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

Lapinlampi, Niina; Melin, Esbjörn LU ; Aronica, Eleonora; Bankstahl, Jens P.; Becker, Albert; Bernard, Cristophe; Gorter, Jan A.; Gröhn, Olli; Lipsanen, Anu and Lukasiuk, Katarzyna, et al. (2017) In Epilepsy Research 129. p.87-90
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... (More)

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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published
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keywords
Common data element, Data management, Database, Epilepsy, Epileptogenesis
in
Epilepsy Research
volume
129
pages
4 pages
publisher
Elsevier
external identifiers
  • scopus:85007154568
  • wos:000394634300014
ISSN
0920-1211
DOI
10.1016/j.eplepsyres.2016.11.010
language
English
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yes
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eae21460-d657-4e7a-99ac-5327a6d74479
date added to LUP
2017-01-16 11:17:57
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2018-01-07 11:45:11
@article{eae21460-d657-4e7a-99ac-5327a6d74479,
  abstract     = {<p>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 &gt;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.</p>},
  author       = {Lapinlampi, Niina and Melin, Esbjörn and Aronica, Eleonora and Bankstahl, Jens P. and Becker, Albert and Bernard, Cristophe and Gorter, Jan A. and Gröhn, Olli and Lipsanen, Anu and Lukasiuk, Katarzyna and Löscher, Wolfgang and Paananen, Jussi and Ravizza, Teresa and Roncon, Paolo and Simonato, Michele and Vezzani, Annamaria and Kokaia, Merab and Pitkänen, Asla},
  issn         = {0920-1211},
  keyword      = {Common data element,Data management,Database,Epilepsy,Epileptogenesis},
  language     = {eng},
  month        = {01},
  pages        = {87--90},
  publisher    = {Elsevier},
  series       = {Epilepsy Research},
  title        = {Common data elements and data management : Remedy to cure underpowered preclinical studies},
  url          = {http://dx.doi.org/10.1016/j.eplepsyres.2016.11.010},
  volume       = {129},
  year         = {2017},
}