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

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

doi:10.1016/j.eplepsyres.2016.11.010

Cited by 36 publications

(37 citation statements)

References 14 publications

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“…A Core CRF and CDE document has already been released by the AES/ILAE, which comprises the most critical information to be applied to all preclinical studies for epilepsy (e.g., physiology, behavior, electroencephalography [EEG] analysis, and pharmacology). This Core document includes valuable information pertaining to animal diet, strain, age, gender, and so on . The present manuscript now details accompanying CDEs and CRFs that extend that prior report to include information determined necessary for sound pharmacologic evaluations in preclinical models of seizure and epilepsy.…”

Section: Rationale For Model Selectionmentioning

confidence: 95%

A companion to the preclinical common data elements for pharmacologic studies in animal models of seizures and epilepsy. A Report of the TASK3 Pharmacology Working Group of the ILAE/AES Joint Translational Task Force

et al. 2018

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SummaryPreclinical pharmacology studies in animal models of seizures and epilepsy have provided a platform to identify more than 20 antiseizure drugs in recent decades. To minimize variability in lab‐to‐lab studies and to harmonize approaches to data collection and reporting methodology in pharmacologic evaluations of the next generation of therapies, we present common data elements (CDEs), case report forms (CRFs), and this companion manuscript to help with the implementation of methods for studies in established preclinical seizure and epilepsy models in adult rodents. The development of and advocacy for CDEs in preclinical research has been encouraged previously by both clinical and preclinical groups. It is anticipated that adoption and implementation of these CDEs in preclinical studies may help standardize approaches to minimize variability and increase the reproducibility of preclinical studies. Moreover, they may provide a methodologic framework for pharmacology studies in atypical animal models or models in development, which may ultimately promote novel therapy development. In the present document, we refer selectively to animal models that have a long history of preclinical use, and in some cases, are clinically validated.

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Section: Rationale For Model Selectionmentioning

confidence: 95%

A companion to the preclinical common data elements for pharmacologic studies in animal models of seizures and epilepsy. A Report of the TASK3 Pharmacology Working Group of the ILAE/AES Joint Translational Task Force

et al. 2018

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“…The ultimate hope is indeed to try to develop biomarkers and to find new treatments for epilepsy. Of note, the EPITARGET consortium has developed CDEs for other modules and has started to use a Research Electronic Data Capture (REDCap) database, in which actual data from preclinical studies can be registered online . Finally, to be able to develop these more standardized approaches, funds should be made available to publish and use interactive forms, maintain databases, and to take care that unpublished data are protected.…”

Section: Discussionmentioning

confidence: 99%

“…The forms are constructed in analogy to previous preclinical CDEs by the National Institute of Neurological Disorders and Stroke (NINDS) for traumatic brain injury research . CDEs generated by the EPITARGET consortium (Targets and Biomarkers for Antiepileptogenesis) served as useful templates for our TASK3 Physiology working group . The proposed recommendations originate mostly from previously published methods used for rodent physiology research.…”

Section: Methodsmentioning

confidence: 99%

A companion to the preclinical common data elements for physiologic data in rodent epilepsy models. A report of the TASK3 Physiology Working Group of the ILAE/AES Joint Translational Task Force

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SummaryThe International League Against Epilepsy/American Epilepsy Society (ILAE/AES) Joint Translational Task Force created the TASK3 working groups to create common data elements (CDEs) for various aspects of preclinical epilepsy research studies, which could help improve standardization of experimental designs. This article concerns the parameters that can be measured to assess the physiologic condition of the animals that are used to study rodent models of epilepsy. Here we discuss CDEs for physiologic parameters measured in adult rats and mice such as general health status, temperature, cardiac and respiratory function, and blood constituents. We provide detailed CDE tables and case report forms (CRFs), and with this companion manuscript we discuss the monitoring of different aspects of physiology of the animals. The CDEs, CRFs, and companion paper are available to all researchers, and their use will benefit the harmonization and comparability of translational preclinical epilepsy research. The ultimate hope is to facilitate the development of biomarkers and new treatments for epilepsy.

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“…The need for standardization of preclinical studies was recognized in the European Union 7th Framework–funded project Targets and Biomarkers for Antiepileptogenesis (EPITARGET), a consortium of 18 partners in nine European Countries, 12 of which conduct preclinical studies. This led to the design of the first available common data elements (CDEs) for preclinical studies on epilepsy to help investigators to systematically collect, analyze, standardize, and share preclinical epilepsy data . These CDEs and case report forms can be downloaded from the EPITARGET Web page (http://www.epitarget.eu) and are highly recommended.…”

Section: Documentationmentioning

confidence: 99%

“…Standardized sampling protocols have been recommended for human studies, which can be easily adopted in different laboratories in multicenter trials (e.g., https://intbir.nih.gov/sites/all/themes/nivea//NINDS_Repository_Biomarkers_Discovery_Samples_Resource_Manual.pdf). The need for powered, harmonized studies has been well recognized also in experimental modeling of human diseases, including biomarker discovery in epilepsy . Here, our objectives were to (1) review the existing literature of plasma sampling protocols in rat and (2) test and compare different plasma sampling protocols, to identify the one that best suits the needs of the search of miRNA biomarkers for epileptogenesis.…”

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confidence: 99%

Standardization procedure for plasma biomarker analysis in rat models of epileptogenesis: Focus on circulating microRNAs

et al. 2017

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The World Health Organization estimates that globally 2.4 million people are diagnosed with epilepsy each year. In nearly 30% of these cases, epilepsy cannot be properly controlled by antiepileptic drugs. More importantly, treatments to prevent or modify epileptogenesis do not exist. Therefore, novel therapies are urgently needed. In this respect, it is important to identify which patients will develop epilepsy and which individually tailored treatment is needed. However, currently, we have no tools to identify the patients at risk, and diagnosis of epileptogenesis remains as a major unmet medical need, which relates to lack of diagnostic biomarkers for epileptogenesis. As the epileptogenic process in humans is typically slow, the use of animal models is justified to speed up biomarker discovery. We aim to summarize recommendations for molecular biomarker research and propose a standardized procedure for biomarker discovery in rat models of epileptogenesis. The potential of many phylogenetically conserved circulating noncoding small RNAs, including microRNAs (miRNAs), as biomarkers has been explored in various brain diseases, including epilepsy. Recent studies show the feasibility of detecting miRNAs in blood in both experimental models and human epilepsy. However, the analysis of circulating miRNAs in rodent models is challenging, which relates both to the lack of standardized sampling protocols and to analysis of miRNAs. We will discuss the issues critical for preclinical plasma biomarker discovery, such as documentation, blood and brain tissue sampling and collection, plasma separation and storage, RNA extraction, quality control, and RNA detection. We propose a protocol for standardization of procedures for discovery of circulating miRNA biomarkers in rat models of epileptogenesis. Ultimately, we hope that the preclinical standardization will facilitate clinical biomarker discovery for epileptogenesis in man.

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

Cited by 36 publications

References 14 publications

A companion to the preclinical common data elements for pharmacologic studies in animal models of seizures and epilepsy. A Report of the TASK3 Pharmacology Working Group of the ILAE/AES Joint Translational Task Force

A companion to the preclinical common data elements for pharmacologic studies in animal models of seizures and epilepsy. A Report of the TASK3 Pharmacology Working Group of the ILAE/AES Joint Translational Task Force

A companion to the preclinical common data elements for physiologic data in rodent epilepsy models. A report of the TASK3 Physiology Working Group of the ILAE/AES Joint Translational Task Force

Standardization procedure for plasma biomarker analysis in rat models of epileptogenesis: Focus on circulating microRNAs

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