Factores asociados con la participación de pacientes en ensayos clínicos en cáncer

Abstract

BackgroundCancer clinical trials require the voluntary participation of patients for their adequate development. Not all patients wish to do this, thus affecting their development. In other studies, the most important identified reasons in that influence the decision have been lack of information about study design, randomisation methods, and kind of treatment, use of placebos, toxicity, and side effects of the investigational medicinal product. ObjectiveTo evaluate the volition to participate in clinical trials, as well as to establish the reasons associated with this in a sample of patients. MethodsA cross-sectional observational study was conducted on a sample of cancer patients. This included a logistic regression analysis, taking the volition to participate in clinical trials as the dependent variable, along with a group of explanatory variables. ResultsA total of 366 patients were interviewed. Although 84% did not know about clinical trials, 63% were willing to participate. The reasons the remaining percentage gave for declining to participate were fear, lack of information about risks and benefits, rights, and informed consent. ConclusionAdditional studies are required to identify the reasons associated with participation in cancer clinical trials. Furthermore, strategies are required for improving the information and communication for patients to take part in clinical trials.