At the NIHR Leeds In Vitro Diagnostics Co-operative there are four cross-cutting themes which support the IVD evaluation pathway which include:

Health economics

Theme lead: Dr Bethany Shinkins

Demonstrating both the clinical- and cost-effectiveness of an IVD is pivotal to NHS adoption. We aim to assess the potential value to the NHS of a diagnostic at an early stage, to ensure that only those that demonstrate sufficient patient benefits are progressed.

We have built a strong collaborative relationship with the Test Evaluation Group, in the Academic Unit of Health Economics at the University of Leeds to produce high quality health economic evaluations of commercialised IVDs.

In addition to our extensive portfolio of completed collaborative projects through the NIHR Leeds DEC, we are now also working hard to develop methodologies to overcome some of the issues around the economic evaluation of tests.

Health informatics

Theme leads: Geoff Hall

The Yorkshire Centre for Health Informatics (YCHI) has developed strong relationships with industrial partners, including several Technology Strategy Board grants. These focus on data-mining of clinical pathways and electronic records to produce risk models and identify clinical need and impact.

In addition, the National Laboratory Medicine Catalogue (NLMC), the diagnostic equivalent of the British National Formulary, has been developed within YCHI. This is ready for use and its adoption will standardise data flows for all NHS diagnostics. We have set up a Clinical Decision Algorithms Unit based on antenatal risk assessment software with expertise in CE marking and quality assurance and a growing list of internal and external clients.

Clinical Trials (Leeds Clinical Trials Research Unit)

Theme lead: Jane Nixon

We have expertise in research design and statistical modelling for the validation and development of biomarker-associated interventions. Within the methodology group there is a track record of method development in adaptive trial design. Members have experience in the design and conduct of pragmatic randomised controlled trials (RCTs) in NHS settings.

We are particularly interested in developing approaches which bring together statistical and economic modelling with “short and cheap” RCTs of the process of care with some “long, expensive end-to-end” RCTs to find a realistic design portfolio that may be deliverable within time and cost constraints.

Multidisciplinary Pathology

Theme lead: Philip Quirke

We are developing a world-class integrated academic pathology network, with expertise in Oncological Haematology, Histopathology,Digital and Molecular Pathology.

This will enable us to conduct rigorous analytical evaluation and validation of innovative IVDs and support IVD manufacturers to enable them to meet the Performance Evaluation requirements of the new IVD regulations.

We will collaborate internationally with relevant organisations to develop robust methodology and recommendations to support validation of IVDs.

Through a growing network, we will help develop the next generation of academic pathology leadership and promote best practice between pathology disciplines.