title: Common data elements and data management: Remedy to cure underpowered preclinical studies.
abstract: Lack of translation of data obtained in preclinical trials to clinic has kindled researchers to develop new methodologies to increase the power and reproducibility of preclinical studies. One approach relates to harmonization of data collection and analysis, and has been used for a long time in clinical studies testing anti-seizure drugs. EPITARGET is a European Union FP7-funded research consortium composed of 18 partners from 9 countries. Its main research objective is to identify biomarkers and develop treatments for epileptogenesis. As the first step of harmonization of procedures between laboratories, EPITARGET established working groups for designing project-tailored common data elements (CDEs) and case report forms (CRFs) to be used in data collection and analysis. Eight major modules of CRFs were developed, presenting >1000 data points for each animal. EPITARGET presents the first single-project effort for harmonization of preclinical data collection and analysis in epilepsy research. EPITARGET is also anticipating the future challenges and requirements in a larger-scale preclinical harmonization of epilepsy studies, including training, data management expertise, cost, location, data safety and continuity of data repositories during and after funding period, and incentives motivating for the use of CDEs.
authors.affiliation: Department of Neurobiology, A. I. Virtanen Institute for Molecular Sciences, University of Eastern Finland, PO Box 1627, FI-70211 Kuopio, Finland.
authors.forename: Niina
authors.initials: N
authors.lastname: Lapinlampi
authors.affiliation: Epilepsy Center, Wallenberg Neuroscience Center, Lund University, Lund, Sweden.
authors.forename: Esbjörn
authors.initials: E
authors.lastname: Melin
authors.affiliation: Academic Medical Center, Dept (Neuro)Pathology and Center for Neuroscience, Swammerdam Institute for Life Sciences, University of Amsterdam, Amsterdam, Stichting Epilepsie Instellingen Nederland, Heemstede, The Netherlands.
authors.forename: Eleonora
authors.initials: E
authors.lastname: Aronica
authors.affiliation: Department of Nuclear Medicine, Hannover Medical School, Hannover, Germany.
authors.forename: Jens P
authors.initials: JP
authors.lastname: Bankstahl
authors.affiliation: Translational Epilepsy Research Section, University of Bonn Medical Center, Bonn, Germany.
authors.forename: Albert
authors.initials: A
authors.lastname: Becker
authors.affiliation: Université d'Aix Marseille, Marseille, France.
authors.forename: Cristophe
authors.initials: C
authors.lastname: Bernard
authors.affiliation: Academic Medical Center, Dept (Neuro)Pathology and Center for Neuroscience, Swammerdam Institute for Life Sciences, University of Amsterdam, Amsterdam, Stichting Epilepsie Instellingen Nederland, Heemstede, The Netherlands.
authors.forename: Jan A
authors.initials: JA
authors.lastname: Gorter
authors.affiliation: Department of Neurobiology, A. I. Virtanen Institute for Molecular Sciences, University of Eastern Finland, PO Box 1627, FI-70211 Kuopio, Finland.
authors.forename: Olli
authors.initials: O
authors.lastname: Gröhn
authors.affiliation: Department of Neurobiology, A. I. Virtanen Institute for Molecular Sciences, University of Eastern Finland, PO Box 1627, FI-70211 Kuopio, Finland.
authors.forename: Anu
authors.initials: A
authors.lastname: Lipsanen
authors.affiliation: Laboratory of Epileptogenesis, Nencki Institute of Experimental Biology of Polish Academy of Sciences, Warsaw, Poland.
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Lukasiuk
authors.affiliation: Department of Pharmacology, Toxicology, and Pharmacy, University of Veterinary Medicine, Hannover, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Löscher
authors.affiliation: Institute of Biomedicine, University of Eastern Finland, Kuopio, Finland.
authors.forename: Jussi
authors.initials: J
authors.lastname: Paananen
authors.affiliation: Department of Neuroscience, Experimental Neurology, Mario Negri Institute for Pharmacological Research, Milan, Italy.
authors.forename: Teresa
authors.initials: T
authors.lastname: Ravizza
authors.affiliation: University of Ferrara and University Vita-Salute San Raffaele, Milan, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Roncon
authors.affiliation: University of Ferrara and University Vita-Salute San Raffaele, Milan, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Simonato
authors.affiliation: Department of Neuroscience, Experimental Neurology, Mario Negri Institute for Pharmacological Research, Milan, Italy.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Vezzani
authors.affiliation: Epilepsy Center, Wallenberg Neuroscience Center, Lund University, Lund, Sweden.
authors.forename: Merab
authors.initials: M
authors.lastname: Kokaia
authors.affiliation: Department of Neurobiology, A. I. Virtanen Institute for Molecular Sciences, University of Eastern Finland, PO Box 1627, FI-70211 Kuopio, Finland. Electronic address: asla.pitkanen@uef.fi.
authors.forename: Asla
authors.initials: A
authors.lastname: Pitkänen
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000032:analysis; D035843:Biomedical Research / Q000592:standards / Q000706:statistics & numerical data; D065709:Common Data Elements / Q000592:standards; D003627:Data Interpretation, Statistical; D003628:Database Management Systems; D004827:Epilepsy / Q000188:drug therapy / Q000378:metabolism; D005060:Europe
chemical_list: D015415:Biomarkers
keywords: Common data element; Data management; Database; Epilepsy; Epileptogenesis