用于临床试验招募预测和招募监测的免费软件:系统综述

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
Philip Heesen , Malgorzata Roos
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引用次数: 0

摘要

背景临床试验的成功完成最终取决于切合实际的招募预测。世界各地的研究人员在设计临床试验时,可以常规使用免费开源软件中的招募预测统计方法。方法两位独立审稿人按照 PRISMA 指南进行了系统性综述。符合条件的文章包括以招募预测和监测统计方法为重点的英文出版物,其中提到了软件的实施。通过对符合条件的文章所提供的参考文献进行回溯,丰富了从完善的数据库中检索到的文章列表。结果我们找到了 21 篇符合条件的文章,其中 7 篇(33%)提供了可免费获取的软件。最终,只有一篇文章提供了通俗易懂、文档齐全且目前可直接使用的免费开源软件链接。缺乏可用性的主要原因是访问受阻和链接过时。这些结果突出表明,今后需要努力实现免费获取文档齐全的软件实现,以支持研究人员在临床试验中例行使用统计方法得出切合实际的招募预测结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Freely accessible software for recruitment prediction and recruitment monitoring of clinical trials: A systematic review

Background

The successful completion of clinical trials ultimately depends on realistic recruitment predictions. Statistical methods for recruitment prediction implemented in a free-of-charge open-source software could be routinely used by researchers worldwide to design clinical trials. However, the availability of such software implementations is currently unclear.

Methods

Two independent reviewers conducted a systematic review following PRISMA guidelines. Eligible articles included English publications focused on statistical methods for recruitment prediction and monitoring that referred to software implementations. The list of articles retrieved from well-established data bases was enriched by backtracking of references provided by eligible articles. The current software availability and open-source status were tabulated.

Results

We found 21 eligible articles, 7 of which (33 %) provide freely accessible software. Ultimately, only one article provides a link to an easy-to-comprehend, well-documented, and currently directly applicable free-of-charge open-source software. The lack of availability is mainly caused by blocked access and outdated links.

Conclusions

While several software implementations exist for recruitment prediction, only a small fraction is freely accessible. These results highlight the need for future efforts to achieve free access to well-documented software implementations supporting researchers in routinely using statistical methods to arrive at realistic recruitment predictions in clinical trials.

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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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