Simulation studies are commonly used in methodological research for the empirical evaluation of data analysis methods. They generate artificial datasets under specified mechanisms and compare the p...

Clinical trials are becoming increasingly complex, incorporating numerous parameters and degrees of freedom. Optimal analytic approaches for these intricate trial designs are often unavailable, neces....

Background Adaptive designs are increasingly being used in clinical trials within diverse clinical areas. They can offer advantages over traditional non-adaptive approaches, including improved efficiency and patient benefit. The level of improvement observed in practice depends to a large degree on conducting interim analyses (at which adaptations can be made to the trial based on collected data) rapidly and to a high standard. Methods The ROBust INterims for adaptive designs (ROBIN) project aimed to identify best practice for conducting high-quality and rapid interim analyses. This was done through evidence synthesis of published work, qualitative research with trial stakeholders working at public sector clinical trials units, engagement with patients and the public, and a meeting of trial stakeholders to discuss findings and agree recommendations. Results This paper provides recommendations for teams that conduct adaptive trials about how to ensure interim analyses are done rapidly and to a high standard. We break down recommendations by stage of the trial. We also identify a lack of methodology on how best to involve patients in adaptive trials and related decision-making. A limitation of our recommendations is that the research was mostly focused on UK academic settings, although we believe much of the recommendations are relevant in other countries and to industry-sponsored trials. Conclusions When following the recommendations outlined in this paper, the process of planning and executing interim analyses will be smoother; in turn, this will lead to more benefits from using adaptive designs.

This Special Communication introduces the Transparent Reporting of Observational Studies Emulating a Target Trial (TARGET) 2025 guideline, a consensus-based guidance for reporting observational studie...

In adaptive clinical trials, the conventional confidence interval (CI) for a treatment effect is prone to undesirable properties such as undercoverage and potential inconsistency with the final hypot...

Regulatory guidance notes the need for caution in the interpretation of confidence intervals (CIs) constructed during and after an adaptive clinical trial. Conventional CIs of the treatment effects a...

Regulatory guidance notes the need for caution in the interpretation of confidence intervals (CIs) constructed during and after an adaptive clinical trial. Conventional CIs of the treatment effects a...

In adaptive clinical trials, the conventional confidence interval (CI) for a treatment effect is prone to undesirable properties such as undercoverage and potential inconsistency with the final hypot...

Ask not for whom the bell tolls, it tolls for mRNA vaccines

Adaptive and platform trials (APTs) can be very efficient in addressing research questions in many ways, when implemented appropriately and robustly. Developing and implementing statistical analysis p...

ABSTRACT. Platform trials are an efficient way of testing multiple treatments. We consider platform trials where, if a treatment is found to be superior to

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A new twice-yearly shot could be a "game changer" in the fight against AIDS, but experts' hopes have dimmed because of the current political climate.

Background Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. However, there is overwhelming evidence that the...