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  Innovative designs for diagnostic test evaluation trials

   Population Health Sciences Institute

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  Prof J Wason, Dr Will Jones, Dr Clare Lendrem, Dr Faye Williamson, Dr Kevin Wilson  No more applications being accepted  Competition Funded PhD Project (Students Worldwide)

About the Project

Background to the project. A diagnostic test is used to help diagnose a disease or condition. For a new diagnostic test to be adopted into a healthcare system, such as the NHS, it must undergo a series of scientific studies, including randomised controlled trials (RCTs), to demonstrate its safety, performance/accuracy, and cost effectiveness. Currently, it can take more than 10 years and considerable resources to generate this evidence, since these studies are typically conducted sequentially with long time gaps (sometimes years) in between.

This prolonged evidence generation process means patients may wait a long time for novel diagnostics and developers may struggle to stay in business for the full duration. Large companies have the resources to develop new diagnostics, but can lack the incentive to do so, given the significant delay in the return of investment. Innovative trial designs have enormous potential to help but have not been thoroughly considered for trials of diagnostic tests.

What the studentship will encompass: The PhD candidate will explore how the evidence generation process can be streamlined using Bayesian, adaptive, and seamless clinical trial designs. These approaches offer flexibility, improved efficiency, and better outcomes for trial participants.

Although adaptive and seamless designs are reasonably well established in interventional studies, they have received little attention in diagnostics. However, the flexibility offered by these designs is just as important in diagnostic studies. The PhD candidate will identify and overcome methodological barriers to using these approaches in the diagnostic context, with a view to accelerating the evidence generation process. This has been highlighted as a promising area for future research (Zapf et al, 2020, doi:10.1002/sim.8430).

The project will involve: 1) performing a systematic literature review on innovative clinical trial designs, including differences in requirements for diagnostic test evaluation trials; 2) developing methodology to overcome identified barriers. It is envisioned that this methodology work will include: (i) extending existing work to tests giving continuous rather than binary responses; (ii) consideration of RCTs assessing long-term effectiveness of a test within a complex pathway, where the number of parameters influencing the power of the trial is higher and more complex (e.g. adaptive and Bayesian) methods are required; (iii) consideration of platform RCTs incorporating diagnostic accuracy studies and longer-term RCTs, where patients may be evaluated with a set of tests rather than just one. Importantly, the developed methods will be implemented in high-quality open-source software to enable their wider use.

The PhD candidate will be supervised by a multidisciplinary team:

·      Biostatistics Research Group: Prof James Wason, Professor of Biostatistics, and Dr Faye Williamson, Research Associate (Biostatistician), are experts in developing and implementing innovative trial designs.

·      School of Mathematics, Statistics & Physics: Kevin Wilson, Senior Lecturer in Statistics, specialises in methodological developments in Bayesian analysis and diagnostic test evaluation.

·      National Institute of Health Research (NIHR) Newcastle In Vitro Diagnostics Cooperative (Newcastle MIC): Will Jones and Clare Lendrem, Diagnostic Methodologists. The Newcastle MIC is an independent NIHR-funded group with a remit of developing methodology and helping diagnostic developers generate high quality evidence on their diagnostic tests. The Newcastle MIC has a constant stream of real-world diagnostic projects. This PhD candidate will partly sit within this group and will have opportunities to leverage data from live diagnostic projects.

The candidate will have the opportunity to discuss their research with Newcastle MIC PPIE groups.

Candidates should have appropriate undergraduate and/or Masters degree qualifications in a quantitative subject such as mathematics or statistics.


You are applying for a PhD studentship from the MRC TMRP DTP. A list of potential projects and the application form is available online at:

Please complete the form fully. Incomplete forms will not be considered. CVs will not be accepted for this scheme.

Please apply giving details for your first choice project. You can provide details of up to two other TMRP DTP projects you may be interested in at section B of the application form.

Before making an application, applicants should contact the project primary supervisor to find out more about the project and to discuss their interests in the research.

The deadline for applications is 4pm (GMT) 18 February 2022. Late applications will not be considered.

Completed application forms must be returned to: [Email Address Removed]

Informal enquiries may be made to [Email Address Removed]

Mathematics (25) Medicine (26)

Funding Notes

Studentships are funded by the Medical Research Council (MRC) for 3 years. Funding will cover tuition fees at the UK rate only, a Research Training and Support Grant (RTSG) and stipend (stipend to include London Weighting where appropriate). We aim to support the most outstanding applicants from outside the UK and are able to offer a limited number of bursaries that will enable full studentships to be awarded to international applicants. These full studentships will only be awarded to exceptional quality candidates, due to the competitive nature of this scheme.
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