Workplan

This work package aims to evaluate the accuracy of blood-based biomarkers provided by the leading biomarker companies in identifying liver fibrosis in healthy subjects. Using approximately 25,000 samples collected from previous studies of patients without liver disease, we will measure and analyse how well these biomarkers work to identify whether a patient has liver fibrosis as determined by liver stiffness measurements using ultrasound technology. A statistical analysis of the accuracy of serum biomarkers will be performed, the results of which will be used to develop the screening platform in WP3.

This work package led by the Fundació de Recerca Clínic Barcelona-Institut d’Investigacions Biomèdiques August Pi i Sunyer, and co-led by Siemens includes the following LIVERAIM partners: UAB, OUH, UNIPD, Roche, Sysmex, Nordic Bioscience.

WP2 aims to study the association of biomarkers and long-term outcomes. The overall goal is to develop a digital tool for use to calculate a personalized risk score.

This work package will combine retrospective long-term follow up data from patients who participated the LITMUS study (European MASLD registry), the GALA-ALD cohort and the Mayo Clinic MRI Study with prospective follow-up data from the long-term outcome in liver disease (LOVE) study. Over 2000 patients from across these study cohorts will be invited back for additional follow up. Samples obtained from these participants will be analysed using the biomarkers provided by the LIVERAIM industry partners. A comparative analysis will be performed to develop a digital personalized risk score tool.

This work package led by University Medical Centre Saarland, and co-led by Boehringer Ingelheim includes the following LIVERAIM partners: UNEW, UNITO; AP-HP, UMCU, OUH, FRCB-IDIBAPS, HCB, Mayo Clinic, ISGLOBAL, Roche, Nordic Bioscience, Sysmex, Siemens.

Artificial Intelligence (AI)-based techniques hold immense potential in predicting risk scores for chronic conditions like liver disease by integrating real-world data from patients and stratifying them according to risk levels. With such a platform, we hope to identify patients who would benefit most from early interventions (WP4). By leveraging diverse data sources including patient demographics, medical history, lifestyle factors, and biomarkers, AI algorithms can accurately assess individual risk profiles and identify those patients that could benefit from a therapeutic intervention. This proactive approach aims to improve patient outcomes and also optimize clinical resource allocation, leading to more efficient and effective management of chronic diseases like liver disease.

This work package will focus on how to integrate the biomarker panel and clinical data into a predictive tool for early diagnosis of liver fibrosis.

This work package led by the Barcelona Institute for Global Health, and co-led by Echosens includes the following LIVERAIM partners: FRCB-IDIBAPS, HCB, UAB, OUH, UNIPD, UNEW, ICAN, UNITO, Siemens, Roche, Sysmex, Nordic.

This ambitious WP will study the digital tool developed in WP 3 in the largest ever clinical study to be performed in liver disease. The POSITIVE TRIAL will randomise 100.000 subjects from the general population across 6 different European countries (Croatia, Denmark, Germany, Italy, Slovakia and Spain). Half will be screened for liver fibrosis using the digital tool and the other half will receive a standard approach to usual care. Patients in both groups who are found to have liver fibrosis will be offered treatment and counselling. The impact of screening on liver disease identification and patient outcomes will be evaluated. The results of the POSITIVE TRIAL will provide vital information for healthcare systems, governments and the healthcare industry.

This work package led by Odense University Hospital, and co-led by NOVO and Siemens includes the following LIVERAIM partners: FRCB-IDIBAPS, HCB, USAAR, UZSM, ISGLOBAL; UZH, UCHD, FDRH-BB, UNIPD, AOP; Echosens, Siemens, Roche, Sysmex, AstraZeneca, Boeheringer Ingelheim.

A top team of public health researchers will examine where, why and how liver disease detection is failing and deliver innovative and practical responses to this problem. A three-pronged approach will be taken to boost public awareness, strengthen healthcare practitioner knowledge and encourage government’s willingness to address an undervalued health and societal problem. Various roadmaps will be developed to ensure fairness, sustainability and inclusiveness across countries, populations and different socio-economic groups.

This work package led by the Barcelona Institute for Global Health, and co-led by AstraZeneca includes the following LIVERAIM partners: UNIPD, UZH, UMCU, OUH, UAB, UB, HCB, AOP, FDRB-BB, ELPA

The health economic impacts of liver disease are not well described. The team of health economists based in Zurich will model the current costs, the foreseeable costs without intervention and the benefits that LIVERAIM could bring forward.  These results will give a much-needed boost to the understanding of the importance of early detection programmes for Liver Disease.

This work package led by University of Zurich, and co-led by Sysmex includes the following LIVERAIM partners: FRCB-IDIBAPS, HCB, OUH, USAAR, UZSM, UCHD, FDRH-BB, UNIPD, AOP; ISGLOBAL, Siemens, Roche, Nordic, Echosens.

This work package aims to maximize the impact of the project and relative results and increase awareness about liver diseases. The LIVERAIM project will raise awareness across specialties, moving beyond hepatology and gastroenterology, to promote early recognition of liver disease. Alongside our patient associations partners, we will organise events and information days for patients and their families, to promote patient empowerment, and for the general population to increase awareness about liver diseases.

This work package led by University of Padova, and co-led by Gilead includes all LIVERAIM partners.

The combined team of the Fundació de Recerca Clínic Barcelona-Institut d’Investigacions Biomèdiques August Pi i Sunyer (FRCB-IDIBAPS), INNOVATION ACTA and ROCHE are the management team behind the LIVERAIM Consortium and project.  FRCB-IDIBAPS and INNOVATION ACTA take responsibility for the day-to-day management and communications with the team at IHI.  ROCHE is the leading representative for the Industry partners. Added to which there is a Steering Committee comprised of representatives from all partners participating in the project, whose main task will be to discuss the strategical direction of the project. The Consortium relies on external and neutral advice of the Scientific Advisory Board, the members of which are experts in the field of liver disease, general and family medicine and a non-medical member of the community.

The complexity of a project such as LIVERAIM that includes data and samples from a large number of patients from several countries in existing biobanks and prospective studies requires an in-depth understanding of ethical and legal issues. Key ethical issues include patient data collection and privacy, responsible development of AI tools and their use in healthcare, and collaboration between academic and industry partners. Further, the ultimate success of LIVERAIM depends on regulatory authorization and market access of the tools developed. The team led by University of Odense and Nordic Bioscience have years of experience implementing the stringent requisites demanded by this work package ensuring the regulatory and ethical obligations are adhered to by all partners.

This work package led by Odense University Hospital, and co-led by Nordic Bioscience includes all LIVERAIM partners.