World Class Local Research FacilitiesWed, 09/09/2015 - 09:47
Q: What does your considerable experience in the regional clincial trials industry tell you about Mexico?
A: In 2000, I was relocated to Mexico and at that stage it was clear that Mexico was participating in very a small number of clinical trials. Most clinical trials were performed in Europe, Canada and the US, mostly because the pharmaceutical R&D areas were concentrated in those countries. Pharmaceutical companies slowly began to explore the option of Latin America playing a part in clinical trials. There are three key countries that interest pharmaceutical companies: Brazil, Argentina, and Mexico. Pharmaceuticals are generally more interested in these countries for clinical trials due to their established regulatory framework and experienced medical professionals. Mexico itself is a significant country due to the evolution of regulatory framework and the better understanding of clinical research practices among investigators and ethics committees. Additionally, the presence of the significant transnational CRO industry means that Mexico is now the second most significant country for participation in clinical research in the Latin American region.
Q: What is the history of Accelerium in performing clinical trials?
A: Accelerium was created in 2011 for the execution and administration of clinical trials in Mexico. We are pioneers in the industry, working alongside the biotechnology and pharmaceutical industries in collaboration with regulatory agencies in order to increase our international exposure. Now we offer several services to the local and international pharmaceutical industries including reviewing project feasibility, recruiting investigators and patients, and ensuring that studies follow national and international regulations. We have all the necessary resources to perform clinical trials including a management teams, clinical teams, investigators, laboratories, quality assurance, and a pharmacy. We also have experienced clinical teams with qualified specialists, nurses, technicians, and ethics and research committees. Our facilities and equipment are fully functional with 36 beds and specialized areas for interchangeable drug and biotechnology studies.
Q: What type of studies does Accelerium perform?
A: Our current 6.1km facility was created for the execution of a range of clinical trials including dental studies, bioequivalence and biotechnology studies from phase I to phase IV for the testing of drugs, biologics and medical devices. We are among the very few research sites that have the required international infrastructure to perform Phase I clinical trials in Mexico. We performed our first phase I trial just last year so this is still a very small operation. Of our current studies, 80% are clinical phases and 20% bioequivalence studies, since 95% of our studies are commissioned by international companies from the US or Europe.
Q: What are some of the main challenges facing the CRO sector in Mexico?
A: The biggest challenge for CROs is selecting appropriate research sites and meeting the deadlines for recruiting the number of volunteer subjects for each study contracted. Our international indicators illustrate that the clinical research industry is 50-60% behind schedule due to incomplete patient recruitment within the allocated time. A research site usually requires from three to 20 patients for a clinical trial depending on the drugs being studied and the study selection criteria. Selection criteria are also strict, and when selecting one patient for a particular trial more than two thirds of the evaluated patients are rejected due to incongruity with the study criteria. If a site fails to complete the patient recruitment within the allotted time it can be difficult for the CRO to promote future studies with the same client. Perhaps it is necessary to work on oversights related to training and site infrastructure in order to create better standards among the research sites.
Q: How do you identify the right patients?
A: Our first step is to analyze the patient population and the local incidence of the disease needed for any particular clinical trial. Subsequently, we approach physicians or investigators for potential patients that qualify according to the study criteria. The second strategy is to publish an advertisement in the local newspaper directed towards a particular disease or study. Patients associations proved to be an effective method of recruitment since we were able to find many groups of patients that have the same disease and are seeking alternative treatment.