COVID-19
São Paulo, January 21, 2021.
Abracro, the Brazilian Association of Organizations Representing Clinical Research, calls for the inclusion of Clinical Research Monitors in the priority group for vaccination against Covid-19.
Clinical trials are the final stage in the research and development process for vaccines, medicines and other medical technologies. Carrying out new clinical studies and continuing with ongoing ones in all therapeutic areas is essential if the efficacy and safety of innovations are to be validated and reach the population. The delay or cancellation of clinical studies increases the burden on health systems, whether private or public. Clinical research is especially important during the pandemic, where there is a focus and urgency in the search for vaccines and treatments against Covid-19, but which cannot fail to meet the needs of participants in studies in other medical specialties, such as oncology, cardiology and others.
Within the complex chain of professionals involved in carrying out clinical studies, Clinical Research Monitors are the front-line professionals.
Clinical Research Monitors are professionals appointed by study sponsors and are responsible for supporting the implementation of clinical studies in healthcare institutions. One of their many responsibilities is the process of verifying and validating the data collected during these studies. The main activities of this professional take place in face-to-face visits to research centers, which in turn are healthcare facilities (hospitals, clinics, among others). Even with the use of advanced technological tools, face-to-face visits are still mandatory. At research centers, monitors spend hours in a high-risk environment, especially when conducting studies related to treatments and vaccines for Covid-19. Within the process of monitoring a clinical study, there is direct contact between health professionals from the institutions participating in the studies and monitors, movement through environments at high risk of Covid-19, including public transport, especially by air, and handling of physical documents, which have already passed through the hands of the study site staff or even the hands of the study participants.
Thus, Abracro believes that Clinical Research Monitors should be part of the priority group that considers health professionals, nationwide, in immunization programs against Covid-19.