Trials special series - the collection, analysis and reporting of adverse events in randomised controlled trials
File(s)
Published version
OA Location
Author(s)
Phillips, Rachel
Cornelius, Victoria
Type
Journal Article
Abstract
Background
While the design and analysis of randomised controlled trials has progressed rapidly in the last decade, the analysis of harm outcomes has seen minimal change [1,2,3]. Integral to assessing harm is what and how data is collected. Considerations of all these aspects vary across the different types of interventions e.g. pharmaceutical, surgical, behavioural etc. While there has been an increase in research to progress how data should be collected, synthesised and reported for harm outcomes, there is little evidence of progress in implementing these approaches and the analysis and reporting of harm outcomes remains rudimentary [3].
In this special series, Trials invited submissions that related to the collection, analysis and reporting of adverse events in clinical trials. To date twelve articles have been published in the series. In this editorial, we summarise each of these submissions and briefly discuss the implications on applied clinical trials and future methodological research.
While the design and analysis of randomised controlled trials has progressed rapidly in the last decade, the analysis of harm outcomes has seen minimal change [1,2,3]. Integral to assessing harm is what and how data is collected. Considerations of all these aspects vary across the different types of interventions e.g. pharmaceutical, surgical, behavioural etc. While there has been an increase in research to progress how data should be collected, synthesised and reported for harm outcomes, there is little evidence of progress in implementing these approaches and the analysis and reporting of harm outcomes remains rudimentary [3].
In this special series, Trials invited submissions that related to the collection, analysis and reporting of adverse events in clinical trials. To date twelve articles have been published in the series. In this editorial, we summarise each of these submissions and briefly discuss the implications on applied clinical trials and future methodological research.
Date Issued
2025-05-12
Date Acceptance
2025-05-01
Citation
Trials, 2025, 26 (1)
ISSN
1745-6215
Publisher
BMC
Journal / Book Title
Trials
Volume
26
Issue
1
Copyright Statement
© The Author(s) 2025. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
License URL
Identifier
10.1186/s13063-025-08861-3
Publication Status
Published
Article Number
152
Date Publish Online
2025-05-12