Edited by:
Victoria Cornelius, PhD, Imperial College London, United Kingdom
Rachel Phillips, PhD, Imperial College London, United Kingdom
Trials is inviting submission of manuscripts, long and short, including original research and education articles for best practice in the collection, analysis and reporting of adverse events in randomised controlled trials.
Image credit: Rachel Phillips
We define clinical study reports (CSRs) as standardized full reports of the protocols, results, and other pertinent details of clinical studies that are typically submitted by pharmaceutical companies to regul...
The Review to this article has been published in Trials 2025 26:141
Clinical study reports (CSRs) are standardized full reports of the protocols, results, and other pertinent details of clinical studies that are typically submitted by pharmaceutical companies to regulatory aut...
The Review to this article has been published in Trials 2025 26:145
Adverse event (AE) collection is a key part of evidence generation in clinical trials and an integral element of safety reporting. AE assessment and documentation is particularly challenging in neonates who ar...
The field of digital mental health has followed an exponential growth trajectory in recent years. While the evidence base has increased significantly, its adoption within health and care services has been slow...
Despite Africa’s significant infectious disease burden, it is underrepresented in global vaccine clinical trials. While this trend is slowly reversing, it is important to recognize and mitigate the challenges ...
Randomised controlled trials (RCTs) are typically designed to determine beneficial intervention effects. In addition, an important aspect of every trial is to collect data on any potential harmful effects, wit...
Clinicians and researchers should consider the expected benefits and potential harms of an intervention. Parenting programmes are a widely used evidence-based intervention for child behaviour problems. However...
It is essential that electronic data collection (EDC) systems are both compliant with regulations and the principles of Good Clinical Practice (GCP) to allow for the timely and accurate reporting of data inclu...
Phase 1 clinical trials involve rigorous safety monitoring to identify any adverse effects of investigational treatments. There is growing evidence that healthy volunteers recruited in these studies may differ...
Adverse events suffer from poor reporting within randomised controlled trials, despite them being crucial to the evaluation of a treatment. A recent update to the CONSORT harms checklist aims to improve report...
Equity and health equity are fundamental pillars in fostering a just and inclusive society. While equity underscores fairness in resource allocation and opportunity, health equity aims to eradicate avoidable h...
The SAVVY project aims to improve the analyses of adverse events (AEs) in clinical trials through the use of survival techniques appropriately dealing with varying follow-up times and competing events (CEs). T...
Victoria Cornelius, PhD, Imperial College London, United Kingdom
Victoria Cornelius is a Professor in Medical Statistics and Trial Methodology and Director of Imperial Clinical Trials Unit. Victoria undertakes trial design research to evaluate drug and complex interventions with a focus on methods to increase statistical efficiency using both a Bayesian and frequentist framework. Her statistical research is in the use of time-to-event signal detection methods to identify adverse drug reactions, and approaches to improve the selection and presentation of harm information in randomised controlled trials. Victoria is passionate about translating best statistical practice into applied research and has collaborated and led on national research projects to improve the use of statistical methods in laboratory studies, feasibility trials, and early phase clinical trials research to support the translation of methods into practice.
Victoria has supervised both clinical and methodological NIHR fellows undertaking research in clinical trials. Projects include examining the use of Digital Health Interventions (DHI) to improve mental health, Methods to elicit prior distributions for trials in uncommon conditions, and the analysis of adverse events. Victoria has been a member of several funding committees including NIHR EME, Joint Global Health Trials Funding Committee, Welcome Trust specialist call for trials research and is currently a member of the NIHR Academy Doctoral fellowship board.
Rachel Phillips, PhD, Imperial College London, United Kingdom
Rachel Phillips is a Senior Lecturer in Medical Statistics and Clinical Trials at Imperial College London, and co-head of Statistics at Imperial Clinical Trials Unit (ICTU), School of Public Health. Rachel has worked in the area of clinical trials for over 10 years and has a broad range of experience in the design and analysis of clinical trials. Rachel's methodological research interests focus on the reporting and analysis of adverse events in clinical trials and the development of statistical methods to better identify adverse reactions. She is recognised both nationally and internationally for her work in this area and co-leads a harms theme for the MRC-NIHR Trials Methodology Research Partnership Outcomes Working Group.
Trials is inviting submission of manuscripts, long and short, including original research and education articles for best practice in the collection, analysis and reporting of adverse events in randomised controlled trials.
The design and analysis of randomised controlled trials has progressed considerably in the last decade. Assessing the harm of an intervention alongside its benefit is essential to enable practitioners and patients to make informed decisions for which intervention to use. While some progress has been made regarding assessing intervention harm, there is little evidence for any progress in implementing these approaches. These issues are typically less mature for the complex interventions. Though standard practice for analysis and reporting of adverse events remains rudimentary across all drug, device and complex intervention trials.
The aim of this special collection is to bring together best practice for collecting, analysing and presenting this complex adverse event data in reports of randomised controlled trials. We welcome articles that describe the specialised issues for harm outcome and ideally demonstrate through example how they can improve practice.
This Collection welcomes submission of research articles, long and short, including original research and education articles, opinion pieces, and commentaries.
Before submitting your manuscript, please ensure you have read our submission guidelines. Articles for this Collection should be submitted via our submission system, Editorial Manager. During the submission process you will be asked whether you are submitting to a Collection, please select "The collection, analysis and reporting of adverse events in randomised controlled trials" from the dropdown menu.
Articles will undergo the journal’s standard peer-review process and are subject to all of the journal’s standard policies. Articles will be added to the Collection as they are published.
The Guest Editors have no competing interests with the submissions which they handle through the peer-review process. The peer-review of any submissions for which the Guest Editors have competing interests is handled by another Editorial Board Member who has no competing interests.