About the project

Background and rationale:

In vitro diagnostics (IVDs) are tests that can detect disease, conditions, and infections; IVD results are central to 70% of all clinical and treatment decisions. IVDs have the potential to accelerate patient pathways, reduce hospital stays, facilitate targeted treatment schedules, and support patients to maintain their own health. Rapid expansion of testing technologies, data and deep learning solutions offer the opportunity to progress precision medicine and optimise the use of IVDs for patient and health care benefits. The adoption of IVDs within clinical pathways is slow and creates a barrier to innovation within health care. A key cause of this is a disjointed approach that fails to integrate academic, clinical and industry expertise from the outset. There is also a failure to exploit data to identify where diagnostic innovation could yield the greatest impact. As a result, IVDs are rarely designed for a specific pathway and many diagnostics are developed that have no clear plan to adoption. To address this, we need a new model that clearly identifies the role of IVDs in patient care and matches the development of IVDs to meet the needs of end-users. The PhD scholar will help to shape and trial this new approach in practice.

Objective 

To develop a new model for the development of IVDs that will enable their accelerated implementation into clinical practice to deliver patient and health care impact.

Aims

• Investigate how data can be used to help map care pathways and understand where a diagnostic test could potentially transform or improve a clinical pathway.
• Determine required properties of a diagnostic test to meet the pathway/need.
• Develop a worked solution in the laboratory, choosing an appropriate technology for the pathway, taking into consideration cost, time, and staff resource.
• For the identified solution, generate proof of concept and feasibility data.

Research Plan

1. Investigating the use of data to identify care pathways and the feasibility of using data to test if a new or alternative diagnostic is likely to have value within a pathway. This will tap into existing data initiatives geared towards revealing unmet needs for innovation. The main output will be the identification of a pathway/s that could be improved through a new or repurposed IVDs.
2. Engage with the NHS and patients to explore the identified pathways further and help ratify where and how a diagnostic test could improve a clinical pathway. Investigate the current testing rationale and establish the required specifications a diagnostic would need to fulfil to enable its adoption.
3. Design a target product profile for a new or repurposed diagnostic. The diagnostic solution will be matched to the meet the bespoke need and pathway identified in phases 1 & 2, selecting the most appropriate technology platform. Initial proof of concept for the test will be generated in the laboratory.

Impact

The project will act as a template and applied to the future scoping and development of a broad range of novel IVDs and medical technologies. This will provide an evidence base to enable a step-change in the use of diagnostic technologies in patient pathways within Birmingham Health Partners supported infrastructure.

Host environment

The project will be based within the Clinical Immunology Service (CIS) at the University of Birmingham Medical School. The CIS is an interface between laboratory, industry and clinical practice and has significant IVD development expertise. Training will include interdisciplinary skills in the context of the IVD translational pathway, learning how to engage/work with key stakeholders with dedicated placements. It provides an ideal environment to conduct this novel research but also provide bespoke training to place the PhD scholar on the trajectory to become a future leader in translational research that can deliver real-world impact.

References

1. Sensitive Detection of SARS-CoV-2-Specific Antibodies in Dried Blood Spot Samples. Morley GL, Taylor S, Jossi S, Perez-Toledo M, Faustini SE, Marcial-Juarez E, Shields AM, Goodall M, Allen JD, Watanabe Y, Newby ML, Crispin M, Drayson MT, Cunningham AF, Richter AG, O'Shea MK. (2020). Emerg Infect Dis, 26(12).
2. How to establish an academic SARS-CoV-2 testing laboratory. Richter A, Plant T, Kidd M, Bosworth A, Mayhew M, Megram O, Ashworth F, Crawford L, White T, Moles-Garcia E, Mirza J, Percival B, McNally A. (2020). Nat Microbiol, 5(12):1452-1454
3. Development of a high-sensitivity ELISA detecting IgG, IgA and IgM antibodies to the SARS-CoV-2 spike glycoprotein in serum and saliva. Faustini S, Jossi S, Perez-Toledo M, Shields A, Allen J, Watanabe Y, Newby M, Cook A, Willcox R, Salim M, Goodall M, Heaney JLJ, Marcial-Juarez E, Morley G. et al. (2021). Immunology, 164 (1), 135-147.
4. Development of a rapid and quantitative lateral flow assay for the simultaneous measurement of serum κ and λ immunoglobulin free light chains (FLC): inception of a new near-patient FLC screening tool. Campbell JP, Heaney JL, Shemar M, Baldwin D, Griffin AE, Oldridge E, Goodall M, Afzal Z, Plant T, Cobbold M, Jefferis R, Jacobs JF, Hand C, Drayson MT. (2017). Clinical Chemistry and Laboratory Medicine, 55 (3), 424-434.
5. Mapping inpatient care pathways for patients with COPD: an observational study using routinely collected electronic hospital record data. Evison F, Cooper R, Gallier S, Missier P, Sayer AA, Sapey E, Witham MD. (2023). ERJ Open Res, 9(5):00110-2023.
6. Variability and performance of NHS England's 'reason to reside' criteria in predicting hospital discharge in acute hospitals in England: a retrospective, observational cohort study. Sapey E, Gallier S, Evison F, McNulty D, Reeves K, Ball S. (2022). BMJ Open, 12(12):e065862.

Entry Requirements

Applicants should have a strong background in biological or medical sciences. They should have an interest in improving clinical pathways for patients through diagnostics and data as enabling technology.

Applicants will be expected to have a good Honours degree (First Class or Upper Second Class Honours degree) awarded by a recognised University in biological or medical sciences or other discipline relevant to the PhD project e.g. bioinformatics, medical sciences, biomedical technology. Study at MSc level in one of these fields is desirable but not essential. 

What does the scholarship provide?

1. Financial Support: Recipients of these scholarships will receive substantial financial support, including a stipend at UKRI rates, which is set at £18,622 per year. This support covers tuition fees, living expenses, and research-related costs, including bench fees. This support is designed to alleviate the financial burden often associated with pursuing a doctoral degree.
2. Mentorship and Guidance: Scholarship recipients will benefit from mentorship opportunities and guidance from accomplished faculty members who are dedicated to helping them succeed in their academic and research endeavours.
3. Research Opportunities: We are committed to providing an exceptional research environment. Students will have access to state-of-the-art facilities, cutting-edge resources, and a vibrant scholarly community.
4. Community Building: A key component of the scholarship programme is the creation of a supportive community of Black British researchers pursuing PhDs. This network will foster collaboration and peer support among scholars.
5. Research Training Support Grant: In addition to financial support, scholarship recipients will receive a research training support grant. This grant is intended to support conference attendance, fieldwork, and other essential activities that enhance their research and academic growth.
6. Commitment to Inclusivity: We are dedicated to building an inclusive academic environment that values diversity and ensures equitable access to education.

Contact the lead supervisor

Once applicants have familiarised themselves with the above project details, they are encouraged to contact the lead PhD supervisor to discuss the project and the applicant's suitability for the project. This is recommended before you submit an application to the PhD project.

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