With the entry into force, this Monday, January 31, of the Clinical Trials Information System (CTIS), clinical trials in the European Union are going to undergo important changes for the benefit of patients, as they are harmonized the processes of presentation, evaluation and supervision of the same in order to expedite them and, consequently, that the new medicines reach the market before.
With the CTIS, clinical trial sponsors can request authorization for a clinical trial, simultaneously, in all EU countries with a single application that covers submissions to competent national authorities, ethics committees and public registration of the clinical trial .
The European Medicines Agency (EMA) has stipulated that Member States work on the CTIS from its launch, as soon as clinical trial applications are submitted to them through the new system. The promoters will be able to use the new system or the previous one for a year, but from January 31, 2023 they will have to use the centralized platform for the new trials they want to launch. Finally, the EMA has set a transition period of three years, and all the information on these studies must be fully transferred by 2025.
Advantages for Spain
According to Farmaindustria, the employers’ association of innovative laboratories, Spain starts out in an advantageous position in this area, since it was the first country in the EU to adopt the European Regulation on Clinical Trials -in which the CTIS is framed-. It did so with Royal Decree 1090/2015 and this meant the simplification and harmonization at the national level of the procedures before any other Member State; the reduction of times in the start-up of the studies; an increase in trials in early phases, which are those that require a higher level of complexity, and a greater commitment to research in rare diseases and in the pediatric population.
Our country has also been one of the first to carry out the necessary training for the use of this new platform. Coordinated by the Spanish Agency for Medicines and Health Products (Aemps), and in collaboration with Farmaindustria, preparation meetings have been held since the end of last year with technicians from the agency for pharmaceutical companies and members of the ethics committees in the investigation of medicines (CEIm). “In fact, many of those responsible for the new process to develop clinical trials in our laboratories in Europe are Spanish because they already have experience in simplifying processes and coordinating between agents,” says Amelia Martín Uranga, associate director of Clinical Research and Translational of Farmaindustria.
Spain, reference in clinical trials
According to the information provided by Farmaindustria, Spain has become an international benchmark in clinical trials, which is a very good competitive advantage for our country to continue growing and attract even more investment.
And it is that the trials not only offer new hope for patients, but also have very positive economic consequences for the health system. They attract financing from the promoting pharmaceutical companies to the participating hospitals, both public and private, and represent the first source of private income for the centers. In addition, they add reputation, experience and knowledge to the health professionals who perform them, placing them at the scientific forefront, which they can apply in their care work.
“The joint work between all the actors, public and private, has made it possible to update and optimize the management of clinical trials, and this collaboration has had its reflection during the pandemic, since we have become the first country in Europe and the fourth in the world. world by number of clinical trials for Covid-19”, recalls Martín Uranga. “Today there are some 3,500 drug clinical trials underway in Spain, in which more than 130,000 patients participate,” she adds.
Another proof of Spain’s capacity in clinical research is that, in some of the international trials with Spanish participation, according to data from the companies themselves, our country has been the first to launch the research project, in record time, and even in some cases the first patient to enter the clinical trial was Spanish.
Currently, researchers and health centers in Spain already participate in one out of every three clinical trials carried out in Europe, and for some of these companies, Spain is already the preferred destination for their investments in clinical research after the United States. Another fact: in 2020, 1,027 authorized clinical trials were reached in Spain, a historical record, according to Aemps data, and that despite the extraordinary difficulties caused by the pandemic.
In the last year, Spain has also managed to significantly reduce the times of some processes related to clinical research thanks to digitization. This is the case of the signing of contracts, where it has gone from the 108 days registered in 2019 to 79 days in the first half of 2020.
The BEST Project, a lever for R&D in our country
A large part of these successes are the result of the BEST Project, launched in 2006 by Farmaindustria and which includes 60 pharmaceutical companies that promote research in Spain, 13 autonomous communities, 52 public and private hospitals and six independent clinical research groups. BEST’s purpose is to monitor clinical trial processes and take steps to improve their efficiency and competitiveness. It currently contains information on almost 4,000 clinical trials and facilitates the monitoring of the most important indicators in clinical research.
Our country, therefore, has the potential to become one of the world’s leading countries in drug research. For this, it is necessary to create a solid biomedical research ecosystem, which also promotes basic and preclinical research with a research network in which public and private initiatives interact and collaborate continuously and efficiently.
“Now, given the increasingly demanding requirements of cutting-edge clinical research and the challenges to maintain and improve Spain’s competitiveness, we must adopt a flexible, innovative, anticipatory stance, always in a collaborative environment”, concludes the spokesperson for Pharmaindustry.