Yomana Khoury
Manager Clinical Operations, Strategic Resources
inVentiv Health
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View from the Top

Mexico Offers Unparalleled Advantages for Clinical Research

Wed, 09/07/2016 - 12:20

Q: As a global CRO, how did inVentiv Health initially become attracted to Mexico?

A: Mexico has a broad patient population, qualified professionals, the right infrastructure and supportive regulations for clinical research. It continues to offer unparalleled benefits to any clinical development program including consistent regulatory laws, quality assurance through strong adherence to ICH-GCP norms and adequate technology. Mexico has reliable, well-trained investigators and a strong patient-doctor relationship, resulting in good compliance and high retention rates. The population is mostly concentrated in metropolitan areas and there are many public and private hospitals with consistent standards of care, which guarantees patients will easily attend their treatments.

Q: What needs to be done to take advantage of such features and bring more investment in clinical trials to Mexico?

A: Culture plays an important role in the way clinical research is perceived among patients. In the US, people are familiar with clinical trials and are willing to participate because they know their safety is never compromised. In Mexico more education of the public is needed about what a clinical study is, how it is regulated and the benefits. Many patients miss valuable opportunities to improve their health due to ignorance.

Q: How would you evaluate Mexico’s infrastructure capabilities for clinical trials?

A: Some public institutions are already working with big pharmaceutical companies and CROs and there are private centers with solid infrastructure for trials. To comply with Good Clinical Practice, research sites have to ensure the right facilities. Some institutions are not aware of issues such as a lack of staff training, expiration of emergency car medicines or lack of a civil protection plan. We let them know what we are looking for and work with them to improve their practice, procedures and operations. This is certainly more common in less experienced sites so they need to take courses and renew their certifications. Physicians and professionals in Mexico should also know the demand for services at clinical research sites is increasing, which can provide patients with better services and treatments.

Q: Some physicians think that clinical studies sponsored by the pharmaceutical industry are biased. What role do CROs play in making sure clinical trials are ethical?

A: Clinical research is not taught at medical schools but it is an actual profession. Therefore, some physicians who are not involved in clinical studies tend to ignore their scientific background and the basis of their execution. To conduct a clinical trial, it is mandatory to have ethics committee approval. CROs do not profit from the sales of drugs they help develop and our role is to maintain a neutral position during the trial. We have no interest in proving a medicine to be safe and effective but we are interested in conducting studies according to protocol and protecting patients’ safety.

Q: How can clinical research professionals and services in Mexico help the region improve its services?

A: Some countries in Latin America such as Argentina and Brazil have more experience in clinical research than Mexico. However, the latter has significantly grown in recent years and could replicate its success in other more immature countries. Guatemala has an attractive population and good private clinical sites but not enough trained professionals and certifications. When our workforce visits those places it performs its ordinary activities and helps them to improve. The same happens with our Colombian CRAs visiting Panama or other countries that train investigators and make sure the sites are compliant.

Q: What makes inVentiv Health a leader in clinical research?

A: We have supported more than 507 clinical programs in over 60 countries and over 45,000 patients in the last five years. Also, 89 percent of cardiovascular drugs approved by the FDA have been developed or commercialized by inVentiv. Seventy-eight percent of oncology drugs approved by the FDA have received assistance from inVentiv.