临床试验授权:更好地评估欧洲新法规的最后回顾。

IF 1.4 Q4 PHARMACOLOGY & PHARMACY Reviews on recent clinical trials Pub Date : 2023-01-01 DOI:10.2174/1574887118666230320124012
Stéphane Vignot, Gaelle Guyader, Valérie Salomon, Philippe Vella, Isabelle Yoldjian, Patrick Maison, Christelle Ratignier-Carbonneil
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引用次数: 0

摘要

新的《欧洲临床试验条例》于2022年1月31日实施,是促进欧洲临床研究的重要一步。法国国家药品和保健品安全局(ANSM)建议分享2017年启动的《条例》应用准备的一些关键方面,并讨论应考虑的共享指标,以监测一个地区在患者获得创新和赞助商吸引力方面的临床试验机会。基于从首次申请授权到首次纳入的时间的新标准对评估《欧洲临床试验条例》的实施可能特别有意义。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Clinical Trial Authorisation: A Final Look Back to Better Appraise the New European Regulation.

The implementation of the new European Clinical Trial Regulation on 31 January 2022, is a major step to promote clinical research in Europe. The French National Agency for Medicines and Health Products Safety (ANSM) proposes to share some key aspects of the preparation for the application of the Regulation initiated in 2017 and to discuss shared indicators that should be considered to monitor clinical trials opportunities on a territory with regards to access to innovation for patients and attractiveness for sponsors. New criteria based on the time from the first request for authorisation to the first inclusion could be of particular interest to appraise the implementation of the European Clinical Trial Regulation.

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来源期刊
Reviews on recent clinical trials
Reviews on recent clinical trials PHARMACOLOGY & PHARMACY-
CiteScore
3.10
自引率
5.30%
发文量
44
期刊介绍: Reviews on Recent Clinical Trials publishes frontier reviews on recent clinical trials of major importance. The journal"s aim is to publish the highest quality review articles in the field. Topics covered include: important Phase I – IV clinical trial studies, clinical investigations at all stages of development and therapeutics. The journal is essential reading for all researchers and clinicians involved in drug therapy and clinical trials.
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