A companion to the preclinical common data elements for rigor, reproducibility and transparency in basic and translational epilepsy research. A report of the TASK3‐WG1A: Pharmacology Working Group of the ILAE/AES Joint Translational Task Force

Abstract Rigorous and transparent procedures in preclinical epilepsy research studies are important to permit assessing the reproducibility of their findings and derisk their translation into the clinic. The General Pharmacology Working Group of the ILAE/AES Task Force (TASK3‐WG1A) developed common...

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Main Authors: Brian D. Klein, Lauren Harte‐Hargrove, Wenzhu Mowrey, Aristea S. Galanopoulou, Cameron S. Metcalf, Lisa Coles, Patrick A. Forcelli, Anna‐Maria Katsarou, Rudiger Koehling, Karine Leclercq, Heidrun Potschka, TASK3‐WG1A working group
Format: Article
Language:English
Published: Wiley 2025-08-01
Series:Epilepsia Open
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Online Access:https://doi.org/10.1002/epi4.70053
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author Brian D. Klein
Lauren Harte‐Hargrove
Wenzhu Mowrey
Aristea S. Galanopoulou
Cameron S. Metcalf
Lisa Coles
Patrick A. Forcelli
Anna‐Maria Katsarou
Rudiger Koehling
Karine Leclercq
Heidrun Potschka
TASK3‐WG1A working group
author_facet Brian D. Klein
Lauren Harte‐Hargrove
Wenzhu Mowrey
Aristea S. Galanopoulou
Cameron S. Metcalf
Lisa Coles
Patrick A. Forcelli
Anna‐Maria Katsarou
Rudiger Koehling
Karine Leclercq
Heidrun Potschka
TASK3‐WG1A working group
author_sort Brian D. Klein
collection DOAJ
description Abstract Rigorous and transparent procedures in preclinical epilepsy research studies are important to permit assessing the reproducibility of their findings and derisk their translation into the clinic. The General Pharmacology Working Group of the ILAE/AES Task Force (TASK3‐WG1A) developed common data elements (CDEs) addressing rigor and transparency and organized the CDEs into a case report form (CRF) to provide guidance on study planning, conduct, analysis, and reporting. CDEs specifying the type of study, use of inclusion–exclusion criteria, quantitative methods, randomization, blinding, and masking were developed and defined. This companion paper provides additional information and interpretation on the use of the rigor and transparency CDEs to assist preclinical investigators. Adoption of these CDEs and CRF will enhance data quality and transparent reporting to improve the reuse of preclinical data sets and the successful translation of preclinical epilepsy research. The materials provided in the form of CDEs, CRF, and this companion paper can be used in the research community for training purposes and to promote more rigorous conduct and transparent reporting of basic and translational epilepsy research. Plain Language Summary The purpose of the Common Data Elements described in this companion paper is to improve the rigor, reproducibility, and transparency of basic and translational epilepsy research studies. Enhancing these important elements of preclinical epilepsy research will facilitate data sharing and comparisons between research laboratories and potentially the reliability of translating preclinical research findings to clinical studies that reduce the burden of disease for individuals with epilepsy.
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spelling doaj-art-dde367a1f5514daaaf1e01681f0fb8052025-08-25T10:12:58ZengWileyEpilepsia Open2470-92392025-08-0110S1S18S3910.1002/epi4.70053A companion to the preclinical common data elements for rigor, reproducibility and transparency in basic and translational epilepsy research. A report of the TASK3‐WG1A: Pharmacology Working Group of the ILAE/AES Joint Translational Task ForceBrian D. Klein0Lauren Harte‐Hargrove1Wenzhu Mowrey2Aristea S. Galanopoulou3Cameron S. Metcalf4Lisa Coles5Patrick A. Forcelli6Anna‐Maria Katsarou7Rudiger Koehling8Karine Leclercq9Heidrun Potschka10TASK3‐WG1A working groupNational Institute of Neurological Disorders and Stroke National Institutes of Health Bethesda Maryland USACURE Epilepsy Chicago Illinois USADivision of Biostatistics Department of Epidemiology and Population Health Albert Einstein College of Medicine Bronx New York USASaul R Korey Department of Neurology, Isabelle Rapin Division of Child Neurology, Dominick P. Purpura Department of Neuroscience, Laboratory of Developmental Epilepsy Albert Einstein College of Medicine Bronx New York USACollege of Pharmacy, Department of Pharmacology and Toxicology The University of Utah Salt Lake City Utah USADepartment of Experimental and Clinical Pharmacology The University of Minnesota, College of Pharmacy Minneapolis Minnesota USADepartment of Pharmacology & Physiology, Department of Neuroscience Georgetown University Washington District of Columbia USALaboratory of Developmental Epilepsy, Saul R. Korey Department of Neurology Albert Einstein College of Medicine Bronx New York USAOscar‐Langendorff‐Institute of Physiology Rostock University Medical Center Rostock GermanyPatient Solutions Department UCB Pharma Braine‐l'Alleud BelgiumInstitute of Pharmacology, Toxicology, and Pharmacy Ludwig‐Maximilians‐Universität Munich GermanyAbstract Rigorous and transparent procedures in preclinical epilepsy research studies are important to permit assessing the reproducibility of their findings and derisk their translation into the clinic. The General Pharmacology Working Group of the ILAE/AES Task Force (TASK3‐WG1A) developed common data elements (CDEs) addressing rigor and transparency and organized the CDEs into a case report form (CRF) to provide guidance on study planning, conduct, analysis, and reporting. CDEs specifying the type of study, use of inclusion–exclusion criteria, quantitative methods, randomization, blinding, and masking were developed and defined. This companion paper provides additional information and interpretation on the use of the rigor and transparency CDEs to assist preclinical investigators. Adoption of these CDEs and CRF will enhance data quality and transparent reporting to improve the reuse of preclinical data sets and the successful translation of preclinical epilepsy research. The materials provided in the form of CDEs, CRF, and this companion paper can be used in the research community for training purposes and to promote more rigorous conduct and transparent reporting of basic and translational epilepsy research. Plain Language Summary The purpose of the Common Data Elements described in this companion paper is to improve the rigor, reproducibility, and transparency of basic and translational epilepsy research studies. Enhancing these important elements of preclinical epilepsy research will facilitate data sharing and comparisons between research laboratories and potentially the reliability of translating preclinical research findings to clinical studies that reduce the burden of disease for individuals with epilepsy.https://doi.org/10.1002/epi4.70053common data elementspreclinicalreproducibilityrigortransparency
spellingShingle Brian D. Klein
Lauren Harte‐Hargrove
Wenzhu Mowrey
Aristea S. Galanopoulou
Cameron S. Metcalf
Lisa Coles
Patrick A. Forcelli
Anna‐Maria Katsarou
Rudiger Koehling
Karine Leclercq
Heidrun Potschka
TASK3‐WG1A working group
A companion to the preclinical common data elements for rigor, reproducibility and transparency in basic and translational epilepsy research. A report of the TASK3‐WG1A: Pharmacology Working Group of the ILAE/AES Joint Translational Task Force
Epilepsia Open
common data elements
preclinical
reproducibility
rigor
transparency
title A companion to the preclinical common data elements for rigor, reproducibility and transparency in basic and translational epilepsy research. A report of the TASK3‐WG1A: Pharmacology Working Group of the ILAE/AES Joint Translational Task Force
title_full A companion to the preclinical common data elements for rigor, reproducibility and transparency in basic and translational epilepsy research. A report of the TASK3‐WG1A: Pharmacology Working Group of the ILAE/AES Joint Translational Task Force
title_fullStr A companion to the preclinical common data elements for rigor, reproducibility and transparency in basic and translational epilepsy research. A report of the TASK3‐WG1A: Pharmacology Working Group of the ILAE/AES Joint Translational Task Force
title_full_unstemmed A companion to the preclinical common data elements for rigor, reproducibility and transparency in basic and translational epilepsy research. A report of the TASK3‐WG1A: Pharmacology Working Group of the ILAE/AES Joint Translational Task Force
title_short A companion to the preclinical common data elements for rigor, reproducibility and transparency in basic and translational epilepsy research. A report of the TASK3‐WG1A: Pharmacology Working Group of the ILAE/AES Joint Translational Task Force
title_sort companion to the preclinical common data elements for rigor reproducibility and transparency in basic and translational epilepsy research a report of the task3 wg1a pharmacology working group of the ilae aes joint translational task force
topic common data elements
preclinical
reproducibility
rigor
transparency
url https://doi.org/10.1002/epi4.70053
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