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Generating robust evidence for implementing diagnostic tests

Introducing new IVDs, such as biosensors, into widespread NHS practice is not easy and this is  partly because evidence generation has not been given full consideration at an early enough stage. For the NHS to buy and use new IVD tests, high quality diagnostic evidence is vital. This does not always mean an expensive randomised trial, but good alternatives have not always been evident to IVD developers. Sound health economics are also crucial as is the impact of that IVD test to the NHS organisation. 
One of the central points to recognise at the onset of the innovation process is the number of stakeholders with an interest and investment in the adoption of new technologies. Identifying unmet testing needs in healthcare should be an important driver of innovation, with the expectation that a new diagnostic technology that fulfils a current ‘gap’ is  more likely to be adopted. However different stockholders may perceive different needs. Conducting a stakeholder analysis early on can be hugely beneficial to the development process. 
Novel diagnostics, with the potential to disrupt current care pathways, are the most complex. Adopting the new technology, may result in changes to the patient care or outcome, which should be evaluated before widespread implementation. None of these issues have been simple for IVD developers to address on their own and for this reason the National Institute of Health has launched four centres of expertise called Diagnostic Evidence Co-operatives, located in London, Oxford, Leeds and Newcastle. These centres have the expertise to support both NICE and IVD developers in generating the right evidence, which should enable better uptake of new IVDs by the NHS (Diagnostics Forum 2013 Report).
The NIHR Diagnostic Evidence Co-operative London is based at Imperial College, St Mary’s Hospital Campus, the overall aim of the Centre is to develop world-class methods for Point of Care (POC) diagnostic test validation and facilitate efficient integration of these technologies into clinical practice. Their established clinical themes include gut health, primary and general care, respiratory disease, infectious disease, metabolic medicine, cardiovascular disease, cancer, women’s health and emergency medicine. As the needs and dimensions for evidence generation will differ with various devices, tests and environments, the centre has a flexible model for collaborative work. The dimensions for evidence generation include clinical assessment (validity, utility, care pathway and patient reported outcomes), economic analysis, design evaluation and barriers to implementation.
Their strategic partners include academic centres conducting state-of-the art research, engineers with integrated design tools, BIVDA for industrial support, and regulators to establish that the device can satisfy national and international standards. As well as facilitating high-quality evidence generation towards faster implementation and acceptance, the centre will establish a strong engagement strategy between the IVD industry, clinicians, academics, NHS commissioners, regulatory organisations and patient associations. If you require any information, please contact the Business Manager, Julie Hart: or visit
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