Blockchain as a Prime Guardian: Securing Clinical Trial Data Integrity.

IF 1.4 Q4 PHARMACOLOGY & PHARMACY
Nikhil Sethi, Charul Rathore, Dilpreet Singh
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引用次数: 0

Abstract

The present study focuses on the possible use of the emerging technology of blockchain in ensuring data management security in clinical trials. With the determination of the chief researchers and clinical investigations becoming more and more complex and international, achieving data quality and integrity, transparency, and legal compliance becomes imperative. By offering a distributed and immutable time-stamped ledger, issues of data revisions, selective data release, and the usually time-consuming issue of compliance auditing are well addressed. With this technology, it is possible to conduct surveillance of multi-center studies without compromising the confidentiality of patients while allowing the researchers to have unbiased information. When it comes to internal accountability, the use of the blockchain will create a situation whereby no alteration of the documents will take place. Thus, regulatory oversight is improved with the engagement of these parties. In addition, it makes sure that the need for bias in the reporting of outcomes is avoided in all trials and all results reported whether positive or negative. In order to address clinical trial data management and clinical trial outcomes' validity and reliability, this review provides reputation management through digital ledger technology in the real world.

区块链作为主要守护者:确保临床试验数据的完整性。
本研究的重点是在确保临床试验数据管理安全方面可能使用的区块链新兴技术。随着首席研究人员的决心和临床研究变得越来越复杂和国际化,实现数据质量和完整性、透明度和法律合规变得势在必行。通过提供分布式且不可变的时间戳分类账,可以很好地解决数据修订、选择性数据发布以及通常耗时的遵从性审计问题。有了这项技术,可以在不损害患者机密的情况下对多中心研究进行监测,同时使研究人员能够获得公正的信息。在内部问责制方面,使用区块链将创造一种不会对文件进行更改的情况。因此,随着这些各方的参与,监管监督得到了改善。此外,它确保在所有试验中避免报告结果的偏倚,所有报告的结果无论阳性还是阴性。为了解决临床试验数据管理和临床试验结果的有效性和可靠性问题,本综述通过数字分类账技术在现实世界中提供了声誉管理。
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
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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