title: Clinical trials profile: professionals and sites.
abstract: Clinical trial is considered a breakthrough method in medicine and essential to the development of new drugs. Clinical trials that comply with international and national regulations require an appropriate infrastructure and team qualification. The goal of this study was to evaluate clinical trial groups in Brazil: professional qualification, site structure regulatory knowledge and Good Clinical Practice (GCP) adherence. This is a transversal study with investigators (PI) and sub investigator (SI). PI and SI data were initially identified from Curriculum Lattes from National Advice of Scientific and Technological Development. The study participants were submitted to a questionnaire, which was composed of qualitative and quantitative questions. A hundred PI and SI were interviewed. The most representative Brazilian regions were Southeast (68%) and South (18%). The main institutions involved were HCFMUSP complex and UNIFESP among others institutions. Academic graduation is observed in 86% of them and the higher degree is Doctorate (62%). 91% had GCP knowledge although only 74% had formal training. About the team, all of them are multidisciplinary with majority of nurses and pharmaceuticals. 88% had GCP knowledge although only 77% had formal training. 36%, 60% and 44% of clinical trials were in phase II, III and IV. In conclusion, researchers have appropriate skills and knowledge to perform clinical studies however there is still a need for training. The centers where the researchers work, have trained staff and adequate infrastructure for conducting clinical trials phase II, III and IV.
authors.affiliation: Department of Gastroenterology, University of São Paulo School of Medicine, Brazil.
authors.forename: Helena S
authors.initials: HS
authors.lastname: Paschoale
authors.forename: Fernanda R
authors.initials: FR
authors.lastname: Barbosa
authors.forename: Marcelo E
authors.initials: ME
authors.lastname: Nita
authors.forename: Flair J
authors.initials: FJ
authors.lastname: Carrilho
authors.forename: Suzane Kioko
authors.initials: SK
authors.lastname: Ono-Nita
mesh_terms: D035843:Biomedical Research / Q000458:organization & administration / Q000592:standards*; D001938:Brazil; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D004345:Drug Industry / Q000592:standards; D004522:Educational Status; D014943:Global Health; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007391:International Cooperation; D036301:Qualitative Research; D012108:Research Personnel / Q000592:standards* / Q000600:supply & distribution; D011795:Surveys and Questionnaires; D000078329:Workforce