What Must Mexico Do to Become a Clinical Research Hub?Wed, 09/06/2017 - 12:21
Mexico has a strategic geographical location, a large and diverse population and competitive operational costs — all the essential elements to become a global hub for clinical research. In addition, in early 2017, President Peña Nieto signed a collaboration agreement with IMSS, COFEPRIS, CANIFARMA, SAT, ANAFAM and AMIIF to promote the development of health research protocols. A greater appreciation of these tools could increase national investment in research and attract international companies. Mexico Health Review spoke with three CROs about the best strategies that can help Mexico become an international hub for clinical research.
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 the support of COFEPRIS and the most recognized agencies worldwide. However, we need to assimilate all the elements together in the most synergistic manner to significantly elevate the total number of the active trials in the coming years. Research sites should orient their activities to quality and performance to attract more research projects. Mexico accounts for less than 1 percent of all clinical research worldwide, a very low rate compared to other countries.
IMSS now allows clinical studies, which will provide great opportunities for the sector. The institution has a huge population of patients and is also a good source of patients with rare diseases that are hard to find in other institutions. In addition, Mexico has a lot of potential in pediatric clinical studies due to the large population of children and the good relationship between doctors and parents we have identified in previous recruitments. Therefore, ICON has already developed expertise in pediatric studies.We have a close relationship with patientrecruitment sites and provide quality training to professionals at each institution so they can understand their target population. We perform a close follow-up and we ensure we choose the right sites through a site selection system.
Mexico has long wait times, but not as long as other Latin American countries. In Mexico, in line with FDA rules, if an efficient rescue medicine is available, trials can be held with groups taking placebos. Mexico’s main obstacle was that it did not have access to public hospitals, whereas in 2016 and 2017 an agreement was reached with IMSS and COFEPRIS to open the doors to clinical research. The same will happen with ISSSTE and other public institutions. This dramatically increases our chances of recruiting patients. In 2016, 80 percent of trials were carried out in private institutions. We hope to attract more trials to Mexico, maintaining the amount carried out in the private sector but increasing the amount in the public sector to achieve a 50/50 balance.