the key institutions, especially given the fact that only 20 percent of clinical trials are conducted in the public sector. The interest to increase this rate is not only due to the fact the most profound need is in this sector, but also because conducting trials in public hospitals helps ease the entry of drugs into the ‘basic scheme’ system, wherein cost is balanced with the regulatory framework.”

For Alejandro Arias, CEO of iLS Clinical Research, greater collaboration allows CROs to better comprehend the varying needs and requirements of different stakeholders and consequently reduce the time taken and expense incurred in bringing a drug from development to market. He proclaims that “It is important to remember that companies and institutions always have an administrative infrastructure in place and at some point, bureaucracy will add time to an already complex development process such as a clinical trial. Understanding each party’s requirements and the start-up process along with being flexible helps remove barriers and reduce cycle times.”

Regulatory Reshuffling

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Increasingly stringent regulation in Mexico is impacting the entire pharmaceutical value chain, with the Mexican regulator, Cofepris, aiming to bring its standards up to a par with the US FDA and EU EMA. While this new regulation is helping to improve standards across the industry and establishing Mexico as a regional pharmaceutical leader, able to increase its exports to both developed and developing markets, it is also causing some issues for a clinical trials segment still in relative infancy. Pedro Galvis, general manager of Merck Mexico, warns that “regulators and the rest of the stakeholders should advance towards shortening the lead times in getting the approvals to start running trials in Mexico; especially considering that some companies are choosing other countries in the region such as Argentina and Peru to run their trials.”

Covance’s Uribe is less pessimistic and describes how the new regulation can improve patient outcomes: “the government now requires tighter reporting through implementing mandatory clinical trial programs at a post-market phase when the product has already been launched in the market for two to three years. The trials are purely observational and non-interventional, with the sole purpose of providing a more accessible platform for reporting. Therefore, pharmaceutical companies have a higher obligation to report adverse events through these programs and are able to attain explicit data for these matters.” Accelerium’s Garcia also sees the bright side of this paradigm shift, remembering that “Previously, clinical research could have been easily performed in a small doctor’s office, manually recording data, with barebones equipment. To keep up with quality and safety, regulators now require more complex infrastructure and controls.”

Patients are a Virtue

In terms of establishing Mexico as a regional leader for clinical trials, patient recruitment is clearly a defining factor, and one in which the country has steadily improved. Accelerium’s Garcia highlights January 2017 as a watershed moment for the industry, as “President Peña Nieto and the General Director of Mexican Social Security Institute (IMSS) announced the Institution itself would be formally engaging in clinical research, which will invariably help [to increase the volume of patients participating in clinical trials].” Merck’s Galvis has identified a positive sea change in this area, opining that “In terms of patient recruitment for local trials, we have experienced some improvements in comparison to the past and to other countries.” Galvis, however cautions that “the most difficult part in Mexico is the bureaucratic process to get the green light to actually initiate the clinical trial process.”

“Mexico has strong potential to become a clinical research leader worldwide.”

Ciro Garcia, Accelerium Clinical Research

Mexico is, in the words of Covance’s Uribe, “inherently diverse,” meaning that companies conducting clinical research have access to large concentrations of patient populations; creating “cost-efficiency, a controllable environment in terms of quality, as well as higher engagement of the patients and the investigators” according to Uribe. Furthermore, Uribe describes how, for companies with a regional rather than just a national footprint, “the sample size and diversity of patient populations is further enhanced when the focus is expanded to other countries, such as those in Central America and the Caribbean region … The variety of orphan diseases present in Central America and the Caribbean is, unfortunately, very high, therefore making it an ideal region to find patients to complete studies.”

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Why Mexico?

ACROM’s Rodríguez Jacob is clear on the Mexican clinical research industry’s plus points. He proudly proclaims that “the Mexican CRO industry now fully complies with the highest international quality standards … the clinical development process has been professionalized with a clearer role for each stakeholder … [and] the evolution of the mindset in academia and public institutions has played an important role in positioning Mexico as a hub for clinical trials within the region”

However, despite these developments, there is still a long way to go in terms of attracting more high calibre clinical projects to Mexico, as well as creating a global perception of the country as able to compete with the best in the world in terms of both costs and quality. Accelerium’s Garcia believes “that Mexico has strong potential to become a clinical research leader worldwide. We have all the elements, such as population, disease profile, ensemble of trained investigators and the local representation of the international bio-pharmaceutical and CRO industries, as well as a supporting regulatory agency, Cofepris, on par with the most recognized agencies worldwide. I’m confident that these fundamentals will eventually assimilate together in the most synergistic manner to significantly elevate the total number of active trials in the years to follow.”

Covance’s Uribe agrees, arguing that all the fundamentals are in place but that “some companies are simply not aware of the potential, talent and infrastructure that is available in the country. There are current uncertainties in terms of quality, timelines and performance of sites which can be easily mitigated through conveying a stronger communication message of the high-level results that delivered in the country.” Furthermore, “the costs of clinical trials [in Mexico, as well as other Central American and Caribbean counties] are comparatively very low and therefore clinical trials activities are very well-received. Oftentimes, the only chance for some patients to receive proper high-level care in these countries are through clinical trials,” reveals Uribe.

iLS Clinical Research’s Arias is keen to call attention to Mexico’s geographic location, describing the country as “a gateway to other Latin American countries for clinical trials.” Mexico’s burgeoning clinical trials infrastructure is now allowing iLS to expand internationally, with Arias describing how “we are now supporting Mexican clients looking to register their products in other Latin American countries such as Brazil, Colombia and Argentina.” As a final word, Arias calls for even greater collaboration throughout the clinical trials sector, opining that “Though the advantages of running clinical trials in Mexico are plenty, we need to continue working together as an industry so challenges causing variability and affecting regional credibility can be countered.”

Writer: Patrick Burton

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