Assuring Optimal Site Quality ParamountWed, 09/09/2015 - 09:20
Q: How would you classify Mexico’s success in attracting clinical trials to date?
A: By comparing the number of trials implemented in Mexico to other countries in Latin America, we can perceive that we are in a competitive position. There is evidence that the quality of research in Latin America is on par with any other country in the world. Although there are some problems in the region, we have also clear strengths and we are trying to promote the industry among decisionmakers all over the world. To attract foreign companies, we are increasing our collaboration with academia and with research institutions, with a host of great researchers who have a mainly academic approach. I would say that their focus is on clinical training and academic research so they have little interest in clinical trials. At the same time, clinical investigators perceive the CROs as intermediates between themselves and international pharmaceuticals. So our current goal in Mexico is to improve our relationship with universities and research institutions in order to promote the importance of recognizing professionals in the field of clinical research.
Q: What is your opinion on the timelines involved in bringing a product to the market in Mexico?
A: Mexico has very well defined processes to approve clinical trials. We are working together with the government to address pertinent issues, and timeframes in Mexico are now shorter than in other Latin American countries. The approval process takes about six months from the beginning of the process to the final decision by the regulatory authorities. In general we are working within very competitive parameters and on average, the speed of obtaining approval is faster than that of other large countries. There are three steps that dictate the whole approval processes. Firstly, the company submits the subject drug to regulatory authorities. While this is a relatively efficient process, there are still some areas of opportunity to simplify our internal procedures. The second step is related with the approval from ethical committees as required by the regulatory agency. The third component in the clinical trials approval process relates to the agency review (COFEPRIS). They have an official timeline of three months, and although timeframes have improved, there are still delays and backlogs.
Q: Is COFEPRIS taking the right action in order to speed the process along?
A: We have seen significant cooperation and COFEPRIS has proposed new initiatives to improve timelines. They separated approvals from amendments, which used to run simultaneously and was problematic since there are usually several amendments per protocol. We are also exploring other alternatives, such as the possibility to run the ethical committee approval process parallel to the approval process by COFEPRIS. Right now, unlike in other countries, this process is sequential: ethical committees have to approve the proposal before it can be submitted to COFEPRIS. In 2013 a new and efficient initiative called Unidades Habilitadas para la Aprobación de Proyectos de Investigación (UHAP) was launched. Nine units were created at the most important national institutes of health in Mexico with the objective of accelerating the approval process. Working independently from ethical committees, they evaluate the documentation, and within 30 days submit it to COFEPRIS who will then require only 20 days to review it, reducing the approval time by about a month. COFEPRIS also has a new initiative to alleviate their backlog of clinical trial approvals before the end of the year called the Grupo de Alta Productividad (GAP). They contact every company that has projects with pending approvals, requesting additional information as needed in every case, and once provided, they agree on a meeting to review the submission.
Q: More clinical research centers are acquiring certifications – how important are these?
A: We all agree that training and certification will bring widespread benefits to the industry. However, while certifications are useful, by themselves they do not prove that a site is compliant with regulatory practices. Certification is different to effective performance. A global problem is the lack of a certification that can guarantee quality performance in research. A company needs internal certification to prove they are compliant with ICHs and GCPs and that they are trained in good clinical practices but there is no official accreditation for this. Like in many countries, in Mexico there is no mandatory certification to conduct pharmaceutical research. As CROs, we are most concerned with assuring the quality of the site.