Our world-leading statisticians have contributed to the UK Mini Mitral Trial research into the repair of one of the heart’s valves during surgery.
The experts from our Mathematical Sciences department were part of the design process, where the most important outcomes of the study that determine its design and size were chosen. This is referred to as the primary outcome.
They also justified that 330 participants for the study were sufficient to detect any important differences between the two treatment groups being compared.
This is crucial because the sample size must neither be too small (which would render the results unreliable) nor too large (which would unnecessarily expose participants to potential risks associated with the study).
Our statisticians also developed the Statistical Analysis Plan (SAP). This document is highly important in the analysis of clinical trial data as it promotes transparency, consistency and reproducibility.
It helps minimise bias, ensures compliance with regulatory authorities, and aids data monitoring and safety. Statisticians are also part of the project’s trial management group, and they contribute by looking at the safety data to ensure that the treatments are safe.
Our statisticians carried out the data analysis for the study.
They analysed the primary outcome using a statistical principle called Intention-to-Treat (ITT) analysis.
ITT analysis involves analysing participants based on their original assigned treatment groups, regardless of whether they completed the treatment or dropped out of the trial.
The rationale behind this is to reflect real-life scenarios more accurately, as adherence to treatment plans and study completion is not perfect in practice.
Additionally, our statisticians generated tables, listings and figures to help the clinical team in understanding the data.
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