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

N. Lapinlampi; E. Melin; E. Aronica; J.P. Bankstahl; A. Becker; C. Bernard; J.A. Gorter; O. Gröhn; A. Lipsanen; K. Lukasiuk; W. Löscher; J. Paananen; T. Ravizza; P. Roncon; M. Simonato; A. Vezzani; M. Kokaia; A. Pitkänen

doi:https://doi.org/10.1016/j.eplepsyres.2016.11.010

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

N. Lapinlampi, E. Melin, E. Aronica, J.P. Bankstahl, A. Becker, C. Bernard, J.A. Gorter, O. Gröhn, A. Lipsanen, K. Lukasiuk, W. Löscher, J. Paananen, T. Ravizza, P. Roncon, M. Simonato, A. Vezzani, M. Kokaia, A. Pitkänen

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

32 Citations (Scopus)

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.

Original language	English
Pages (from-to)	87-90
Number of pages	4
Journal	Epilepsy Research
Volume	129
Early online date	22 Nov 2016
DOIs	https://doi.org/10.1016/j.eplepsyres.2016.11.010
Publication status	Published - Jan 2017

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https://pure.uva.nl/ws/files/18055339/Common_data_elements_and_data_management.pdf

Cite this

Lapinlampi, N., Melin, E., Aronica, E., Bankstahl, J. P., Becker, A., Bernard, C., Gorter, J. A., Gröhn, O., Lipsanen, A., Lukasiuk, K., Löscher, W., Paananen, J., Ravizza, T., Roncon, P., Simonato, M., Vezzani, A., Kokaia, M., & Pitkänen, A. (2017). Common data elements and data management: Remedy to cure underpowered preclinical studies. Epilepsy Research, 129, 87-90. https://doi.org/10.1016/j.eplepsyres.2016.11.010

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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.",

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Lapinlampi, N, Melin, E, Aronica, E, Bankstahl, JP, Becker, A, Bernard, C, Gorter, JA, Gröhn, O, Lipsanen, A, Lukasiuk, K, Löscher, W, Paananen, J, Ravizza, T, Roncon, P, Simonato, M, Vezzani, A, Kokaia, M & Pitkänen, A 2017, 'Common data elements and data management: Remedy to cure underpowered preclinical studies', Epilepsy Research, vol. 129, pp. 87-90. https://doi.org/10.1016/j.eplepsyres.2016.11.010

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AU - Lukasiuk, K.

AU - Löscher, W.

AU - Paananen, J.

AU - Ravizza, T.

AU - Roncon, P.

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