Miriam Serrano
President
Association of Professional Specialists in Clinical Research (APEIC)
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The Right Clinical Research Professionals

Wed, 09/09/2015 - 09:17

Q: What is APEIC’s mission? Can you tell us about some of its key activities?

A: Our mission is to convene all the area’s clinical research professionals so as to establish a tight network. Our main goal is to strengthen our human capital and maximize Mexico’s competitiveness in the field of clinical research. In the short term, APEIC focuses on building strategic alliances with various stakeholders in clinical research, which include the relevant government authorities, research institutes, patients, and pharmaceutical industry players. We also seek to work with independent review boards and ethics committees (IRBs and IECs), contract research organizations (CROs), and other vendors.

Q: What needs to be improved to attract further multinational studies?

A: The research industry in Mexico is facing a number of noteworthy challenges at the moment. The industry is sensitive to changes in clinical trial timelines and the startup time in clinical trials is one of the most relevant indicators of global competitiveness. The number of clinical trials conducted in Mexico over the last five years has fluctuated, and a direct correlation can be observed between regulatory timelines and these variations. Research industry growth is stalling overall, and therefore reducing startup times is key if we are to capitalize on Mexico’s full potential, which could amount to three times the current investment levels. We need to be sure that all key stakeholders across the board are aware of their responsibilities where regulatory requirements are concerned.

Q: To what extent does clinical research appear to be an attractive and profitable field for young professionals?

A: The ideal clinical research professional is an individual whose experience, training, and education provide the skills to yield high quality data. Research subjects’ rights, safety, and well-being are protected by local and international regulations, as well as scientific and ethical standards. Therefore, an awareness of all of these regulations is crucial. Another important factor is the researcher’s ability to meet trial commitments – timelines, recruitment, quality assurance as well as their own predictability. Research professionals receive a direct reward from continuous, specialized education, a steady job, and from highly competitive salaries. Mexico has great potential to grow in clinical research, so this is a fertile field for young professionals who are integral in accelerating this growth.

Q: Plenty of research projects are being overlooked. How are you closing the gap to increase productivity and competitiveness in research?

A: First of all, APEIC works hard to ensure that both sectors realize that clinical research speaks only one language, as defined by scientific and ethical principles and regulations. By sticking to this script, it will eventually become clear that everybody is pursuing the same goals. The most efficient way to achieve these goals is by working together and capitalizing on every possible synergy. On one hand, the pharmaceutical industry needs scientific breakthroughs to drive innovation. On the other hand, the academy depends on technical and economic support to continue research. As a result, the academy and industry should and must be a highly productive partnership. This partnership is crucial to the local pharmaceutical industry and academy, since it will enable the Mexican industry to shift from replicating products such as generics and biosimilars to developing innovative solutions that address those local health needs that are not currently being met. Furthermore, the academy will benefit from transforming its research programs into tangible benefits for society, which is the common goal of both sectors.

Q: What other major events have you planned for this year?Can you tell us about your main priorities going forward?

A: Our first priority is to carry out a census on the current state of medical knowledge among clinical professionals nationwide. Based on this data we can identify training needs and thereby plan our annual academic program, which will then be integrated into our national conference. We also plan to launch the National Program of Certification of Clinical Research Professionals (CRP), with a view to demonstrating that CRP in Mexico have the skills, knowledge and expertise required to compete at a global level.