UKCRC Statisticians Operational Group Meeting 02Oct2017


The bi-annual Statisticians’ Operational Group meeting took place at the University of Manchester. Susan Dutton and Sharon Love attended on behalf of OCTRU.

Following a welcome and overview of the Manchester Academic Health Science Centre Clinical Trials Unit, Richard Emsley and Graham Dunn gave presentations about “Causal Modelling in Trials”. These included a session on complier average causal effect or CACE analysis, which investigates the effect of compliance with the intervention on the outcome, and a session on Mediation analysis, which can be useful in investigating the underlying mechanism of action. Many of the trials being undertaken in OCTRU are starting to introduce CACE analysis as supporting analyses and it is important that the Statisticians understand the underlying methods. As a result of this, we have invited Richard and Graham to Oxford to give a workshop on Causal Inference in Clinical Trials and will encourage the statisticians working on trials in OCTRU and CSM to attend the workshop.

The members then broke out into groups to discuss statistical good practice, particularly in relation to randomisation, statistical programming and analysis. This followed a survey to all the CTUs and is part of an ongoing Stats Validation Plan Project led by the Core Steering Committee.

An update on the Good Statistical Practice Project was then presented by Deborah Stocken. This project aims to provide specific training on statistical aspects of GCP, as the current GCP training is thought to be too generic. A survey has been undertaken to identify what needs to be included in the training slides, and these are now being developed. The first units will be piloted for the training in November and OCTRU have offered to be part of the second phase of pilot units which will likely take place early in the new year.

The guidelines for statistical analysis plan that has been ongoing for a number of years has been accepted for publication and should be available soon.
The next meeting will take place in April 2018.