The National Institute for Health Research Diagnostic Evidence Co-operative Leeds (NIHR DEC Leeds) will explore the design and conduct of clinical research including novel efficient trial designs and new approaches to health economics and health informatics to underpin efficient in vitro diagnostic (IVD) research.

There is close collaboration with a large Canadian methodology programme looking at the health economics of personalised medicine technologies. The products of this research will be available to all stakeholders and the strategic development of this programme will be influenced by our stakeholder group and NHS requirements.

Study/trials design

Theme leads: Walter Gregory and

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.

Health economics

Theme leads: Bethany Shinkins and Claire Hulme (Supported Peter Hall and Chris McCabe)

We have specialist expertise in economic evaluation, cost-effectiveness analysis and efficient research design during IVD development, in addition to a strong track record of applied health technology assessment within the NHS including medical devices, drugs and diagnostic tests. Their expertise encompasses economic evaluation alongside clinical trials, model-based economic evaluation, Bayesian decision analysis, evidence synthesis, care pathway analysis and budget impact analysis.

Health informatics

Theme leads: Geoff Hall, Susan Clamp and Owen Johnson

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.