Debate about appropriate gatekeeping for access to investigational drugs outside clinical trials has intensified in recent years, culminating in the enactment of the federal “Right to Try” Act in May 2018 and similar laws in 41 states.^1,2 The premise of Right to Try is that regulatory bodies should not be party to doctor-patient decisions about how to respond to life-threatening disease, even when those decisions involve unapproved products.³ This contrasts with the longstanding pathway known as “Expanded Access”, which requires that pre-approval access be authorized by the US Food and Drug Administration (FDA) and institutional review boards.⁴ For both pathways, patients may access investigational drugs only if the manufacturer agrees to provide them.

中文翻译：

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尝试权和肿瘤学家的看门义务。

近年来，有关在临床试验之外获得研究药物的适当门禁的争论日益加剧，最终导致了2018年5月颁布的联邦“尝试权”法和41个州的类似法律。^1,2 “尝试权”的前提是，即使在涉及未经批准的产品的情况下，监管机构也不应成为医患决策的当事方。³这与被称为“扩展访问权”的长期途径形成了鲜明对比，后者要求美国食品药品管理局（FDA）和机构审查委员会对批准前的访问权进行授权。⁴对于这两种途径，只有在制造商同意提供治疗药物的情况下，患者才可以使用研究药物。