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Epilepsy Res. 2017 Jan;129:87-90. doi: 10.1016/j.eplepsyres.2016.11.010. Epub 2016 Nov 22.

Common data elements and data management: Remedy to cure underpowered preclinical studies.

Author information

1
Department of Neurobiology, A. I. Virtanen Institute for Molecular Sciences, University of Eastern Finland, PO Box 1627, FI-70211 Kuopio, Finland.
2
Epilepsy Center, Wallenberg Neuroscience Center, Lund University, Lund, Sweden.
3
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.
4
Department of Nuclear Medicine, Hannover Medical School, Hannover, Germany.
5
Translational Epilepsy Research Section, University of Bonn Medical Center, Bonn, Germany.
6
Université d'Aix Marseille, Marseille, France.
7
Laboratory of Epileptogenesis, Nencki Institute of Experimental Biology of Polish Academy of Sciences, Warsaw, Poland.
8
Department of Pharmacology, Toxicology, and Pharmacy, University of Veterinary Medicine, Hannover, Germany.
9
Institute of Biomedicine, University of Eastern Finland, Kuopio, Finland.
10
Department of Neuroscience, Experimental Neurology, Mario Negri Institute for Pharmacological Research, Milan, Italy.
11
University of Ferrara and University Vita-Salute San Raffaele, Milan, Italy.
12
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.

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.

KEYWORDS:

Common data element; Data management; Database; Epilepsy; Epileptogenesis

[Indexed for MEDLINE]

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