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

Research output: Contribution to journalArticlepeer-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 languageEnglish
Pages (from-to)87-90
Number of pages4
JournalEpilepsy Research
Volume129
DOIs
Publication statusPublished - Jan 1 2017

Keywords

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

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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