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The HRC in In-vitro diagnostics supports innovators to accelerate their market adoption, evaluate and generate evidence, develop research methods, and support diagnostic test development. The centre has access to extensive clinical networks, academic collaborators and advanced assessment methodologies, uniquely positioned to support innovators, from individuals to small and medium-sized enterprises and large multinational organisations.
About HRC's theme
In-vitro ("in glass") diagnostics refers to the testing of samples (e.g. blood, urine, tissue) outside of the body (usually in petri dishes or test tubes) to detect or monitor diseases, or for screening. This HRC focuses on innovations for cancer, infectious and respiratory diseases, in a range of different settings from hospital to community.
Support provided
- Clinical translational research: supporting the rapid clinical evaluation of medical technologies through the design and delivery of robust clinical trials, providing access to patients and samples. The approach includes the development of biomarker-associated interventions and randomised controlled trials.
- Biomarker translation: the Biomarker Toolkit enables critical appraisal of biomarkers across four key categories: rationale, clinical validity, clinical utility, and analytical validity. By applying this toolkit, researchers can identify gaps in their studies, guide the development of biomarkers toward clinical implementation, and determine which candidates show the most promise for clinical use.
- Clinical pathways analysis: engage with key stakeholders and develop a thorough map of the current clinical pathway, bottlenecks, and opportunities for the integration of an innovation. From this we can identify scenarios of use and potential barriers to the adoption of the innovation.
- Decision analysis: studies focus on understanding the impact that a healthcare innovation could have on clinical decision-making practices, utilising a range of methods to analyse decision-making, to gain insight on the degree to which an innovation can support clinicians' decision-making and to identify clinical decision implications.
- Understanding barriers to adoption: insight into barriers to adoption or implementation can be used at different stages of the design cycle to enhance product design, development, and integration. Engage with key stakeholders within specific clinical pathways and develop a map of the clinical pathway, bottlenecks, and opportunities for the integration of an innovation, and identify scenarios of use and potential barriers to the adoption.
- Health economics and market analysis: evaluations focus on identifying the optimal placement for a new technology within existing care pathways and describe the health and cost effectiveness of introducing a new device.
- Patient and Public Involvement and Engagement (PPIE): support innovators looking to produce solutions for any care setting or pathway. Doing so recognises the value of bringing together people of all ages and backgrounds with experience of the health and care system. Patient and public engagement brings patients, service users, carers, and community members together from a range of groups to inform our studies.
- Cancer
- Infectious and respiratory diseases
- Critical care
- Primary and social care
- Methodology
- Real-world evidence generation
- Human factors evaluation
- Health Economics Evaluation
- Needs-focused, 360 degrees roadmapping
- Public and patient involvement and engagement (PPIE)
- Adoption
- Scaling up technology readiness
- Regulatory readiness support
- Human factors laboratory validation