Karen Hahn, Director of Clinical Trial Management for ICON, speaks to Mexico Health Review on the advantages Mexico can bring to clinical research.
Q: What has shaped ICON’s evolution over the past year?
A: It has been a successful year for the company. We received recognition for the second time as the Best CRO at the Vaccine Industry Excellence Awards. Last year, we invested a lot in recruiting the best professionals and in having a bigger footprint for our private and public customers through our Vaccine Center of Excellence. Through this center, we lead research on vaccines for infectious diseases and global pandemics. We also received the Outstanding Partner Award from Amgen for a Functional Service Provider partnership we established a year ago for global project management.
Q: What is Mexico’s role in ICON’s global operations?
A: In Mexico, which is ICON’s biggest office in Latin America, followed by Brazil and Argentina, we employ 211 people and have high growth expectations. However, while Mexico and Latin America have a lot to offer, they lack exposure. The region represents just 6 percent of the global clinical research market, as attention is usually given to the US, Europe and Asia, but we are investing in strategies and working with associations such as ACROM, AMIIF and the Association of Clinical Research Professionals (APEIC) to make us more visible to the rest of the world. Fortunately, the new administration in COFEPRIS is maintaining continuity, bringing in new and good ideas and they are studying models from other countries’ regulatory organisms to see what could be useful for Mexico.
Q: What is Mexico’s value proposition as a potential clinical research hub for international companies?
A: The IMSS now allows clinical studies, which will provide great opportunities for the sector. The institution has a huge patient population 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.
Q: What techniques can be applied to increase patient recruitment and take advantage of the possibilities offered by the Mexican population?
A: We have a close relationship with patient-recruitment sites and provide quality training to professionals 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. There are many recruitment opportunities across the country, so we are expanding to reach a population we could work with and which is not receiving treatment.
Q: Many people do not know the benefits of receiving treatment through a clinical study. How are you taking this message to more patients?
A: We are designing a campaign with ACROM to explain the benefits of clinical research to patients. A few years ago, we did this for doctors who were not aware of the benefits of working in clinical research. ACROM also approaches many patient associations to inform them about the research we want to conduct. The effort to recruit patients is shared among all players in the sector.
Q: Where is technology development oriented at ICON?
A: ICON is committed to developing technology for monitoring based on risk. Our goal is to reach real-time analysis of what is going on in each site, so we do not have to wait till the end of the study to discover there were problems in measurements. Thanks to real-time analysis, we can assess trends and determine which resources each site needs.
Q: Which are the main therapeutic areas in Mexico that are driving the efforts of CROs?
A: There is a global focus on research in oncology and cardio-metabolic areas. However, we are investing to gain terrain in late-phase studies through ICON’s new Commercialization and Outcome hub in Mexico.