TY - JOUR
T1 - Roadmap to DILI research in Europe. A proposal from COST action ProEuroDILINet
AU - Lucena, M. I.
AU - Villanueva-Paz, M.
AU - Alvarez-Alvarez, I.
AU - Aithal, G. P.
AU - Björnsson, E. S.
AU - Cakan-Akdogan, G.
AU - Cubero, F. J.
AU - Esteves, F.
AU - Falcon-Perez, J. M.
AU - Fromenty, B.
AU - Garcia-Ruiz, C.
AU - Grove, J. I.
AU - Konu, O.
AU - Kranendonk, M.
AU - Kullak-Ublick, G. A.
AU - Miranda, J. P.
AU - Remesal-Doblado, A.
AU - Sancho-Bru, P.
AU - Nelson, L.
AU - Andrade, R. J.
AU - Daly, A. K.
AU - Fernandez-Checa, J. C.
N1 - Funding Information:
The present study has been supported by grants from Instituto de Salud Carlos III (ISCIII) (contract numbers: PID2022–140169OB-C21; PI21/01248; PI19/00883) and from Consejería de Salud de Andalucía (contract number: PEMP-0127–2020, Spain), cofounded by the European Union. This research was funded by HORIZON-HLTH-2022-STAYHLTH-02, grant number 101095679. Funded by the European Union. Views and opinions expressed are however those of the authors only and do not necessarily reflect those of the European Union. Neither the European Union nor the granting authority can be held responsible for them. MK was partially supported by Grant UID/BIM/0009/2020 of the Portuguese Fundação para a Ciência e a Tecnologia (FCT). MVP and IAA hold Sara Borrell research contracts from ISCIII (CD21/00198 and CD20/00083, respectively). This research was supported by CIBERehd – Consorcio Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Instituto de Salud Carlos III, Ministerio de Ciencia e Innovación and Unión Europea – European Regional Development Fund. JIG and GPA are supported by NIHR Nottingham Biomedical Research Centre [NIHR203310]. The views expressed are those of the authors and not necessarily those of the National Health Service (NHS), the NIHR or the Department of Health. This publication is based upon work from COST Action “CA17112—Prospective European Drug-Induced Liver Injury Network” supported by COST (European Cooperation in Science and Technology); www.cost.eu.
Funding Information:
The present study has been supported by grants from Instituto de Salud Carlos III (ISCIII) (contract numbers: PID2022–140169OB-C21 ; PI21/01248 ; PI19/00883 ) and from Consejería de Salud de Andalucía (contract number: PEMP-0127–2020 , Spain), cofounded by the European Union. This research was funded by HORIZON-HLTH-2022-STAYHLTH-02 , grant number 101095679 . Funded by the European Union . Views and opinions expressed are however those of the authors only and do not necessarily reflect those of the European Union. Neither the European Union nor the granting authority can be held responsible for them. MK was partially supported by Grant UID/BIM/0009/2020 of the Portuguese Fundação para a Ciência e a Tecnologia ( FCT ). MVP and IAA hold Sara Borrell research contracts from ISCIII ( CD21/00198 and CD20/00083 , respectively). This research was supported by CIBERehd – Consorcio Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Instituto de Salud Carlos III, Ministerio de Ciencia e Innovación and Unión Europea – European Regional Development Fund . JIG and GPA are supported by NIHR Nottingham Biomedical Research Centre [ NIHR203310 ]. The views expressed are those of the authors and not necessarily those of the National Health Service (NHS), the NIHR or the Department of Health. This publication is based upon work from COST Action “CA17112—Prospective European Drug-Induced Liver Injury Network” supported by COST (European Cooperation in Science and Technology); www.cost.eu .
Publisher Copyright:
© 2024 The Authors
PY - 2024/2
Y1 - 2024/2
N2 - In the current article the aims for a constructive way forward in Drug-Induced Liver Injury (DILI) are to highlight the most important priorities in research and clinical science, therefore supporting a more informed, focused, and better funded future for European DILI research. This Roadmap aims to identify key challenges, define a shared vision across all stakeholders for the opportunities to overcome these challenges and propose a high-quality research program to achieve progress on the prediction, prevention, diagnosis and management of this condition and impact on healthcare practice in the field of DILI. This will involve 1. Creation of a database encompassing optimised case report form for prospectively identified DILI cases with well-characterised controls with competing diagnoses, biological samples, and imaging data; 2. Establishing of preclinical models to improve the assessment and prediction of hepatotoxicity in humans to guide future drug safety testing; 3. Emphasis on implementation science and 4. Enhanced collaboration between drug-developers, clinicians and regulatory scientists. This proposed operational framework will advance DILI research and may bring together basic, applied, translational and clinical research in DILI.
AB - In the current article the aims for a constructive way forward in Drug-Induced Liver Injury (DILI) are to highlight the most important priorities in research and clinical science, therefore supporting a more informed, focused, and better funded future for European DILI research. This Roadmap aims to identify key challenges, define a shared vision across all stakeholders for the opportunities to overcome these challenges and propose a high-quality research program to achieve progress on the prediction, prevention, diagnosis and management of this condition and impact on healthcare practice in the field of DILI. This will involve 1. Creation of a database encompassing optimised case report form for prospectively identified DILI cases with well-characterised controls with competing diagnoses, biological samples, and imaging data; 2. Establishing of preclinical models to improve the assessment and prediction of hepatotoxicity in humans to guide future drug safety testing; 3. Emphasis on implementation science and 4. Enhanced collaboration between drug-developers, clinicians and regulatory scientists. This proposed operational framework will advance DILI research and may bring together basic, applied, translational and clinical research in DILI.
KW - 3D culture
KW - Artificial intelligence
KW - Atypical DILI phenotypes
KW - Clinical trials
KW - DILI prediction
KW - DILI risk stratification
KW - Drug safety
KW - Extracellular vesicles
KW - Familial studies
KW - Health care
KW - Humanized Mouse Models
KW - Idiosyncratic Drug-induced liver injury
KW - Integrative database
KW - Integrative multi-scale data
KW - Networking
KW - Organ-on-a-chip
KW - Pharmacogenetic studies
KW - Preclinical models
KW - Prognostic biomarkers
KW - Regulatory
KW - Zebrafish model
UR - http://www.scopus.com/inward/record.url?scp=85181835334&partnerID=8YFLogxK
U2 - 10.1016/j.phrs.2023.107046
DO - 10.1016/j.phrs.2023.107046
M3 - Article
C2 - 38159783
AN - SCOPUS:85181835334
SN - 1043-6618
VL - 200
JO - Pharmacological Research
JF - Pharmacological Research
M1 - 107046
ER -