Transition to the EU Clinical Trials Regulation: Trick or treat?

Q2 Health Professions

Medical Writing Pub Date : 2023-03-15 DOI:10.56012/wfqf7348

I. Turek

引用次数: 0

Abstract

The etiquette in clinical trial research requires companies to respect rules and to be precise and accurate. The new EU Clinical Trials Regulation 536/2014 (EU CTR) pushes companies and health authorities one step further – to be more flexible and collab orative. The EU CTR aims to harmonise clinical trial applications in the EU, bring more innovation to Europe, and enable faster approval of clinical trials. However, the novel process of clinical trial application in its early stages is fraught with technical and logistic challenges.

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向欧盟临床试验法规过渡:不给糖就捣蛋?

临床试验研究的礼仪要求公司尊重规则，做到精确准确。新的欧盟临床试验条例536/2014 (EU CTR)推动公司和卫生当局更进一步——更加灵活和协作。欧盟CTR旨在协调欧盟的临床试验申请，为欧洲带来更多创新，并使临床试验获得更快的批准。然而，临床试验申请的新流程在其早期阶段充满了技术和后勤挑战。

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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来源期刊

Medical Writing Health Professions-Medical Terminology

CiteScore

0.40

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0.00%

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期刊介绍： Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.