Preclinical common data elements for general pharmacological studies (pharmacokinetic sample collection, tolerability, and drug administration). A report of the TASK3-WG1A General Pharmacology Working Group of the ILAE/AES Joint Translational Task Force

Lisa Coles; Patrick A. Forcelli; Karine Leclercq; Anna Maria Katsarou; Brian D. Klein; Heidrun Potschka; Rudiger Koehling; Lauren Harte-Hargrove; Aristea S. Galanopoulou; Cameron S. Metcalf

doi:10.1002/epi4.12721

Preclinical common data elements for general pharmacological studies (pharmacokinetic sample collection, tolerability, and drug administration). A report of the TASK3-WG1A General Pharmacology Working Group of the ILAE/AES Joint Translational Task Force

Lisa Coles, Patrick A. Forcelli, Karine Leclercq, Anna Maria Katsarou, Brian D. Klein, Heidrun Potschka, Rudiger Koehling, Lauren Harte-Hargrove, Aristea S. Galanopoulou, Cameron S. Metcalf

Experimental and Clinical Pharmacology

Research output: Contribution to journal › Article › peer-review

Abstract

Growing concerns over rigor and reproducibility of preclinical studies, including consistency across laboratories and translation to clinical populations, have triggered efforts to harmonize methodologies. This includes the first set of preclinical common data elements (CDEs) for epilepsy research studies, as well as Case Report Forms (CRFs) for widespread use in epilepsy research. The General Pharmacology Working Group of the ILAE/AES Task Force (TASK3-WG1A) has continued in this effort by adapting and refining CDEs/CRFs to address specific study design areas as they relate to preclinical drug screening: general pharmacology, pharmacokinetics (PK) and pharmacodynamics (PD), and tolerability. This work has expanded general pharmacology studies to include dose records, PK/PD, tolerability, and elements of rigor and reproducibility. Tolerability testing CRFs included rotarod and Irwin/Functional Observation Battery (FOB) assays. The material provided in the form of CRFs can be delivered for widespread use within the epilepsy research community.

Original language	English (US)
Journal	Epilepsia Open
DOIs	https://doi.org/10.1002/epi4.12721
State	Accepted/In press - 2023

Bibliographical note

Funding Information:
We acknowledge the International League Against Epilepsy (ILAE) and the American Epilepsy Society (AES) for sponsoring the activities of the ILAE/AES Joint Translational Task Force. We also acknowledge Lauren Harte‐Hargrove for converting CRFs to CDE charts. PA Forcelli acknowledges grant support by NIH R21NS125552, R01HD091994, and R01NS097762AS Galanopoulou acknowledges grant support by NIH U54 NS100064, R01 NS127524, R01 NS091170, American Epilepsy Society seed grant, the Heffer Family and the Segal Family Foundations, and the Abbe Goldstein/Joshua Lurie and Laurie Marsh/Dan Levitz families. CS Metcalf acknowledges grant support by HHSN271201600048C (NINDS). H Potschka acknowledges grant support by Deutsche Forschungsgemeinschaft FOR2591 PO681/9‐2 and PO681/12‐1.

Publisher Copyright:
© 2023 The Authors. Epilepsia Open published by Wiley Periodicals LLC on behalf of International League Against Epilepsy.

Keywords

animal model
case report form
common data element
pharmacology
preclinical

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Coles, L., Forcelli, P. A., Leclercq, K., Katsarou, A. M., Klein, B. D., Potschka, H., Koehling, R., Harte-Hargrove, L., Galanopoulou, A. S., & Metcalf, C. S. (Accepted/In press). Preclinical common data elements for general pharmacological studies (pharmacokinetic sample collection, tolerability, and drug administration). A report of the TASK3-WG1A General Pharmacology Working Group of the ILAE/AES Joint Translational Task Force. Epilepsia Open. https://doi.org/10.1002/epi4.12721

Preclinical common data elements for general pharmacological studies (pharmacokinetic sample collection, tolerability, and drug administration). A report of the TASK3-WG1A General Pharmacology Working Group of the ILAE/AES Joint Translational Task Force. / Coles, Lisa; Forcelli, Patrick A.; Leclercq, Karine et al.
In: Epilepsia Open, 2023.

Research output: Contribution to journal › Article › peer-review

Coles, L, Forcelli, PA, Leclercq, K, Katsarou, AM, Klein, BD, Potschka, H, Koehling, R, Harte-Hargrove, L, Galanopoulou, AS & Metcalf, CS 2023, 'Preclinical common data elements for general pharmacological studies (pharmacokinetic sample collection, tolerability, and drug administration). A report of the TASK3-WG1A General Pharmacology Working Group of the ILAE/AES Joint Translational Task Force', Epilepsia Open. https://doi.org/10.1002/epi4.12721

Coles L, Forcelli PA, Leclercq K, Katsarou AM, Klein BD, Potschka H et al. Preclinical common data elements for general pharmacological studies (pharmacokinetic sample collection, tolerability, and drug administration). A report of the TASK3-WG1A General Pharmacology Working Group of the ILAE/AES Joint Translational Task Force. Epilepsia Open. 2023. doi: 10.1002/epi4.12721

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abstract = "Growing concerns over rigor and reproducibility of preclinical studies, including consistency across laboratories and translation to clinical populations, have triggered efforts to harmonize methodologies. This includes the first set of preclinical common data elements (CDEs) for epilepsy research studies, as well as Case Report Forms (CRFs) for widespread use in epilepsy research. The General Pharmacology Working Group of the ILAE/AES Task Force (TASK3-WG1A) has continued in this effort by adapting and refining CDEs/CRFs to address specific study design areas as they relate to preclinical drug screening: general pharmacology, pharmacokinetics (PK) and pharmacodynamics (PD), and tolerability. This work has expanded general pharmacology studies to include dose records, PK/PD, tolerability, and elements of rigor and reproducibility. Tolerability testing CRFs included rotarod and Irwin/Functional Observation Battery (FOB) assays. The material provided in the form of CRFs can be delivered for widespread use within the epilepsy research community.",

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Preclinical common data elements for general pharmacological studies (pharmacokinetic sample collection, tolerability, and drug administration). A report of the TASK3-WG1A General Pharmacology Working Group of the ILAE/AES Joint Translational Task Force

Abstract

Bibliographical note

Keywords

PubMed: MeSH publication types

Access

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