O processo de trabalho dos coordenadores de ensaios clínicos no Brasil

Abstract

The study refers to the work process of clinical trial coordinators in Brazil. Its objective was to understand the work process of clinical trial coordinators at Clinical Research Centers in Brazil. This is a study with an exploratory descriptive method, with a qualitative approach, developed in two stages. The selection and recruitment of study participants took place from a WhatsApp group called: Pesquisa Clínica Brasil, after approval by the Human Research Ethics Committee of the Federal University of Juiz de Fora (UFJF). The first stage involved filling out the semi-structured questionnaire on Google Forms and was carried out from August 2022 to July 2024, consisting of 44 participants. The second stage consisted of 08 participants who were selected by drawing lots among the participants in the first stage and was characterized by the semistructured interview on Google Meet that took place from April 2024 to July 2024. The data obtained in the first stage were extracted into the Microsoft Excel 2007 program and the interviews conducted in the second stage were recorded through Google Meet, saved on the researcher's computer and, then, the data were transcribed in the Microsoft Word 2016 program, and to ensure anonymity the participants received a coding. To support the preparation of the report, the study followed the guide for qualitative studies Consolidated Criteria for Reporting Qualitative Research (COREQ). The content was analyzed and categorized according to the content analysis according to Bardin, with three thematic categories being established: The Figure of the Clinical Trial Coordinator; Management of the Research Center and Coordination of the Clinical Research Protocol. In the results, the three areas of training that stood out most in the survey were nursing and pharmacy, with 27.27% in each area, followed by biomedicine, with 8.18% of participants. Nurses have occupied a space in clinical research in a variety of roles and in a variety of settings, and a fundamental role is that of clinical trial coordinator. The clinical trial coordinator plays a fundamental role in leading clinical trials, a key figure capable of managing the workflow, a professional reference for the coordination of the various activities and professional figures involved. It is necessary to understand and systematize the skills profile of the work process of this professional who stands out in the advancement of the advancement of health sciences, through clinical trials.