Development Pathway

Development

Further refinement of the product is carried out, as well as evidence gathering for any regulations that will apply. Clinical effectiveness and business case data should also be considered at this stage.

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The NIHR CLAHRCs develop robust evidence of the effectiveness and efficiency of these services and facilitates rapid implementation of evidence-based changes for the benefit of patients. The NIHR CLAHRC Oxford works closely with the users of research, including clinicians, patients, commissioners, and the public and provides funding and support for innovative research into new ways of providing and targeting services; patient self-management; and integrated care across organisational boundaries

Relevance:Devices and DiagnosticsDigital

The NIHR Diagnostic Evidence Co-operatives are at the forefront of evaluating and testing diagnostics. The NIHR DEC Oxford has emerged from expertise in primary care and diagnostic research, and provides core resources to establish the group as a UK resource in identifying, evaluating, and implementing in vitro diagnostic tests in primary care. The team brings expertise in all aspects of diagnostic test research including diagnostic accuracy studies, diagnostic test evaluation, systematic reviews, needs assessment surveys, qualitative studies, statistics and health economics studies

Relevance:Devices and Diagnostics

Established by the University of Oxford in 1996, Health Economics Research Centre aim is to contribute to health and healthcare in the UK and internationally, by conducting research on economic aspects of health and disease, the costs and benefits of prevention and treatment, and the design and evaluation of health systems. Economic evaluation forms much of HERC’s work and its methods can be applied in many contexts to assess the cost-effectiveness of treatments, procedures, diagnostic methods, screening practices, healthcare delivery routes and new technologies. Researchers carry out economic analysis alongside clinical trials using data from the trial and carry out modelling studies using data from trials and other sources

Relevance:PharmaceuticalDevices and DiagnosticsDigital

The Joint Research Office combining University and NHS staff provides timely and professional administrative support for industry. The experienced contractual support team has a track record of working with a wide range of external bodies. The JRO can also provide access to specialist teams of statisticians and health economists, skilled in the assessment of study data to determine the feasibility of interventions. Dedicated business development staff streamlines the collaborative procedure from conception to completion.

Relevance:PharmaceuticalDevices and DiagnosticsDigital

The early access to medicines scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need

Relevance:Pharmaceutical

Directive 98/79/ECof the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

Relevance:Devices and Diagnostics
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