Jenny Paredes
View from the Top

An Association to Support CRO Growth

Wed, 09/09/2015 - 09:15

Q: You were recently named president of ACROM. What are your plans and goals for the association?

A: ACROM was established five years ago with three primary aims: to become known as the main Mexican body for clinical research, to upskill staff on project management and study coordination, and to organize conferences with national and international organizations. These three main goals have been addressed, so we are evolving towardsdirect influence on Mexican legislators by working in conjunction with other associations such as COFEPRIS and the National Bioethics Commission, responsible for the legislation governing all the ethics committees in the country. We also work with IMSS in its push to increase its number of clinical trials nationwide. The CROs under ACROM currently conduct 90% of all research in Mexico.

Q: Does ACROM place importance on the creation of relationships with academia and research organizations?

A: We are collaborating with some universities like UNAM, ITESM, UAM, and La Salle to establish research training models. We also want to organize a job fair to ensure that students are aware of the wide range of possibilities that clinical research can offer as a career. The expansion of clinical research should create many new jobs but, if students are unaware of its existence, we will have a lack of qualified professionals. After that, the next step is to raise awareness about the importance of commercializing research. There is still a lot of work to be done here as many investigators do not understand the need to commercialize research. CONACYT has a comprehensive scholarship program with CANIFARMA but these are too focused on basic research and not on clinical research. We need to work together to increase the number of clinical studies being carried out. In 2014, we signed a collaboration agreement with AMIIF because they expect to make a huge investment on clinical trials by 2020.

Q: COFEPRIS will publish a revision of NOM 12 this year. How will this affect ACROM and its members?

A: The industry has witnessed considerable change in the last three years as COFEPRIS has become far more open to collaborating with associations in the review and proposal of new policies. The old regulations were often confusing, which delayed our work and the approval process. Now, we meet with the Ministry of Health on a monthly basis to discuss the new regulations and representatives of every association review all the information. We are now able to have an open and frank discussion with regulatory authorities. However, we do not expect many changes to the current regulation, since these alterations would only add to the elements companies must comply with. Instead, any modifications should help authorities to catch up with their backlog and become more efficient by standardizing processes across the country.

Q: You are also creating an association of CROs in Latin America. To what extent will you ally yourself with existing CRO associations in other countries?

A: In 2014, we began an initiative called ACROM LATAM, aimed at uniting all CRO associations in Latin America. The goal is to standardize processes and to harmonize communication across all the countries involved. We are still working toward this goal since, at this point, we are still establishing ACROM LATAM’s regulatory framework. There are many different working cultures involved, making our standardization efforts all the more complex. At the same time, ACROM is also trying to gain recognition by TransCelerate, the main association of CROs in the US in order to increase its presence and influence.

Q: To what extent do you expect the clinical trial industry to grow in Mexico within the next three to five years?

A: This area grew by 5% in the last five years but has the potential for considerable future growth. Mexico has a lot of strengths but the main one is the size of its patient population, which will only keep growing. The public health sector already no longer has the capacity to provide services to this vast population, so by carrying out clinical research in Mexico we would be able to offer patients more options for care. Patients in Mexico still have a good patientphysician relationship, meaning that they trust their doctor’s prescriptions and suggestions. This is highly dissimilar to other countries where patients often request a second or a third opinion. Another advantage is that most of the Mexican population lacks access to health insurance, which makes clinical research potentially beneficial for them as an alternative to access innovative treatments.