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

Niina Lapinlampi; Esbjörn Melin; Eleonora Aronica; Jens P. Bankstahl; Albert Becker; Cristophe Bernard; Jan A. Gorter; Olli Gröhn; Anu Lipsanen; Katarzyna Lukasiuk; Wolfgang Löscher; Jussi Paananen; Teresa Ravizza; Paolo Roncon; Michele Simonato; Annamaria Vezzani; Merab Kokaia; Asla Pitkänen

doi:10.1016/j.eplepsyres.2016.11.010

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

Niina Lapinlampi, Esbjörn Melin, Eleonora Aronica, Jens P. Bankstahl, Albert Becker, Cristophe Bernard, Jan A. Gorter, Olli Gröhn, Anu Lipsanen, Katarzyna Lukasiuk, Wolfgang Löscher, Jussi Paananen, Teresa Ravizza, Paolo Roncon, Michele Simonato, Annamaria Vezzani, Merab Kokaia, Asla Pitkänen

Epilepsy Center

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

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
DOIs	https://doi.org/10.1016/j.eplepsyres.2016.11.010
Publication status	Published - 2017 Jan 1

Subject classification (UKÄ)

Neurology
Other Computer and Information Science

Free keywords

Common data element
Data management
Database
Epilepsy
Epileptogenesis

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10.1016/j.eplepsyres.2016.11.010

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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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T2 - Remedy to cure underpowered preclinical studies

AU - Lapinlampi, Niina

AU - Melin, Esbjörn

AU - Aronica, Eleonora

AU - Bankstahl, Jens P.

AU - Becker, Albert

AU - Bernard, Cristophe

AU - Gorter, Jan A.

AU - Gröhn, Olli

AU - Lipsanen, Anu

AU - Lukasiuk, Katarzyna

AU - Löscher, Wolfgang

AU - Paananen, Jussi

AU - Ravizza, Teresa

AU - Roncon, Paolo

AU - Simonato, Michele

AU - Vezzani, Annamaria

AU - Kokaia, Merab

AU - Pitkänen, Asla

PY - 2017/1/1

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N2 - 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.

AB - 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.

KW - Common data element

KW - Data management

KW - Database

KW - Epilepsy

KW - Epileptogenesis

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U2 - 10.1016/j.eplepsyres.2016.11.010

DO - 10.1016/j.eplepsyres.2016.11.010

M3 - Article

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AN - SCOPUS:85007154568

SN - 0920-1211

VL - 129

SP - 87

EP - 90

JO - Epilepsy Research

JF - Epilepsy Research

ER -

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

Abstract

Subject classification (UKÄ)

Free keywords

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Advancing gene therapy for epilepsy. Translational pre-clinical studies with neuropeptide Y and glial cell-line derived neurotrophic factor.

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