About the event:

The Centre for Trials Research at Cardiff University is the largest group of academic clinical trials staff in Wales. We tackle the big diseases and health concerns of our time, including growing resistance to antibiotics, early cancer diagnosis and how to eliminate health inequalities. We achieve this by forming strategic partnerships with researchers, both seasoned and new, and building lasting relationships with the public, whose participation is essential for the success of our studies. The Centre for Trials Research is a UK Clinical Research Collaboration (UKCRC) registered clinical trials unit. The Centre is home to researchers, trial managers, computer systems experts, data managers, administrators, quality assurance managers and statisticians.
https://www.cardiff.ac.uk/centre-for-trials-research

This event, hosted by the RSS South Wales Local Group, consists of four talks on a variety of subjects relevant to statisticians, conveying the breadth of different research undertaken within a clinical trials unit like the Centre for Trials Research. There will be an opportunity for networking between and following the talks, and light refreshments will be provided.

 
Speakers:

Dr Rebecca Playle
Title: Designing early phase studies for individual patient data (IPD) meta-analysis (MA)

Mandy Lau
Title: Psychometric testing for validating a cancer symptom recognition measure

Dr Charlotte Wilhelm-Benartzi
Title: Surrogate Biomarkers and Surrogacy in novel clinical trial designs

Professor Adrian Mander

Title: Master Protocols and Platform Trials in Type 1 Diabetes
I will be describing an IMI-funded initiative called INNODIA which is a large consortium involved in setting up a clinical network capable of running multiple trials within an observational cohort. Newly diagnosed people with type 1 diabetes are recruited into the INNODIA platform and either begin a 2-year follow-up natural history study or become a participant in the available trials. There are a standardised set of repeated measurements over the course of the natural history study and trials. The Master Protocol outlines the standardised elements of the sub-trials. Master protocols are increasingly used to combine several sub-trials into a single document and are efficient when they have been written but are a huge task to construct.

The first sub-trial is an adaptive dose-ranging trial trying to look for a treatment effect on a dose that is known to show a difference but also to find a minimally effective low dose. There are seven interim analyses used to predict which dose is the best candidate of the low dose using the repeated measures C-peptide data using a Bayesian model. The second sub-trial is more standard two-arm parallel-groups trial but with the addition of an interim analysis to decide on whether to stop the trial early for futility or consider introducing a combination therapy arm. Several benefits of using platform trials with natural history components will be described alongside the potential issues that need to be resolved to maximise the information in this non-standard platform trial.
 

(Abstracts available HERE ) 

Attendance is free and open to all, whether fellows of the RSS or not, but pre-registration is required.