Regulation Key to Unlocking Clinical Trial Potential

Q: How has the acquisition by CTI Clinical Trial and Consulting Services changed Eurotrials’ operations in Mexico?
A: The acquisition gave Eurotrials a broader footprint, opening the doors to the Americas, Asia, Europe and Oceania. It also diversifies our service portfolio to include development and strategy, clinical services, research, life-cycle support and real-world evidence and late-phase research. CTI has 20 years of experience as a multinational company providing services to 18 of the 20 largest pharmaceutical companies in the world. We are now following all of CTI’s standards and procedures.
In Mexico, we are focusing on two areas. The first is epidemiological and real-world evidence studies, both of which are in high demand by the pharmaceutical industry. The second is rare diseases, a CTI specialization. Our studies in both areas are feasible in Mexico thanks to the country’s large population, which proves an advantage when researching rare diseases as the number of patients is usually quite small in other regions. Eurotrials has worked with treatments for Fabry disease and lysosomal diseases in Mexico. In 2019, we plan to develop several projects addressing diseases common to the country, such as type 2 diabetes.
Q: How would you describe Mexico’s local capabilities for clinical trials and what is Eurotrials looking for in the research centers it partners with?
A: It is necessary to change regulations concerning approval times both for clinical trials and for registration of new medications. Mexico has efficient approval times on paper but regulations are not consistently applied and delays are common. Long and sometimes unpredictable processes leave Mexico as a second choice for pharmaceutical companies that prefer Eastern European countries, where times are shorter and trials are less expensive. These countries have the disadvantage of having a much smaller population than Mexico, making recruitment harder.
Having said that, Mexico has a large number of researchers who have worked for many years in the sector. Many started in public institutions and then opened their own research centers, which are now performing their own clinical trials. These centers are fully staffed with specialized doctors and experts in clinical trials. We are looking for research centers with fully dedicated professionals who have that kind of expertise.
Q: How can CROs help to increase access to healthcare services in Mexico?
A: Clinical trials provide a way for patients to access innovative medicines before they are available in the market. This is especially important in Mexico because the registration process for innovative treatments is too long, so patients do not have timely access to the medications they need. It is necessary for the government to develop strategies to support access to clinical trials and to see them through. Some measures have already been implemented, such as the development of Habilitated Units for Preapproval Support (UHAP), which review all documentation and preapprove research protocols before they are analyzed by COFEPRIS.
It is also necessary to speed up the implementation of clinical trials at public institutions like IMSS and ISSSTE, as this would give a broader number of patients access to medications and it would make these more affordable. Long approval times and delays in the process add up and increase the final cost of the medication for the patient. Shorter trial periods would allow Mexico to compete globally with major players and to reduce the final cost of medications. IMSS, AMIIF, CANIFARMA and ACROM are searching for ways to speed up approvals.  
Clinical trials also train physicians and hospital researchers in methodologies and standards that have proven to be useful in establishing processes and improving organization in institutions and researchers’ own initiatives. This is important for Mexico to grow into the new trends of collaborative research where public institutions and other industry participants design common projects and share knowledge to solve society problems that span from unmet medical needs to rare diseases or pathologies.