Because the ultimate goal of pharmaceutical research is to improve and save lives, and aware of the importance of equity to avoid gaps in science that exclude more groups, Merck implements programs to ensure that participation is more equitable for the group that complies. the inclusion criteria requested by the trial in question.
Lourdes López-Bravo, Executive Director of Clinical Operations at MSD in Spain, sums up her philosophy: “We are committed to equity, equality and that patients can benefit from clinical trials with new treatments under investigation and contribute to biomedical progress. And we're also working internally to make research accessible to more patients regardless of where they live. Committed to achieving equitable diversity clinical trials and ensuring they are representative of patients who may benefit from these new treatments in the future." Today the company works so that a diverse population can participate in its clinical trials, and it carries them out in more than 50 countries.
According to the data from the latest Profarma report, in 2021, only in Spain MSD invested 109 million euros in R D i , 13% more than the previous year. MSD in Spain is positioned within the Company as the subsidiary with the greatest participation in clinical trials and active patients, after the United States. The number of clinical trials in Spanish territory in 2022 reached 169, 1.19% higher than the figure for 2021. In addition, MSD Spain participates in research studies in most of the company's therapeutic areas on a global scale.
According to Farmaindustria data, in 2020 Spain reached the record number of one thousand clinical trials authorized by the Spanish Medicines Agency (AEMPS), ranking as one of the countries in the world with the largest number of trials. “Spain brings together important characteristics that make us leaders in the field of clinical trials: the excellence of our health system and the high professional level of its researchers, the agility of our regulatory authorities, specifically the AEMPS, or the close collaboration between the various pharmaceutical companies and hospital foundations, thanks to the promotion of the Farmaindustria Best project”. The executive director of Clinical Operations of MSD in Spain explains this to us, who adds that "all of this places us as a country of trust, with a growing reputation in the international arena, attractive for investment in biomedical research, and in which it is possible to develop research, essays and projects”.
A reputation that –according to López-Bravo– continues to grow thanks to the work of our researchers. “Many are signatories of prestigious research studies in the main journals of medical-scientific impact.
The circuit of all new medicines, vaccines, treatments or devices is agreed upon by international legislation. No new drug can be accepted for use without first undergoing a clinical study, research that tests how the human body reacts to these new drugs. These are complex processes that require 6-7 years of work and are used to verify the safety and efficacy of new drugs, which is key to being able to submit them for approval by drug agencies. The purpose is twofold: on the one hand, to test new ways of diagnosing, preventing or treating diseases, and, on the other, to assess the safety and effectiveness of new treatments still under investigation.
In this sense, "the role of the AEMPS has been key to the positioning of Spain in this field". From his position at MSD Spain, López-Bravo explains that the agency has been a pioneer in the European Union in adopting the European directive that regulates clinical trials. “Thanks to this, we have been able to significantly shorten trial times and approval, which has allowed us to be more competitive at start-up and accelerate recruitment.
Public-private collaboration is essential when it comes to health research and innovation. “Clinical trials require the efforts of numerous agents, including the pharmaceutical industry, health professionals, the administration, the autonomous communities, patients, etc. The latter are increasingly involved, playing an active role and valuing clinical research as an opportunity to opt for new therapeutic alternatives”.
MSD's clinical studies in Spain cover all of the company's focus areas: oncology, vaccines, cardiovascular, endocrinology, neurology, antibiotics and virology. For example, in the field of oncology, the Company has the largest immuno-oncology clinical research program in the industry, with more than 2,000 trials across a wide variety of molecules, indications and treatment settings.
"The area of vaccines is another of our key areas," says Lourdes López-Bravo. “We produce vaccines for 11 of the 17 diseases in the immunization schedules recommended by the Centers for Disease Control and Prevention (CDC), we conduct cutting-edge research programs to discover and develop new vaccines for address important unmet medical needs, and we have extensive and strong experience finding vaccine candidates, such as the Ebola virus vaccine, approved in 2019.” The biomedical company is one of the few companies that continues to investigate to combat the threat of antimicrobial resistance (RAM), a growing danger already responsible for the death of 25,000 people in the EU and which calls for the development of new antibiotics.
Technological innovations are revolutionizing healthcare. In line with this revolution and placing the patient at the center of her work, MSD's research also imposes the premise of facilitating daily life.
