Advances in experimental medicine increasingly rely on the development of diagnostic devices, novel biomarkers, repurposing of existing tests, and identifying powerful test combinations.
The Diagnostics and Biomarkers cross-cutting theme is led by Professor Jon Deeks, and is building on the internationally influential programme of test evaluation research that Professor Deeks and the TERG team (Test Evaluation Research Group) have developed at Birmingham, combined with the resources of the early clinical trials facility D3B (Devices, Drugs, Diagnostics and Biomarkers) and the established Birmingham Clinical Trials Unit with capacity for late phase test evaluation.
The Diagnostics and Biomarkers theme works with the three key research themes in the NIHR Biomedical Research Centre to develop, design and deliver portfolios of test research studies, and to advance the methodology behind early evaluative studies.
The over-arching objective is to ensure that tests and biomarkers developed or used in the research themes undergo appropriate evaluation and assessment before being utilised as clinical tests or outcome measures, as well as improving the methodological basis upon which such assessments are made.
- Identify the measurements and biomarkers within the research themes and prioritise key markers for evaluation
- Complete rapid reviews of the statistical properties of key markers, and design studies to fully assess their variability and measurement properties
- Establish a methods training programme for researchers and trialists in the BRC
- Identify and develop methods, and publish guidance on the design and analysis of studies of biological variability
- Identify tests and biomarkers within the research themes requiring evaluation in patient pathways suitable for early evaluation by simulation
- Identify data required to develop simulation models of the patient pathways and evaluate the potential impact of introducing new tests and biomarkers
- Identify common formats for simulation models and develop software tools to enable efficient simulation studies to be completed
- Identify tests and biomarkers requiring further evaluation in later phase studies, and plan portfolios of studies and develop study protocols to take the experimental discovery findings through to evaluation in definitive trials
- Develop and publish frameworks to identify studies required to show that a test is fit for purpose.