- Posted By: Susan Dutton
Professor John Matthews gave an interesting talk about the bias introduced to binary outcomes in randomised controlled trials due to omitted covariates (both known and unknown). The rest of the meeting was taken up with updates and discussion.
The Development of Statistical Analysis Plans (SAP) has been funded by a Methodological grant and will be taken forward over the next few months with the aim of providing guidelines for SAPs, similar to the SPIRIT guidelines for protocols.
A project on Trial Steering Committees (TSC) has also been funded with a methodological grant. An update on the first two sections of this was provided: the Review of Current Practices and Opinions of Trial Steering Committees; and a Review of a Cohort of Published Literature for Reporting of the Remits and Functions of TSCs was provided. The aim of this project is to provide guidelines and a charter as per Damocles for Data Monitoring Committees (DMC).
A discussion around providing a database of expert statisticians who will be able to be approached to be independent statisticians on either a DMC or a TSC was also discussed with particular emphasis on the definition of expert and what searchable features would be required. Also discussed was how to enable the development of new statisticians to become experts in order to widen the existing limited pool of experienced experts. This will potentially be undertaken by allowing shadowing of the experienced experts as they sit on TSCs and/or DMCs.