Good clinical practices in research By Humberto Reynales MD, MSc, PhD Good Clinical Practice in Research or GCP Good Clinical Practice for its acronym in English is the training par excellence in clinical research. We have all done one of these trainings at some point, either in person or virtual depending on the moment and…
Buenas prácticas clínicas en investigación o GCP Good Clinical Practice por sus siglas en inglés es el entrenamiento por excelencia en investigación clínica. Todos hemos realizado en algún momento uno de estos entrenamientos, ya sea presencial o virtual dependiendo del momento y la urgencia de hacerlo. Este es el entrenamiento requerido por todos, agencias, patrocinadores y CROs, y no hay duda que contiene la esencia de cómo se debe conducir un estudio cínico.
Importance of patient registration and data collection It is frequent to hear from different sources that the epidemiological data with which decisions are made in public health policies in Colombia present deficiencies that do not ensure the validity of their information. However, this is not only a Colombian problem but rather an international one where…
Ethics in Clinical Research Dr. Humberto Reynales MD. MSc. PhD Ethics are one and must be lived consistently, regardless of the place or time of the situation. In ethics there should be no gray tones: one is ethical or not. You cannot be ethical at times or when it is convenient or not convenient.…
¿The first clinical trial? Dr. Humberto Reynales MD. MSc. PhD ¿What is the first known clinical trial? It is said that of James Lind in 1753 in which the treatment for scurvy was evaluated in a group of sailors. However, there is information about what could be considered the first «clinical trial» and found…
Es frecuente escuchar de diferentes fuentes que los datos epidemiológicos con que se toman decisiones en políticas de salud pública en Colombia presentan deficiencias que no aseguran la validez de su información. Sin embargo, este no es solo un problema colombiano sino más bien internacional en donde la falta de información de los pacientes y su calidad, limita el conocimiento y la investigación. Este no es un problema nuevo, ya la OMS en su informe de salud Mundial del 2003 resaltaba la importancia de utilizar métodos sistemáticos para el bienestar de cada país:
Academic Research Organizations in Latin America Dr. Jhonny Beltrán This text constitutes the personal opinion of the author, issued based on his experience and his interpretation of bibliographic sources. Academic Research Organizations -ARO- (Academic Research Organizations) could be defined as those that have the human and technological resources that allow them to face specific…
The meaning of Clinical Research in a developing country Dra. Constanza Rubio The word science is derived from scientĭa which in Latin means knowledge, and its objectives are to generate hypotheses, deduce principles and elaborate laws. For this, a research method is established that raises criteria adjusted to reality and ensures permanent correction of…
Colombian regulation for clinical studies By Marta Faccini The Colombian Regulation for clinical studies began in 1993 with the issuance of Resolution No. 008430 of 1993 «by which the scientific, technical and administrative standards are established as requirements for the development of research activity in health» and which defines the following points: Institutions that…
En especial, desde la publicación del informe To Err is Human, en 1999, la gestión del riesgo ha sido considerada un tema prioritario en la formulación de la política sanitaria, la dirección de las instituciones y la operación de los procesos. Conocer el volumen y la gravedad de los eventos adversos relacionados con la atención en salud ha motivado la atención de: La sociedad, los prestadores de salud,