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药品发现和开发中转译研究中的一些伦理问题。

A few ethical issues in translational research for medicinal products discovery and development.

机构信息

Unità di Bioetica, Istituto Superiore di Sanità, Rome, Italy.

Servizio di Coordinamento e Supporto alla Ricerca, Istituto Superiore di Sanità, Rome, Italy.

出版信息

Ann Ist Super Sanita. 2020 Oct-Dec;56(4):487-491. doi: 10.4415/ANN_20_04_11.

Abstract

The results obtained with basic research showing significant therapeutic promise are often not translated into clinical applications. The purpose of translational research is to favour the transition of basic research to application at the patient's bedside, and from here to routine clinical practice (without excluding the opposite pathway, in which the evidence generated by clinical practice helps to guide research). Although translational research can provide patients with valuable therapeutic resources, it is not risk-free. The most significant ethical issues in translational research on medicinal products derive from the risk of the intention to shorten the timeframes for the application of the results of the research making the scientific methods adopted and the regulatory requisites to be satisfied along the long path from the bench to the patient's bedside less rigorous. This is also relevant during pandemics when shortening the timeline from basic research to bedside is even more crucial. It is therefore necessary to establish defined and agreed requisites in order to guarantee the ethicality of translational research, by promoting the good of individuals and minimising the risks.

摘要

基础研究取得的具有显著治疗前景的结果往往未能转化为临床应用。转化研究的目的是促进基础研究向患者床边的应用转化,再从这里转化为常规临床实践(也不排除相反的途径,即临床实践产生的证据有助于指导研究)。虽然转化研究可以为患者提供有价值的治疗资源,但它并非没有风险。药物转化研究中最重要的伦理问题源于缩短研究结果应用时间的意图,使得从实验室到患者床边的漫长道路上采用的科学方法和监管要求变得不那么严格。在大流行期间,从基础研究到床边的时间缩短更为关键,这一点也同样相关。因此,有必要建立明确和商定的要求,通过促进个人利益和最小化风险来保证转化研究的伦理性。

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