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临床试验注册:实践视角

Clinical trial registration: A practical perspective.

作者信息

Bhaskar S Bala

机构信息

Department of Anaesthesiology, VIMS, Ballari, Karnataka, India.

出版信息

Indian J Anaesth. 2018 Jan;62(1):10-15. doi: 10.4103/ija.IJA_761_17.

Abstract

The increase in the number of clinical trials, driven mainly for career advancement mandated by regulatory bodies such as Medical Council of India risks output of substandard publications and also wastage of resources. There are also concerns of inadequate reporting and wilful concealment of results. The quality and quantity of the output become questionable evidences for medical practice. Lack of transparency can lead to disillusionment of the public in the medical field. Clinical trials registration seeks to regulate and streamline the clinical trials by mandating registration in various registries, through free for registration sites such as Clinical Trials Registry of India (CTRI). The guidelines are based on the World Health Organisation's International Clinical Trials Registry Platform (ICTRP). This review aims to highlight the types of registries, the registration process, the data that need to be registered, the guide to use the CTRI and the search options in CTRI and ICTRP. The role of International Committee of Medical Journal Editors is also highlighted in regard to not only registration but also on the publication of trial registration number in the manuscript.

摘要

临床试验数量的增加主要是受印度医学委员会等监管机构规定的职业发展驱动,这有可能产生不合格的出版物,还会造成资源浪费。人们还担心报告不充分以及故意隐瞒结果。产出的质量和数量成为医学实践中值得怀疑的证据。缺乏透明度可能导致公众对医学领域的幻想破灭。临床试验注册旨在通过要求在各种注册机构进行注册来规范和简化临床试验,通过印度临床试验注册中心(CTRI)等免费注册网站进行。这些指南基于世界卫生组织的国际临床试验注册平台(ICTRP)。本综述旨在突出注册机构的类型、注册过程、需要注册的数据、使用CTRI的指南以及CTRI和ICTRP中的搜索选项。还强调了国际医学期刊编辑委员会在不仅注册方面,而且在手稿中公布试验注册号方面的作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6660/5787884/d602f9078adc/IJA-62-10-g003.jpg

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