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【资讯翻译】EMA: PROPOSALS TO REVISE GUIDANCE ON FIRST-IN-HUMAN CLINICA...

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发表于 2016-7-26 09:27:32 | 显示全部楼层 |阅读模式

EMA: PROPOSALS TO REVISE GUIDANCE ON FIRST-IN-HUMAN CLINICAL TRIALS

The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to current guidance on first-in-human clinical trials to further improve strategies to identify and mitigate risks to trial participants. These changes are outlined in a new concept paper which has been released for public consultation. Comments on the proposals should be sent to FIH-rev@ema.europa.eu until 30 September 2016 using the form provided.

Clinical trials are essential for the development of medicines and without them patients cannot gain access to new potentially life-saving medicines. EU and international guidelines are in place to ensure that first-in-human clinical trials are conducted as safely as possible. These guidelines include the requirement for extensive studies, including in animals, to gather information about a medicine before it is given to humans.

The release of the concept paper is part of a review of the EMA guideline published in 2007 that provides advice on first-in-human clinical trials, in particular on the data needed to enable their appropriate design and allow the initiation of treatment in trial participants. This review identified those parts of the current guideline which need to be amended to take into account the evolution of practices in the conduct of these studies since the guideline was first published. The review also takes into account the lessons learnt from the tragic incident which took place during a Phase I first-in-human clinical trial in Rennes, France, in January 2016.

In recent years, the practice for conducting first-in-human clinical trials has evolved towards a more integrated approach, with sponsors conducting several steps of clinical development within a single clinical trial protocol (e.g. to assess single and multiple ascending doses, food interactions, or different age groups). This responds to the need for a structured approach to the conduct of these trials, with incremental decisions on next steps based on the data collected at each previous step. This enables an approach designed for the specificities of each medicine, its mechanism of action, and intended therapeutic use.

The concept paper, setting out the proposed changes to the guideline, was prepared by an EU-wide expert group that includes experts from the national competent authorities who authorise clinical trials in the EU and it was adopted by the Committee for Medicinal Products for Human Use (CHMP). It addresses the increased complexity of the protocols of first-in-human clinical trials.

This concept paper and the comments received from stakeholders will form the basis for an update of the guideline. A draft revised guideline is expected to be published before the end of 2016 for consultation.

Notes

In a single ascending dose trial, a single dose of the investigational medicine is given to each volunteer in a small group of clinical trial participants to assess the safety, if this is positive each participant in the next group receives a single dose at the next higher dose of the investigational medicine.

In multiple ascending dose trials, each subject is treated on multiple occasions (e.g. once a day for a week) at a given dose level. The treatment is then increased progressively to higher doses in successive groups of volunteers, provided the safety and tolerability at the previous dose is acceptable.

In the EU, the approval and conduct of clinical trials is within the remit of the relevant authorities of the European Member States.


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发表于 2016-7-26 10:36:08 | 显示全部楼层
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发表于 2016-7-26 13:54:25 | 显示全部楼层
欧洲药品管理局(EMA)提议修订首次人体临床试验指南

近日,欧洲药品管理局 (EMA)在与欧盟委员会和欧盟成员国(EU)的合作下,提议对目前首次在人体身上进行的临床试验进行进一步的完善,从而能够确定和减轻临床试验参与者的风险。这些更新已在向公众公布的一份新的概念性文件中进行概述。有关建议和意见可以使用建议中所提供的形式发到邮箱 FIH-rev@ema.europa.eu ,截止日期为2016年9月30日。

临床试验对于药物的开发来说是非常必要的,要是没有临床试验,患者就不可能获得可以潜在挽救生命的药物进行治疗。欧盟成员国和国际的指南都把首次在人体身上进行的临床试验的安全性放在首要位置。这些指南包含拓展研究的需要,包括在动物中进行的研究,在进行人体试验前搜集的药物相关信息。

公布的概念性文件是对EMA 2007发布的首次在人体临床试验的指南的部分回顾,尤其是那些数据要确保研究的设计恰当并让试验参与者能够开始初始治疗。自该指南首次发布以来,随着实施这些研究在实践中逐渐演化,本次回顾审查了现今指南考虑到需要修订的这些部分。该回顾还将从2016年1月发生在法国雷恩的 Phase I 期首次人体临床实验的悲惨事件中吸取教训。

近年来,首次人体试验的实施已经朝着综合性研究方向演变,即赞助商在单一的临床试验方案中进行几个步骤的临床开发(如评估单剂量和多个剂量递增作用,食物相互作用或不同年龄段的作用)。这就要求需要有一个结构性的方法来实施这些临床试验,随着基于各个先前步骤搜集来的数据进行下一步的增量决定。这使得研究设计需要有针对性的针对某个药,这个药物的药理机制以及该药未来的打算用途。

该概念性文件列明了针对先前指南修改的建议,这些建议是由欧盟成员国的各国家主管临床试验部门的专家组成的专家组编写,获得欧洲药品管理局(EMA)人用药品委员会(CHMP)的通过。它涉及了首次人体试验的增加的复杂协议。

此概念性文件和从从利益相关者收到的建议将构成更新的指南的基础。预计2016年年末将会公布该项指南的草案。
   
注意

在单剂量递增试验中,给予一小组临床试验参与者中的志愿者试验用单剂量药物以评估药物的安全性,如果在下一组接受单剂量药物的下一组更高剂量研究药物的每位参与者均为阳性结果。

在多剂量递增试验中,每位受试者在多个场合给予固定剂量进行治疗(如每日一次,持续一个星期)。治疗随后逐步提高到较高剂量在志愿者连续组,在先前剂量所提供的安全性和耐受性是可接受的。

在欧盟,临床试验的批准和实施是在欧盟成员国有关当局的职权范围之内。
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