La formación científico-investigativa: proceso indispensable para el desarrollo de los ensayos clínicos en una institución de salud / The scientific-investigative training:indispensable process for the development of the clinical assays in a health institution

En Cuba, los investigadores clínicos como profesionales de las ciencias médicas, ejecutan las investigaciones científicas relacionadas con los procesos salud-enfermedad. De ahí que resulta necesario determinar la verdadera dimensión que alcanza la formación científico - investigativa de dichos profesionales. A tales efectos, se realizó el presente estudio en el cual se exponen algunas ideas en torno a un proceso imprescindible en los momentos actuales de desarrollo de la investigación clínica, donde la sistematización formativa constituye el elemento fundamental de la formación de estos profesionales.

In Cuba, the clinical researchers as professionals of the medical sciences, carry out the scientific investigations related to the health-disease processes. So that, it is necessary to determine the true dimension that reaches the scientist - investigative training of these professionals. To fulfil this objective, the present study was carried out in which some ideas are exposed regarding an indispensable process in the current moments of the clinical investigation development, where the formative systematization constitutes the fundamental element in training these professionals.

Antecedentes en la formación del investigador en ciencias médicas y la evolución de los ensayos clínicos en Cuba / Historical background in the investigator's training on medical sciences and the development of the clinical trials in Cuba

Desde sus inicios, en Cuba se le ha otorgado gran importancia a los ensayos clínicos. El gobierno ha dedicado innumerables recursos para el desarrollo de la industria biofarmacéutica y la obtención de nuevos productos farmacológicos empleados para tratar disímiles enfermedades. Debido a la relevancia científica y la ética que poseen estos ensayos clínicos, resulta necesario que sean conducidos por profesionales con una calificación científica apropiada. Ante tal situación, ha sido necesario formar a dichos profesionales desde los puntos de vista científico e investigativo. Por ello, en este artículo se exponen elementos relacionados con los antecedentes históricos de esa formación y su dinámica como un primer acercamiento al tema tratado.

Since their beginnings, great importance has been granted to the clinical trials in Cuba. The government has dedicated countless resources for the development of biopharmaceutical industry and the elaboration of new pharmacological products for treating different illnesses. Due to the scientific relevance and the ethics of these clinical trials, it is necessary that are conducted by professionals with an appropriate scientific qualification. In such a situation, it has been necessary to train these professionals from the scientific and investigative points of view. That is why, elements related with the historical background of that training and its dynamics are exposed in this work, as a first approach to the treated topic.

Discussion on the Role Conversion and Difference of the Clinicians and Clinical Investigator / 中国医学伦理学

Clinical research differs from routine diagnosis and treatment,and the clinicians and clinical investi-gators differ due to their different responsibilities.From the aspects of personnel qualification requirements,activity implementation process and role conflict balance in clinical research and routine diagnosis and treatment work,this paper compared and analyzed the roles of clinicians and clinical investigators and differences,deepening clini-cians'understanding and grasping on the connotation of their different roles,enhancing the sense of responsibility of clinicians as clinical investigators and improving the quality of clinical research.

Analysis and countermeasures of demands investigation on ethical review knowledge training among clinical investigators / 中华医学科研管理杂志

Objective To investigate and analyze the demands of ethical review knowledge training among clinical investigators and determinants,thus to discuss countermeasures to optimize the training pattern of ethical review knowledge training among clinical investigators and to provide scientific evidence and proposals for training management.Methods A total of 366 clinical investigators from third-class and first-grade general hospitals in Beijing were surveyed by questionnaires according to stratified random sampling method based on the professional titles,and the results were analyzed by SPSS 20.0.Results There existed training demands of ethical review knowledgeamong clinical investigators.For investigators with primary and intermediate titles,knowledge training about informed consent process,subject safety and rights protection,and principles of privacy security were highly needed.The training patterns researched were mainly short-term training and lectures organized by administrative department of the hospital.Most investigators expressed that the primary influence factor of training was lack of time and effort.Conclusions Based on the results of the survey,the demands of ethical review knowledge training are analyzed and countermeasures to optimize and enrich current training patterns are discussed,to improve the efficiency of training and the recognition and knowledge of ethical review among clinical investigators.