The advance of diseases, the appearance of new infectious agents or the resistance of some viruses or bacteria to current therapies, forces the world of science to look for new treatment alternatives.
In this context, it is very important Clinical studies. This is research that seeks to test the efficacy and safety of new drugs, vaccines, devices or other formulas that are developed in order to find better ways to prevent, diagnose or treat a disease.
Each clinical study has different stages and a very rigorous protocol that must be followed. In the case of Chile, it is the Public Health Institute (ISP) the body in charge of authorizing the performance of these trials in order to protect the rights and well-being of the participants and ensure the quality of the data obtained in the research. Approval by independent Scientific Ethics Committees is also required, which ensure that the studies comply with all international standards of good clinical research practice.
USS Center
The Universidad San Sebastián participates in five multi-centre clinical studies to test new vaccines. These are vaccines against SARS-CoV-2, Influenza and Pneumococcus, three respiratory microorganisms that cause a great burden of morbidity in the country.
“We aspire to be a national reference center for the development of clinical studies that have an impact on patient outcomes, in clinical practice and public health”, explains Pilar Espinoza, director of research, postgraduate and international outreach at the Faculty of Sciences of Sciences for Health Care.
The teacher comments that Currently, work is being done on the creation of a USS Clinical Studies Centerhand in hand with Faculty of Medicine and Science.
Studies
The first experience in this area was the participation of the USS in the multicenter study to evaluate the efficacy, safety and immunogenicity of the vaccine against the SARS-CoV-2 virus (CoronaVac), led in Chile by the Pontificia Universidad Católica and the laboratory Sinovac Biotech, where the University was invited to participate along with other institutions.
As Espinoza explained, this “It allowed us to realize that we have the know how necessary to become a reference center, at the same time that we began to be required by other institutions to do this work”.
The University is currently participating in four other Phase III Clinical Trials, that is, they seek to answer whether the new intervention under study is not inferior or superior to the conventional one, explains Dr. Carlos Pérez, Dean of the Faculty of Medicine and Science and researcher responsible for these studies together with Professor Espinoza.
One of them is the study of a new tetravalent vaccine against Influenza from Sinovac Biotech that aims to evaluate the immunogenicity and safety of the pharmaceutical product in comparison with another tetravalent vaccine, available on the market, to be used by people over three years of age and that is sponsored by the PUC and Sinovac Biotech (Chile).
Two other studies are to assess the safety, tolerability, and immunogenicity of a new pneumococcal vaccine, in different population groups.
Espinoza adds that they are in talks with Sinovac Biotech (Chile) to soon begin the study of a new vaccine against SARS-CoV-2, Ómicron variant.
“Our objective is to generate scientific knowledge that responds to the relevant health problems of the population, in order to socialize these results with the academic and scientific community at a local and international level. We are trained to provide expert guidance, methodological, logistical and structural support for the development of clinical studies”, concludes Pilar Espinoza.
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