Title: NCITA: National Cancer Imaging Translational Accelerator
Funder: Cancer Research UK

Abstract: Background: Many imaging biomarkers (IBs) have the potential to alter clinical practice, but at present almost all have incomplete validation. Successful IB development necessitates an interdisciplinary collaborative approach aimed at affirming biological, technical, clinical and health economic validity; pre-requisites for IB adoption by pharmaceutical companies and adoption within the National Health Service (NHS). The infrastructure required for effectively delivering 'an IB product' is scarce, and where present it has been established in an ad-hoc piecemeal fashion, often with duplication across sites, without effective cross-site coordination and has focused on dealing with problems identified by the local investigator. To date, infrastructure support to address translational gaps has not been recognised as a priority for academic institutions, funding bodies, pharmaceutical companies or the NHS - stifling clinical adoption of IBs. Aims: The National Cancer Imaging Translational Accelerator (NCITA) aims to establish a fast and robust cross-institutional pipeline to produce quality assured locked down Imaging Biomarkers (IB): both for drug discovery within pharma clinical trials leading to more efficient development of cancer therapies; and practice changing paradigms within the NHS for areas of unmet clinical need. Methods: This National Cancer Imaging Translational Accelerator (NCITA) proposal aims to establish the much-needed infrastructure to bridge the translational gap, enabling co-ordination between complementary local structures and providing a unified mechanism for 'route to market' for IBs - in essence provisioning the translational pipeline as proposed in the 'Imaging Biomarker Roadmap' initiated, sponsored and endorsed by CRUK [O'Connor et al, Nature Reviews Clinical Oncology (2017)]). NCITA will establish three cross-institutional (Cambridge, Imperial, ICR, KCL, Manchester, Oxford, and UCL) synergistic units - QA/QC Unit, Imaging Trials Unit and Repository Unit capable of supporting design, recruitment, core lab analysis, data sharing with locked-down processing necessary to and produce 'certified' IBs. NCITA will continue the Cancer Imaging Centres initiative of training the next generation of imaging scientists (extending this this to NCITA unit staff), produce a unified contract between institutions to reduce start-up time for studies, and work with IB consumers (NHS, pharma) and imaging equipment manufacturers to design a robust certification process needed to instill reliability and confidence in the application of IBs as decision making tools. How the results will be used: IB studies will be accelerated to delivery through adoption into the infrastructure. Certification will lead to a greater adoption into clinical practice of IBs. The collaborative approach will reduce costs of development.

Lay abstract: Background: Many imaging biomarkers (IBs) have the potential to alter clinical practice, but at present almost all have incomplete validation. Successful IB development necessitates an interdisciplinary collaborative approach aimed at affirming biological, technical, clinical and health economic validity; pre-requisites for IB adoption by pharmaceutical companies and adoption within the National Health Service (NHS). The infrastructure required for effectively delivering 'an IB product' is scarce, and where present it has been established in an ad-hoc piecemeal fashion, often with duplication across sites, without effective cross-site coordination and has focused on dealing with problems identified by the local investigator. To date, infrastructure support to address translational gaps has not been recognised as a priority for academic institutions, funding bodies, pharmaceutical companies or the NHS - stifling clinical adoption of IBs. Aims: The National Cancer Imaging Translational Accelerator (NCITA) aims to establish a fast and robust cross-institutional pipeline to produce quality assured locked down Imaging Biomarkers (IB): both for drug discovery within pharma clinical trials leading to more efficient development of cancer therapies; and practice changing paradigms within the NHS for areas of unmet clinical need. Methods: This National Cancer Imaging Translational Accelerator (NCITA) proposal aims to establish the much-needed infrastructure to bridge the translational gap, enabling co-ordination between complementary local structures and providing a unified mechanism for 'route to market' for IBs - in essence provisioning the translational pipeline as proposed in the 'Imaging Biomarker Roadmap' initiated, sponsored and endorsed by CRUK [O'Connor et al, Nature Reviews Clinical Oncology (2017)]). NCITA will establish three cross-institutional (Cambridge, Imperial, ICR, KCL, Manchester, Oxford, and UCL) synergistic units - QA/QC Unit, Imaging Trials Unit and Repository Unit capable of supporting design, recruitment, core lab analysis, data sharing with locked-down processing necessary to and produce 'certified' IBs. NCITA will continue the Cancer Imaging Centres initiative of training the next generation of imaging scientists (extending this this to NCITA unit staff), produce a unified contract between institutions to reduce start-up time for studies, and work with IB consumers (NHS, pharma) and imaging equipment manufacturers to design a robust certification process needed to instill reliability and confidence in the application of IBs as decision making tools. How the results will be used: IB studies will be accelerated to delivery through adoption into the infrastructure. Certification will lead to a greater adoption into clinical practice of IBs. The collaborative approach will reduce costs of development.

Research activity codes: 4.5 RESOURCES AND INFRASTRUCTURE (DETECTION)
Health categories: CANCER AND NEOPLASMS