药品的同情使用：法律规定和伦理挑战。
Compassionate use of unauthorized drugs: Legal regulations and ethical challenges.
机构信息
Centre for Studies on Research Integrity, Institute of Law Studies, Polish Academy of Sciences, Nowy Świat 72, 00-330 Warsaw, Poland; Department of Clinical Immunology, Medical University of Warsaw, Nowogrodzka Str. 59, 02-006 Warsaw, Poland.
Department of Clinical Immunology, Medical University of Warsaw, Nowogrodzka Str. 59, 02-006 Warsaw, Poland; Laboratory of Bacteriophages, Ludwik Hirszfeld Institute of Immunology and Experimental Therapy, Polish Academy of Sciences, Rudolfa Weigla Str. 12, 53-114 Wrocław, Poland.
出版信息
Eur J Intern Med. 2019 Jul;65:12-16. doi: 10.1016/j.ejim.2019.04.008. Epub 2019 Apr 26.
Compassionate use (also referred to as expanded access) is therapeutic use of unauthorized drugs outside of clinical trials. The objective of this review is to discuss practical aspects of the current legal regulations concerning compassionate use that have been introduced in the European Union, the USA (both the Food and Drug Administration regulations and Right-to-try laws), Canada and Australia. We also present main ethical challenges associated with use of unauthorized drugs such as possible difficulties with obtaining informed consent and fair patient selection. Moreover, we discuss guidelines, especially those contained in the Declaration of Helsinki, which may aid doctors in the ethical conduct of compassionate treatments.
同情用药（也称为扩展准入）是指在临床试验之外使用未经批准的药物进行治疗。本综述的目的是讨论当前在欧盟、美国（食品和药物管理局法规和尝试权法）、加拿大和澳大利亚引入的关于同情用药的现行法律规定的实际方面。我们还介绍了与使用未经批准的药物相关的主要伦理挑战，例如在获得知情同意和公平选择患者方面可能遇到的困难。此外，我们还讨论了指导方针，特别是《赫尔辛基宣言》中包含的指导方针，这些指导方针可能有助于医生在进行同情治疗时遵守伦理规范。
Zotero 插件