A Voice To Strengthen Mexico’s Position in Clinical ResearchWed, 09/05/2018 - 14:29
Q: How can the Association of Professionals Specialized in Clinical Research (APEIC) help to improve clinical research in Mexico?
A: We are collaborating with other associations, such as CANIFARMA, AMIIF, the CRO’s Alliance of Mexico (ACROM), the Association of Physicians of the Pharmaceutical Industry (AMIFAC), the Mexican Association of Professionals in Sanitary Regulation Responsible (AMEPRES) and the Mexican Association of Pharmacovigilance (AMFV) to create events related to clinical research. In general, we follow the criteria set by TransCelerate, a globallyrecognized pharma organization.
Q: What values does APEIC represent for the industry?
A: APEIC provides a voice to everyone involved in clinical trials. We have three objectives: increase the number of professionals working in the sector, bring together all interested parties to increase our global competitiveness and spread the message and promote Mexican clinical research locally and internationally. APEIC brings together all professionals and associations that perform clinical research and related activities.
Q: What are the main barriers for scientists and doctors wanting to begin clinical research studies?
A: Researchers must be open to learn highly advanced Good Clinical Practices (GCPs) and Good Documentation Practices (GDPs). The sector is highly regulated and undergoes constant audits, so researchers must adhere to a large number of national and international regulations.
Requirements to perform clinical trials are extensive, so companies prefer to work with experienced centers that have good facilities, strong ethical committees and qualified teams. The association’s goal is to increase the number of centers in Mexico that meet these criteria. Together with the regulatory authority in Mexico and the Autonomous University of Nuevo Leon (UANL), we are generating a national registry of the number of centers that are conducting clinical research. By now, we roughly estimate that the country has between 600 and 700 active sites.
Q: How is APEIC promoting Mexico as a destination for clinical trials?
A: During early 2017, AMIIF began an initiative to fuel clinical research in Mexico alongside COFEPRIS, the CONBIOETICA, the Coordinating Commission of National Institutes of Health and High Specialty Hospitals (CCINSHAE), ProMéxico and the main academic institutions, pharma companies and CROs, with the goal of raising awareness of the potential that Mexico has regarding clinical research. This initiative brings together for the first time the industry, including CROs and pharmaceuticals, academia and the authorities. One of the first results was the publication of a booklet to promote Mexico at international conferences and meetings. SAT is also working on this initiative to streamline imports related to clinical research. The goal of this interdisciplinary and multi-institutional initiative is for Mexico to enter the Top 10 countries with the largest number of clinical trials within the next five years, taking advantage of Mexico’s several significant and natural advantages. Just to have a point of comparison, South Korea is among the Top 10 countries in number of trials but has only a third of Mexico’s population.
Q: How is APEIC working with local authorities to streamline clinical trials in Mexico?
A: Although we should recognize that COFEPRIS has improved greatly over the last four years, there is still room for a greater contribution. The commission is a leader in the region in several areas, including its approval times, but these can be shortened to further increase the country’s competitiveness. There are some ongoing initiatives that eventually can have a good impact, such as the merging of the three committees currently needed to approve clinical trials into a single entity. Authorities are aware of the existing hurdles and are working alongside us to solve these matters.