Advancing immunotherapy treatment of type I diabetes across the globe through innovative and adaptive platform trials - China Scholarship Council Project

In 2015 the Innovative Medicines Initiative funded INNODIA consortium, a phase 2 platform trial in people newly diagnosed with type 1 diabetes, with many European partners. Unlike most platform trials, INNODIA has a natural history (or observational) cohort of participants alongside several randomised placebo-controlled trials. A master protocol (MP), which has received approval from the European Medicines Agency (EMA), has been developed for the platform and four sub-trials. The trials will start recruitment from September 2020 to test an array of immunotherapy administrations, each one entailing a different mix and duration of clinical contact that may make them more or less attractive to individuals. To reflect this, participants will be offered the opportunity to join either a trial or alternatively to be monitored as part of the existing natural history cohort.

The primary endpoint for most trials is the stimulated C-peptide response using a mixed meal tolerance test and other important endpoints include monthly measurements of C-peptide using dried blood spot technology, continuous glucose monitoring and other blood measurements. There is no consensus with regulators as to which primary endpoints should be used in type 1 diabetes. To address this the project will first investigate how to handle multiple outcome data simultaneously. This will include developing methods to control for multiplicity and error rate control. Additionally, we will explore the use prognostic and predictive `omics’ measurements or biomarkers to understand whether future trials should be enriched for specific subgroups most likely to benefit.

Platform trials are relatively new, yet their flexibility is attractive and timely. For these reasons they are increasingly being seen as the design of choice in Covid-SARS2 trials. Often, they are used in homogenous populations which makes the synthesis of data across the trials straightforward. However, in INNODIA the sub-trial populations are heterogenous due to differing age groups (from 7 to 45, the natural history study from 1 to 45) and types of interventions. This can make it challenging to collect a common shared control group across the sub-trials. Additionally, many of the other platform trials do not have a natural history cohort attached, and this presents an exciting opportunity to use this information to improve the design and analysis of the platform trial. We will investigate Bayesian methods, such as commensurate and predictive power priors; network meta-analysis, and causal inference procedures to synthesise the observational and trial components of the data (including instrumental variable methods). The hope is that these methods will help uncover effective treatments sooner, so that more patients can benefit.

We are looking for a motivated and hard working individual to join this global consortium. They will develop strong quantitative skills in statistics, data science and clinical trial design, as well as state-of-the-art knowledge of type 1diabetes and its effective treatment.

Entry Requirements

Applicants should possess or be predicted a minimum of an upper second class Honours degree, master's degree, or equivalent in a relevant subject. Applicants will be required to meet the minimum University English Language requirements (e.g. 6.5 IELTS)

How to Apply

This cycle of applications relates to start dates from October 2022. CSC applications should be made in accordance with CSC guidance. http://www.csc.edu.cn/

There are four steps to applying.

1. Apply to Cardiff University by Thursday 16th December to study for your chosen PhD:

Please apply to the school via the following link Medicine - Study - Cardiff University noting the additional requirements listed below. We advise you apply in advance of the deadline. You can submit your evidence of your English Language proficiency after the application deadline.

There is a box at the top right of the page labelled ‘Apply’, please ensure you select the correct ‘Qualification’ (Doctor of Philosophy), the correct ‘Mode of Study’ (Full Time) and the correct ‘Start Date’ (October 2022). This will take you to the application portal. 

In order to be considered candidates must submit the following information:  

• Qualification certificates 
• References x 2 
• Proof of English language (if applicable) 
• Attach an Academic CV. Further guidance can be found at http://www.vitae.ac.uk/researcher-careers/pursuing-an-academic-career/how-to-write-an-academic-cv
• Ensure the Personal Statement (part of the University application form) provides a clear explanation of the research interest, preparation undertaken, and an understanding of the significance of the research. Further guidance can be found at https://www.vitae.ac.uk/researcher-careers/pursuing-an-academic-career/writing-a-statement-of-academic-research-interest
• Select ‘No, I am not self-funding my research’ when prompted on the University application form.
• When asked ‘Please give the name of funding you are applying for’, enter the ‘Cardiff University China Scholarship Council

2. Your School will shortlist applicants to nominate to the University panel. Schools will need to make their nominations by 25 January 2022. To be nominated, you must have an offer of study, met the School selection criteria and met the English Language requirements.

3. If you are awarded a tuition fee only scholarship by the University panel, you will be issued with a tuition fee only scholarship letter. If you accept the offer, you then need to apply via the Cardiff University partnership portal. This will open around March.

4. Cardiff University will send a list of those who have accepted the tuition only scholarships to CSC, who match this with applications received via the CSC Cardiff University partnership portal. The CSC panel will award scholarships. The tuition fee only scholarship is only valid if you also receive the CSC scholarship.