Descrição e avaliação dos fatores associados ao término precoce de ensaios clínicos registrados no site ClinicalTrials.gov

• Autor(a) principal: Carrion, Maria Julia Machline [UNIFESP]
• Data de Publicação: 2016
• Tipo de documento: Tese
• Idioma: por
• Título da fonte: Repositório Institucional da UNIFESP
• Texto Completo: https://sucupira.capes.gov.br/sucupira/public/consultas/coleta/trabalhoConclusao/viewTrabalhoConclusao.jsf?popup=true&id_trabalho=3775722; https://repositorio.unifesp.br/handle/11600/46499
• topic: clinical trial; search; driving; organization; ensaio clínico; pesquisa; condução; organização

Background: Early termination of clinical trials represents a major concern for investigators, healthcare providers, patients and funding agencies. In the present study we aimed to determine the prevalence and predictors of early termination of interventional trials registered in a large trial registry database. Results: We identified 119,713 interventional trials registered in ClinicalTrials.gov up to june 2013 where 59,822 (49.9%) were completed and 6,524 (5.4%) were early terminated. Operational reasons represent the major motive why studies are terminated (58.1%), poor recruitment being the most important operational barrier (33%). Regarding predictors for early termination, when compared with studies funded by NIH, studies funded by other sources (such as academic institutions, for example) were more likely to be early discontinued (OR 1.40; 95% CI1.08-1.83), other risk factors for trial termination include: population including adults and seniors (OR 1.61; 95% CI 1.34-1.94), interventions using devices or procedures (OR 1.21; 95%CI 1.01-1.44) intervention models with single groups (OR 1.42 95%; CI 1.23-1.63). Conclusion: In this large and comprehensive analysis of trials registered in the ClinicalTrials.gov, early termination was observed in 5.4% from all clinical trials, with operational reasons, especially poor recruitment, being the most frequently reason leading to premature trial discontinuation. There is a need for better consideration on readiness and organization of the groups willing to develop clinical trials.