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Trials that turn from retrospectively registered to prospectively registered: a cohort study of "retroactively prospective" clinical trial registration using history data.从回顾性注册转向前瞻性注册的试验：使用历史数据的“回顾性前瞻性”临床试验注册队列研究。
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4
Correction: Analysis of clinical trial registry entry histories using the novel R package cthist.更正：使用新型R包cthist对临床试验注册条目历史进行分析。
PLoS One. 2023 Oct 24;18(10):e0292761. doi: 10.1371/journal.pone.0292761. eCollection 2023.
5
An observational study on the adherence to study registrations in German interventional and observational studies from various fields.一项关于德国各领域介入性和观察性研究中对研究注册的依从性的观察性研究。
PeerJ. 2023 Sep 25;11:e16015. doi: 10.7717/peerj.16015. eCollection 2023.

本文引用的文献

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How informative were early SARS-CoV-2 treatment and prevention trials? a longitudinal cohort analysis of trials registered on ClinicalTrials.gov.早期 SARS-CoV-2 治疗和预防试验有多大信息量？对 ClinicalTrials.gov 上注册的试验进行的纵向队列分析。
PLoS One. 2022 Jan 21;17(1):e0262114. doi: 10.1371/journal.pone.0262114. eCollection 2022.
2
How we learnt to stop worrying and love web scraping.我们如何学会不再担忧并爱上网络爬虫。
Nature. 2020 Sep;585(7826):621-622. doi: 10.1038/d41586-020-02558-0.
3
Prospective registration and reporting of trial number in randomised clinical trials: global cross sectional study of the adoption of ICMJE and Declaration of Helsinki recommendations.前瞻性注册和报告随机临床试验编号：对 ICMJE 和赫尔辛基宣言建议采用情况的全球横断面研究。
BMJ. 2020 Apr 14;369:m982. doi: 10.1136/bmj.m982.
4
How to avoid common problems when using ClinicalTrials.gov in research: 10 issues to consider.在研究中使用 ClinicalTrials.gov 时如何避免常见问题：需要考虑的 10 个问题。
BMJ. 2018 May 25;361:k1452. doi: 10.1136/bmj.k1452.
5
Harms of outcome switching in reports of randomised trials: CONSORT perspective.随机试验报告中结果转换的危害：CONSORT观点。
BMJ. 2017 Feb 14;356:j396. doi: 10.1136/bmj.j396.
6
Changes to registration elements and results in a cohort of Clinicaltrials.gov trials were not reflected in published articles.注册要素的变化以及 Clinicaltrials.gov 试验队列的结果并未反映在已发表的文章中。
J Clin Epidemiol. 2016 Feb;70:26-37. doi: 10.1016/j.jclinepi.2015.07.007. Epub 2015 Jul 29.
7
World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.《世界医学协会赫尔辛基宣言：涉及人类受试者的医学研究伦理原则》
JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053.
8
Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.随机试验中结果选择性报告的实证证据：方案与已发表文章的比较。
JAMA. 2004 May 26;291(20):2457-65. doi: 10.1001/jama.291.20.2457.

使用新型 R 包 cthist 分析临床试验注册库条目历史记录。

Analysis of clinical trial registry entry histories using the novel R package cthist.

机构信息

Berlin Institute of Health at Charité - Universitätsmedizin Berlin, QUEST Center for Responsible Research, Berlin, Germany.

出版信息

PLoS One. 2022 Jul 1;17(7):e0270909. doi: 10.1371/journal.pone.0270909. eCollection 2022.

DOI:10.1371/journal.pone.0270909
PMID:35776915
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9249399/
Abstract

Historical clinical trial registry data can only be retrieved by manually accessing individual clinical trials through registry websites. This limits the feasibility, accuracy and reproducibility of certain kinds of research on clinical trial activity and presents challenges to the transparency of the enterprise of human research. This paper presents cthist, a novel, free and open source R package that enables automated scraping of clinical trial registry entry histories and returns structured data for analysis. Documentation of the implementation of the package cthist is provided, as well as 3 brief case studies with example code.

摘要

历史临床试验注册数据只能通过手动访问注册网站上的各个临床试验来检索。这限制了某些类型的临床试验活动研究的可行性、准确性和可重复性，并对人类研究企业的透明度提出了挑战。本文介绍了 cthist，这是一个新颖的、免费的开源 R 包，它可以自动抓取临床试验注册条目历史记录，并返回用于分析的结构化数据。提供了对 cthist 包实现的文档说明，以及 3 个带有示例代码的简短案例研究。