This course is aimed at those currently or soon to be involved in Independent Data Monitoring Committees (IDMC), and will answer the question: "What do people who serve on them, report to them or receive reports from them need to know?”

Our aim in this course is to provide participants with the ability to analyse their own data using multiple imputation, but also to be aware of the pitfalls and limitations of the technique.

This course builds on a basic course in sample-size calculations such as the one provided by the ICH, and provides an overview of the underlying statistical theory for sample size calculations within the hypothesis testing framework. It addresses practical issues and statistical considerations when calculating sample sizes for a wide range of advanced trial designs and outcome distributions, including factorial, non-inferiority, DURATIONS, group sequential, and clustered randomised clinical trials. It uses real advanced trial examples to calculate the sample size using the available user-written software in both R and Stata. 

Those working on trials and study designs, which includes trialists, trial statisticians, clinicians and other scientists. Familiarity with the hypothesis testing framework (i.e., type I error rate, power, and various effect sizes) are essential. Familiarity with sample size calculation for simple/basic designs is desirable but not essential.

This face-to-face course is covering how to conduct a Platform trial from set-up to reporting, particularly focussing on the aspects that are different or more difficult compared to a more typical two arm randomised controlled trial.

The course is a mixture of didactic sessions and activity-based sessions and is targeted towards trial managers, data managers and those writing databases, particularly those with experience of typical two arm randomised controlled trials. It would also be useful for Chief investigators and statisticians interested in the operational aspects of conducting a platform trial.

This course is a practical, interactive workshop for those working in clinical trials who wish to or who already actively involve patients or the public in their trials. It offers participants the opportunity to:

• build an understanding of PPI in health research and specifically in clinical trials;
• begin involving patients and public in their research, and/or develop their involvement activities in a meaningful manner; and learn from other participants about what works in specific contexts.