Osorio Lyda
Grupo de Epidemiología y Salud Poblacional, Escuela de Salud Pública, Facultad de Salud, Universidad del Valle.
Biomedica. 2015 Apr-Jun;35(2):274-84. doi: 10.1590/S0120-41572015000200016.
An increasing number of countries are adopting good clinical practices guidelines as part of the regulation of clinical studies to register pharmaceutical products and other health-related products. Consequently, all parties involved in the research and development of these products should know them, implement them and ensure their compliance. However, good clinical practices guidelines are just one of the initiatives seeking to achieve the highest ethical and scientific standards in health research and in other areas where humans are research subjects. This review defines such practices and their objectives presenting in a practical manner their legal framework in Colombia, and clarifying their application in studies where interventions use no medications or those that are not clinical trials. Finally, the work discusses the challenges to ensure that good clinical practices contribute to the protection of research participants, the education of trustworthy health professionals, and a culture of respect for human beings.
越来越多的国家采用良好临床实践指南，将其作为临床研究监管的一部分，以对药品及其他健康相关产品进行注册。因此，参与这些产品研发的所有各方都应了解、实施并确保遵守这些指南。然而，良好临床实践指南只是旨在在健康研究以及以人类为研究对象的其他领域实现最高伦理和科学标准的举措之一。本综述对这些实践及其目标进行了定义，以实际方式介绍了其在哥伦比亚的法律框架，并阐明了其在干预措施不使用药物或不属于临床试验的研究中的应用。最后，本文探讨了确保良好临床实践有助于保护研究参与者、培养值得信赖的健康专业人员以及营造尊重人类的文化所面临的挑战。
