Title: NIHR Leeds In Vitro Diagnostics Co-operative (short name: NIHR Leeds IVD Co-operative)
Funder: Department of Health and Social Care

Abstract: The NIHR MIC-DEL will build on the success of the Leeds NIHR Diagnostic Evidence Co-operative (DEC) which has submitted joint applications with 88 companies with 60% success rate, leveraged >&pound;34M, and has 57 active and 20 completed projects since established in 2013. Our aim will be to accelerate the development and clinical deployment of commercial in vitro diagnostics in cancer, musculoskeletal disease, renal medicine and infection diagnostics, all areas with significant clinical needs for improved diagnostics in primary and secondary care settings (see section 10). Each clinical theme will have access to expertise in health economics, clinical trials, informatics and multi-disciplinary pathology, all essential components for the development of IVD s and for which many smaller companies will not have in-house teams. The structure of our MIC is based on feedback from industry partners. Access to health economics is key. We assess the potential value to the NHS of a diagnostic at an early stage in development to ensure that only projects are progressed, which will save the NHS money and bring benefit to patients. This has a beneficial impact on resource utilisation for developers and creates confidence. The Test Evaluation Group within the Academic Unit of Health Economics at UoL is recognised nationally and internationally as leaders in this approach and over the next 5 years they will look at developing new and improved methods for such analyses. Our informatics capabilities bring digitally integrated health data for 3 million people in Leeds, providing a rich research database of real world evidence of clinical practice and data on a greater scale than any other part of the English NHS. Informatics will support the development of IVDs through a detailed analysis of current practice and examining the real benefits on real people through the real data collected and managed through the Regions informatics systems. There will be close alignment between informaticians and the health economics team. Well designed and robust clinical trials for IVDs in primary and secondary care settings are essential for their validation and evaluation. Evaluation and clinical trial design can be complex since clinical outcomes (and effectiveness) may be affected by a combination of factors including test accuracy, test availability, associated decision making (including timing and confidence in test accuracy), resulting treatment decisions and the effectiveness of those treatments We give details of substantial investments in our work from University, NHS and LTHT Charitable Foundation which together with NIHR MIC funding will allow us to sustain the previous success of the DEC, grow our portfolio of commercial partnerships and projects by 25% per year for 2 years, contribute to UK economic growth, improve methods for research in clinical trials, health economics and health information science, involve our patients in our research planning and in its delivery and generate a financially robust IVD research partnership with commercial IVD developers and manufacturers.

Lay abstract: The NIHR MIC-DEL will build on the success of the Leeds NIHR Diagnostic Evidence Co-operative (DEC) which has submitted joint applications with 88 companies with 60% success rate, leveraged >&pound;34M, and has 57 active and 20 completed projects since established in 2013. Our aim will be to accelerate the development and clinical deployment of commercial in vitro diagnostics in cancer, musculoskeletal disease, renal medicine and infection diagnostics, all areas with significant clinical needs for improved diagnostics in primary and secondary care settings (see section 10). Each clinical theme will have access to expertise in health economics, clinical trials, informatics and multi-disciplinary pathology, all essential components for the development of IVD s and for which many smaller companies will not have in-house teams. The structure of our MIC is based on feedback from industry partners. Access to health economics is key. We assess the potential value to the NHS of a diagnostic at an early stage in development to ensure that only projects are progressed, which will save the NHS money and bring benefit to patients. This has a beneficial impact on resource utilisation for developers and creates confidence. The Test Evaluation Group within the Academic Unit of Health Economics at UoL is recognised nationally and internationally as leaders in this approach and over the next 5 years they will look at developing new and improved methods for such analyses. Our informatics capabilities bring digitally integrated health data for 3 million people in Leeds, providing a rich research database of real world evidence of clinical practice and data on a greater scale than any other part of the English NHS. Informatics will support the development of IVDs through a detailed analysis of current practice and examining the real benefits on real people through the real data collected and managed through the Regions informatics systems. There will be close alignment between informaticians and the health economics team. Well designed and robust clinical trials for IVDs in primary and secondary care settings are essential for their validation and evaluation. Evaluation and clinical trial design can be complex since clinical outcomes (and effectiveness) may be affected by a combination of factors including test accuracy, test availability, associated decision making (including timing and confidence in test accuracy), resulting treatment decisions and the effectiveness of those treatments We give details of substantial investments in our work from University, NHS and LTHT Charitable Foundation which together with NIHR MIC funding will allow us to sustain the previous success of the DEC, grow our portfolio of commercial partnerships and projects by 25% per year for 2 years, contribute to UK economic growth, improve methods for research in clinical trials, health economics and health information science, involve our patients in our research planning and in its delivery and generate a financially robust IVD research partnership with commercial IVD developers and manufacturers.

Research activity codes: 4.5 RESOURCES AND INFRASTRUCTURE (DETECTION);8.5 RESOURCES AND INFRASTRUCTURE (HEALTH SERVICES)
Health categories: CANCER AND NEOPLASMS;INFECTION;RENAL AND UROGENITAL