Background and Aims A Study Within A Trial (SWAT) is a research study embedded within a larger trial which aims to investigate different strategies for a particular trial process, such as trial recrui...

While the use of estimands in randomized trials is increasing, there is little guidance on which intercurrent event strategies should be used. The article by Fleming et al. seeks to address this gap....

Background Randomised controlled trials (RCTs) are the gold standard for evaluating treatment effects, with the results informing policy and clinical practice. To ensure appropriate methods are utilis...

Background Randomised controlled trials (RCTs) are the gold standard for evaluating treatment effects, with the results informing policy and clinical practice. To ensure appropriate methods are utilis...

Background An estimand is a precise description of the treatment effect a trial is aiming to find out. We previously identified that public partners (defined as patients and/or members of the public w...

PhD Project - Optimising the choice of estimand in randomised trials: developing guidance on balancing statistical and clinical considerations to ensure results matter to stakeholders at University Co...

Non-inferiority (NI) trials typically require larger sample sizes than superiority comparisons. This is problematic for uncommon conditions where recruitment is restricted. When a power calculation re...

The most powerful, simple and trusted way to gather experience data. Start your journey to experience management and try a free account today.

Background The use of estimands in clinical trials was formalised with the adoption of the final International Conference on Harmonisation E9 Addendum on Estimands and Sensitivity Analysis in Clinical...

Under a composite estimand strategy, the occurrence of the intercurrent event is incorporated into the endpoint definition, for instance by assigning a poor outcome value to patients who experience th...

Please note that job descriptions are not exhaustive, and you may be asked to take on additional duties that align with the key responsibilities ment...

When patients stop taking their assigned treatment in a clinical trial - whether due to side effects, lack of effectiveness, or personal choice - researchers often still want to understand how that treatment...

To systematically investigate trustworthiness (methodological rigor, transparency, good governance, research integrity, and absence of misconduct) in randomized controlled trials (RCTs) of osteopathic...

Please note that job descriptions are not exhaustive, and you may be asked to take on additional duties that align with the key responsibilities ment...

Background The coronavirus pandemic (Covid-19) presents a variety of challenges for ongoing clinical trials, including an inevitably higher rate of missing outcome data, with new and non-standard reas...

Background Classical approaches to subgroup analysis in randomised controlled trials (RCTs) to identify heterogeneous treatment effects (HTEs) involve testing the interaction between each pre-specifie...

Reference-based multiple imputation provides a practical information anchored tool for inferences about the treatment effect for a treatment policy estimand with a longitudinal binary outcome. The latent multivariate normal model is the preferred implementation.

This report presents the explanation and elaboration paper for the CONSORT (Consolidated Standards of Reporting Trials) 2010 and SPIRIT (Standard Protocol Items: Recommendations for Interventional Tri...

Introduction In clinical trials, a treatment policy strategy is often used to handle treatment nonadherence. However, estimation in this context is complicated when data are missing after treatment .....

Longitudinal studies are frequently used in medical research and involve collecting repeated measures on individuals over time. Observations from the same individual are invariably correlated and thu....

Putting contemporary clinical trials methodology into practice. Do you work in clinical trials and want to find out about the latest in the design and delivery of contemporary trials? Join us for ses...