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Liver safety assessment: required data elements and best practices for data collection and standardization in clinical trials.
Drug Saf. 2014 Nov; 37 Suppl 1:S19-31.DS

Abstract

A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials. In a breakout session, workshop attendees discussed necessary data elements and standards for the accurate measurement of DILI risk associated with new therapeutic agents in clinical trials. There was agreement that in order to achieve this goal the systematic acquisition of protocol-specified clinical measures and lab specimens from all study subjects is crucial. In addition, standard DILI terms that address the diverse clinical and pathologic signatures of DILI were considered essential. There was a strong consensus that clinical and lab analyses necessary for the evaluation of cases of acute liver injury should be consistent with the US Food and Drug Administration (FDA) guidance on pre-marketing risk assessment of DILI in clinical trials issued in 2009. A recommendation that liver injury case review and management be guided by clinicians with hepatologic expertise was made. Of note, there was agreement that emerging DILI signals should prompt the systematic collection of candidate pharmacogenomic, proteomic and/or metabonomic biomarkers from all study subjects. The use of emerging standardized clinical terminology, CRFs and graphic tools for data review to enable harmonization across clinical trials was strongly encouraged. Many of the recommendations made in the breakout session are in alignment with those made in the other parallel sessions on methodology to assess clinical liver safety data, causality assessment for suspected DILI, and liver safety assessment in special populations (hepatitis B, C, and oncology trials). Nonetheless, a few outstanding issues remain for future consideration.

Authors+Show Affiliations

Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA, mark.avigan@fda.hhs.gov.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

25352325

Citation

Avigan, Mark I., et al. "Liver Safety Assessment: Required Data Elements and Best Practices for Data Collection and Standardization in Clinical Trials." Drug Safety, vol. 37 Suppl 1, 2014, pp. S19-31.
Avigan MI, Bjornsson ES, Pasanen M, et al. Liver safety assessment: required data elements and best practices for data collection and standardization in clinical trials. Drug Saf. 2014;37 Suppl 1:S19-31.
Avigan, M. I., Bjornsson, E. S., Pasanen, M., Cooper, C., Andrade, R. J., Watkins, P. B., Lewis, J. H., & Merz, M. (2014). Liver safety assessment: required data elements and best practices for data collection and standardization in clinical trials. Drug Safety, 37 Suppl 1, S19-31. https://doi.org/10.1007/s40264-014-0183-6
Avigan MI, et al. Liver Safety Assessment: Required Data Elements and Best Practices for Data Collection and Standardization in Clinical Trials. Drug Saf. 2014;37 Suppl 1:S19-31. PubMed PMID: 25352325.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Liver safety assessment: required data elements and best practices for data collection and standardization in clinical trials. AU - Avigan,Mark I, AU - Bjornsson,Einar S, AU - Pasanen,Markku, AU - Cooper,Charles, AU - Andrade,Raul J, AU - Watkins,Paul B, AU - Lewis,James H, AU - Merz,Michael, PY - 2014/10/30/entrez PY - 2014/10/30/pubmed PY - 2015/6/30/medline SP - S19 EP - 31 JF - Drug safety JO - Drug Saf VL - 37 Suppl 1 N2 - A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials. In a breakout session, workshop attendees discussed necessary data elements and standards for the accurate measurement of DILI risk associated with new therapeutic agents in clinical trials. There was agreement that in order to achieve this goal the systematic acquisition of protocol-specified clinical measures and lab specimens from all study subjects is crucial. In addition, standard DILI terms that address the diverse clinical and pathologic signatures of DILI were considered essential. There was a strong consensus that clinical and lab analyses necessary for the evaluation of cases of acute liver injury should be consistent with the US Food and Drug Administration (FDA) guidance on pre-marketing risk assessment of DILI in clinical trials issued in 2009. A recommendation that liver injury case review and management be guided by clinicians with hepatologic expertise was made. Of note, there was agreement that emerging DILI signals should prompt the systematic collection of candidate pharmacogenomic, proteomic and/or metabonomic biomarkers from all study subjects. The use of emerging standardized clinical terminology, CRFs and graphic tools for data review to enable harmonization across clinical trials was strongly encouraged. Many of the recommendations made in the breakout session are in alignment with those made in the other parallel sessions on methodology to assess clinical liver safety data, causality assessment for suspected DILI, and liver safety assessment in special populations (hepatitis B, C, and oncology trials). Nonetheless, a few outstanding issues remain for future consideration. SN - 1179-1942 UR - https://www.unboundmedicine.com/medline/citation/25352325/Liver_safety_assessment:_required_data_elements_and_best_practices_for_data_collection_and_standardization_in_clinical_trials_ L2 - https://dx.doi.org/10.1007/s40264-014-0183-6 DB - PRIME DP - Unbound Medicine ER -