This article describes three tools that could facilitate conversations between researchers and patients and other stakeholders about the choice of intercurrent event strategy for estimands: (i) a video explaining the concept of an estimand and the five different ways that intercurrent events can be incorporated into the estimand definition; (ii) an infographic outlining these five strategies; and (iii) an editable PowerPoint slide which can be completed with trial-specific details to facilitate conversations around choice of estimand for a particular trial.

This proof-of-concept study re-analysed two previous SWATs using Bayesian methods and ACCEPT analyses. It identified Bayesian methods and ACCEPT analyses offer solutions to challenges experienced in the analysis and interpretation of SWATs.

This article provides an approach for selecting intercurrent event strategies, which systematically considers the trade-off between relevance (whether it addresses a useful question) and reliability (the ability to be estimated such that stakeholders can have confidence in the results) of each strategy in order to identify those that can be used to robustly inform decision-making.

This review identifies the current application of the estimand framework specifically to trials with an adaptive design.

This paper describes a tool explaining the 5 attributes of an estimand, accessibly referred to as the 5 pillars of the research question. This was co-developed for researchers and public partners to use to facilitate the involvement of public partners in devising estimands.

This paper proposes using the posterior probability of noninferiority to demonstrate the value of undertaking an NI trial using a credible NI margin. A five-part Bayesian framework is described: the data generation/analysis model; maximum feasible sample size; different potential outcomes; primary NI margin; and plausible priors.

A review of original research protocols submitted to the United Kingdom’s Health Research Authority, which oversees ethical review of clinical trials, to identify how the use of estimands has changed over time, whether trials are using estimands correctly (i.e. correctly defining the five attributes of an estimand), and which strategies are being used to handle intercurrent events.

Patient and Public Involvement (PPI) is well-established in applied health research but remains under utilised in statistical methodology research due to perceived irrelevance and communication challenges. This paper summarises a one-day workshop held in February 2024 in Leicester, organised by the University of Leicester and the NIHR Statistics Group, aimed at addressing barriers to meaningful PPI in statistical methodology.

In a 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.

Many trials are affected by unforeseen events after recruitment has commenced. The aim of this study is to explore a hypothetical strategy for dealing with an intercurrent event that occurred during trial follow-up; COVID-19 restrictions. Analysis was conducted using multiple imputation.