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Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials
Causality assessment for suspected drug-induced liver injury (DILI) during drug development and following approval is challenging. The IQ DILI Causality Working Group (CWG), in collaboration with academic and regulatory subject matter experts (SMEs), developed this manuscript with the following obje...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8184702/ https://www.ncbi.nlm.nih.gov/pubmed/33725335 http://dx.doi.org/10.1007/s40264-021-01051-5 |
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author | Hey-Hadavi, Juliana Seekins, Daniel Palmer, Melissa Coffey, Denise Caminis, John Abdullaev, Sandzhar Patwardhan, Meenal Tyler, Haifa Raheja, Ritu Stanley, Ann Marie Pineda-Salgado, Liliam Bourdet, David L. Andrade, Raul J. Hayashi, Paul H. Dimick-Santos, Lara Rockey, Don C. Estilo, Alvin |
author_facet | Hey-Hadavi, Juliana Seekins, Daniel Palmer, Melissa Coffey, Denise Caminis, John Abdullaev, Sandzhar Patwardhan, Meenal Tyler, Haifa Raheja, Ritu Stanley, Ann Marie Pineda-Salgado, Liliam Bourdet, David L. Andrade, Raul J. Hayashi, Paul H. Dimick-Santos, Lara Rockey, Don C. Estilo, Alvin |
author_sort | Hey-Hadavi, Juliana |
collection | PubMed |
description | Causality assessment for suspected drug-induced liver injury (DILI) during drug development and following approval is challenging. The IQ DILI Causality Working Group (CWG), in collaboration with academic and regulatory subject matter experts (SMEs), developed this manuscript with the following objectives: (1) understand and describe current practices; (2) evaluate the utility of new tools/methods/practice guidelines; (3) propose a minimal data set needed to assess causality; (4) define best practices; and (5) promote a more structured and universal approach to DILI causality assessment for clinical development. To better understand current practices, the CWG performed a literature review, took a survey of member companies, and collaborated with SMEs. Areas of focus included best practices for causality assessment during clinical development, utility of adjudication committees, and proposals for potential new avenues to improve causality assessment. The survey and literature review provided renewed understanding of the complexity and challenges of DILI causality assessment as well as the use of non-standardized approaches. Potential areas identified for consistency and standardization included role and membership of adjudication committees, standardized minimum dataset, updated assessment tools, and best practices for liver biopsy and rechallenge in the setting of DILI. Adjudication committees comprised of SMEs (i.e., utilizing expert opinion) remain the standard for DILI causality assessment. A variety of working groups continue to make progress in pursuing new tools to assist with DILI causality assessment. The minimum dataset deemed adequate for causality assessment provides a path forward for standardization of data collection in the setting of DILI. Continued progress is necessary to optimize and advance innovative tools necessary for the scientific, pharmaceutical, and regulatory community. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40264-021-01051-5. |
format | Online Article Text |
id | pubmed-8184702 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-81847022021-06-25 Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials Hey-Hadavi, Juliana Seekins, Daniel Palmer, Melissa Coffey, Denise Caminis, John Abdullaev, Sandzhar Patwardhan, Meenal Tyler, Haifa Raheja, Ritu Stanley, Ann Marie Pineda-Salgado, Liliam Bourdet, David L. Andrade, Raul J. Hayashi, Paul H. Dimick-Santos, Lara Rockey, Don C. Estilo, Alvin Drug Saf Leading Article Causality assessment for suspected drug-induced liver injury (DILI) during drug development and following approval is challenging. The IQ DILI Causality Working Group (CWG), in collaboration with academic and regulatory subject matter experts (SMEs), developed this manuscript with the following objectives: (1) understand and describe current practices; (2) evaluate the utility of new tools/methods/practice guidelines; (3) propose a minimal data set needed to assess causality; (4) define best practices; and (5) promote a more structured and universal approach to DILI causality assessment for clinical development. To better understand current practices, the CWG performed a literature review, took a survey of member companies, and collaborated with SMEs. Areas of focus included best practices for causality assessment during clinical development, utility of adjudication committees, and proposals for potential new avenues to improve causality assessment. The survey and literature review provided renewed understanding of the complexity and challenges of DILI causality assessment as well as the use of non-standardized approaches. Potential areas identified for consistency and standardization included role and membership of adjudication committees, standardized minimum dataset, updated assessment tools, and best practices for liver biopsy and rechallenge in the setting of DILI. Adjudication committees comprised of SMEs (i.e., utilizing expert opinion) remain the standard for DILI causality assessment. A variety of working groups continue to make progress in pursuing new tools to assist with DILI causality assessment. The minimum dataset deemed adequate for causality assessment provides a path forward for standardization of data collection in the setting of DILI. Continued progress is necessary to optimize and advance innovative tools necessary for the scientific, pharmaceutical, and regulatory community. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40264-021-01051-5. Springer International Publishing 2021-03-16 2021 /pmc/articles/PMC8184702/ /pubmed/33725335 http://dx.doi.org/10.1007/s40264-021-01051-5 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Leading Article Hey-Hadavi, Juliana Seekins, Daniel Palmer, Melissa Coffey, Denise Caminis, John Abdullaev, Sandzhar Patwardhan, Meenal Tyler, Haifa Raheja, Ritu Stanley, Ann Marie Pineda-Salgado, Liliam Bourdet, David L. Andrade, Raul J. Hayashi, Paul H. Dimick-Santos, Lara Rockey, Don C. Estilo, Alvin Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials |
title | Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials |
title_full | Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials |
title_fullStr | Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials |
title_full_unstemmed | Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials |
title_short | Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials |
title_sort | overview of causality assessment for drug-induced liver injury (dili) in clinical trials |
topic | Leading Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8184702/ https://www.ncbi.nlm.nih.gov/pubmed/33725335 http://dx.doi.org/10.1007/s40264-021-01051-5 |
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