Cecilia Moreno
Director of Clinical Management
PPD
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View from the Top

How to Turn Mexico Into a Clinical Trials Hub

Wed, 09/05/2018 - 14:09

Q: How is the PPD study profile changing according to global scientific and health trends?

A: Mexico is a very important contributor to clinical trials in Latin America and provides a significant number of patients for clinical studies. Enrolment and quality are relevant in the Latin-American region, particularly as innovation increasingly focuses on areas like oncology, immunology and rare diseases, with an expansion of activity in biologics and genetic diseases. Globally, studies are evolving to incorporate new types of drugs, such as genomic medicine and biosimilars. For PPD in Mexico, we are prepared at all levels and already have entered this new era. We implement multi-centric studies, mainly Phase II and III trials.

As molecules become more complex, studies also have become more complex and require a more circumscribed patient profile. In the case of genomic medicine, these tests limit the number of potential patients. However, given its large population and extensive experience in the clinical research field, Mexico has great potential for finding these study subjects. Also, there is a growing number of personalized medicine, HIV and hepatitis trials being initiated in our country.

Q: How does collaboration with public healthcare institutions support the development of clinical trials in Mexico?

A: Public institutions have a much larger concentration of patients compared to the private sector. Large numbers greatly facilitate finding the required patients for many types of trials. But, unlike other countries, public institutions still need to build the necessary capabilities for clinical trials in terms of infrastructure, personnel, time and qualified researchers. Clinical research differs from regular medicine in that it requires much more documentation and follows many more regulations. In many cases, hospitals do not have the number of experienced, qualified researchers or the infrastructure and personnel necessary to perform these trials and provide the necessary administrative support. We must ensure ethical research, considering that our main priority is patient safety followed by the quality of data generated to support clinical studies results. Our industry has a successful history conducting studies in the public sector. We rely on highly professional personnel and institutions who understand the necessary requirements to support clinical research. The number of patients who can be treated is now more significant, as well as the benefit of receiving new treatments and having access to specialized exams and diagnostic tests. Several studies are going to be introduced for oncology, immunology, rare diseases and orphan conditions, so collaboration is key to continue to expanding clinical research in Mexico.

Q: How does PPD ensure the acquisition of enough patients for its clinical trials?

A: We are working with networks that already have research centers experienced in patient recruitment and with qualified personnel, equipment and facilities. The time periods to subscribe patients and begin clinical trials are of the utmost importance. Mexico has reduced its waiting times and different players in the country are working to further reduce them to enhance efficiency. Specialized groups, such as experts in site selection at the startup phase, strive for prompt activation and rapid enrolment in a joint effort with sites. A regional approach to the ideal country mix is the most appropriate method to ensure enrolment with the highest patient safety and quality standards.

Q: What measures should be taken to strengthen Mexico’s position regarding clinical trials?

A: Performing clinical research in public institutions would be a significant first step toward Mexico consolidating as a clinical trials hub. The second step would be to attract more studies to Mexico, but to do so, it is necessary to keep on reducing startup timelines and increasing predictability. While Mexico has proven itself to be a quality location for clinical research, the country still needs to be even more competitive to attract more studies.