PROFILE OF PEDIATRIC CLINICAL RESEARCH IN BRAZIL IN THE PAST THREE YEARS (2018-2021)

Abstract

Introduction: according to data from the Brazilian Institute of Geography and Statistics (IBGE), the pediatric population is considered to be individuals aged up to 17 years of age, and the Brazilian pediatric population is estimated to be 61.5 million, which corresponds to 29% of the country's total population, which was estimated in the year 2020 to be about 210 million people and according to the Medical Demography in Brazil published in 2020, 10.1% of specialist physicians in Brazil are pediatricians. When profiling pediatric patients for clinical research, we found a shortage of studies that address this population, thus preventing the use of safe and effective drugs in pediatrics with specific formulations based on clinical and pharmacoepidemiological studies that are suitable for this target audience. Therefore, in their different age groups, children and adolescents are exposed to drugs whose clinical benefit is only known in adults. Objective: based on the challenges for the development of pediatric clinical studies and the great importance and need for clinical research for this target audience, this study sought to identify the profile of pediatric clinical research in Brazil in the last three years (2018-2021) and discuss your challenges and opportunities. Method: the present research consisted of an observational, cross-sectional and descriptive study and considered clinical trials and expanded access exclusively in the pediatric population. A survey was carried out in the Clinical Trials.gov® database of pediatric clinical trials in Brazil, including expanded access programs, registered from January 6, 2018 to June 1, 2021. For this survey, the Clinical Trials database. Gov® was accessed on July 30, 2021 at 7:22 pm. The following keywords were used as a search filter: “Brazil, Child (birth–17) and Study Start (MM/DD/YYYY): from 01/06/2018 to 06/01/2021”. Data extracted from the Clinical Trials database. gov ® were recorded in a spreadsheet using the Microsoft Excel® 2010 program. After checking the consistency of the data, a descriptive analysis was performed. Results: The research gathered 264 studies related to clinical trials in pediatrics in Brazil, but only 107 of the studies met the proposed design criteria. According to the results between the years 2018 and 2021, there was a drop of more than 34% in the total number of studies for pediatric patients. In this same period, it is possible to affirm that more than 97% of the studies do not have gender differentiation and the concentration of the study center located in the Southeast region of Brazil, with the city of São Paulo being responsible for housing 28% of them. Also, according to data obtained, 41% of the studies are still in the recruitment phase and only 24% have been completed. The area of greatest research interest is in Dentistry, and research on Rare Diseases did not reach even 1% of the topics studied. However, during the period between 2018 and 2021 there was a shift in research sponsorship sectors, moving from public to private. Conclusion: as a result of the significant drop in clinical studies in pediatrics in Brazil in recent years, as shown in the results, prescribers and patients will be left with no alternatives for accurate and safe therapeutic treatments for the Brazilian pediatric population. Considering that 43% of pediatric clinical studies in the “recruitment” phase in Brazil are concentrated in the year 2019, the lack of new clinical research in pediatrics in recent years may suggest an increase in the “off label” use of medicines in pediatrics due to the absence of research with sufficient scientific evidence in this therapeutic area. Almost all pediatric clinical studies in Brazil were carried out with the participation of all genders, which demonstrates that specific diseases of each gender are not part of the scope of these pediatric studies, as well as rare diseases that were not in the researched topics. Regarding the geographic distribution of clinical studies in pediatrics in Brazil, it was observed that more than 60.7% of these clinical studies were conducted in the Southeast region, mainly in São Paulo, followed by the South region, with 27% of the concentration of these studies. These results reaffirm IBGE data on regional inequality that is reflected in the concentration of investments, research centers and researchers in these regions of the country.

Key words: Clinical research; Clinical Study; Pediatrics; Brazil.