A companion to the preclinical common data elements for rigor, reproducibility and transparency in basic and translational epilepsy research. A report of the TASK3-WG1A: Pharmacology Working Group of the ILAE/AES Joint Translational Task Force

Rigorous and transparent procedures in preclinical epilepsy research studies are important to permit assessing the reproducibility of their findings and derisk their translation into the clinic. The General Pharmacology Working Group of the ILAE/AES Task Force (TASK3-WG1A) developed common data elements (CDEs) addressing rigor and transparency and organized the CDEs into a case report form (CRF) to provide guidance on study planning, conduct, analysis, and reporting. CDEs specifying the type of study, use of inclusion–exclusion criteria, quantitative methods, randomization, blinding, and masking were developed and defined. This companion paper provides additional information and interpretation on the use of the rigor and transparency CDEs to assist preclinical investigators. Adoption of these CDEs and CRF will enhance data quality and transparent reporting to improve the reuse of preclinical data sets and the successful translation of preclinical epilepsy research. The materials provided in the form of CDEs, CRF, and this companion paper can be used in the research community for training purposes and to promote more rigorous conduct and transparent reporting of basic and translational epilepsy research. Plain Language Summary: The purpose of the Common Data Elements described in this companion paper is to improve the rigor, reproducibility, and transparency of basic and translational epilepsy research studies. Enhancing these important elements of preclinical epilepsy research will facilitate data sharing and comparisons between research laboratories and potentially the reliability of translating preclinical research findings to clinical studies that reduce the burden of disease for individuals with epilepsy.