European Quality In Preclinical Data

CORDIS proporciona enlaces a los documentos públicos y las publicaciones de los proyectos de los programas marco HORIZONTE.

Los enlaces a los documentos y las publicaciones de los proyectos del Séptimo Programa Marco, así como los enlaces a algunos tipos de resultados específicos, como conjuntos de datos y «software», se obtienen dinámicamente de OpenAIRE .

Resultado final

Final press release

Final press release with summary on the general project progress and main findings will be published

First quarterly electronic bulletins online

Publication of the first quarterly electronic bulletin with information on the project progress and first results

Release of project website public and internal part, communication package (logo, flyer, social media announcement

Corporate design eg logo PPT layout flyer and public and internal part of EQIPD website set up to disseminate results to the public

First press release

The first EQIPD press release with general information focusing on the aims of the project as well as the outcomes from the first project meeting will be published

Obtain ethical approval for cross-site validation studies and ring testing

All sites involved in the animal experiments will obtain ethical approval for their experiments

Report factors identified by historical data of published data

A report will be generated that describes the experimental design factors identified from the systematic review of published academic data that affect outcomes

Report on factors that underlie the robustness and generalisability of commonly used assays

A report of the prevalence and impact of factors related to the robustness and generalisability of commonly used assays derived from the analyses of data from members of the consortium of published academic studies

Report on validated guiding principles for robustness and data quality in preclinical Neuroscience and Safety research

Based on the outcome of the harmonisation experiments a report will be generated to provide guiding principles for optimal study design and experimentation

Outcome report from cross site validation

An outcome report on stage 1 of the crosssite validation study localization stage will be generated by the sites involved in the experiments on the basis of the generated data This will involve data summaries statistical analyses and conclusions

Outcome report from harmonized testing

An outcome report on stage 2 of the crosssite validation study harmonisation stage will be generated by the sites involved in the experiments on the basis of the generated data This will involve data summaries statistical analyses and conclusions

Evaluation of existing training modules

Generation of a list of existing training modules on keyprinciples for preclinical robustness and quality including an evaluation of each module against 1 the scope of EQIPD as determined by WPs 2 3 4 5 and 6 and 2 our predefined set of User Specification Requirements USR

With input from WPs 2 and 3 develop harmonized protocols for cross validation testing

Based on input from WPs 2 and 3 the local experimental protocols will be updated in order to perform stage 2 of the crosssite validation studies eg harmonisation

Data sharing procedures beyond EQIPD

A legally valid Data Deposition agreement will be developed to ensure that data depositors have control over whether or not their data can be made public before or after the end of this consortium

Final version of the framework of key principles and criteria for guiding the design, conduct and analysis of preclinical efficacy and safety research

The framework will be reevaluated and refined with the conclusions of the prospective crosssite validation studies performed by WP23 at a second consensus meeting A final guidance will be agreed and then published A process for continuous improvement of the guidance will be agreed

Final version of quality assurance system ready for implementation in industry and academia in non-regulated research

Readytouse set of recommendations addressing the needs of research organizations of different types with the integrated risk assessment and tiered implementation tools

Outcome report from Ring testing

An outcome report on stage 3 of the crosssite validation study Ring testing stage will be generated by the sites involved in the experiments on the basis of the generated data This will involve data summaries statistical analyses and conclusions

1st Technical diagram of EQIPD-DWH

A diagram of the EQIPDDWH solution to house all different database structures required for WPs 2 and 4 with appropriate capacity and user rights

Comprehensive, engaging, selection of training materials on scientific quality, hosted on a web-based platform

A Learning Environment has been selected and installed and existing training modules or those newly developed have been collated in the Education section of this Learning Environment utilizing a collection of links to various training modules and have undergone alpha and beta testing

Structure and first incentives for electronic community enabling social learning, hosted on a web-based platform

The social learning Exposure section of the learning environment is populated and live for use including eg electronic bulletins links to existing discussion groups Facebook Twitter LinkedIn

Quality reporting module in research software (prototype)

Specifications and a working example of an information exchange protocol will be established to enable errorless and fully transparent communication between office study design assistants electronic lab journals and labbased research software

Data inclusion protocol

A transparent protocol for unbiased inclusion of experimental paradigms and data sets required for WPs 2 and 4An ontology for the description of in vivo experiments such as these including quality aspects and working alongside other groups sharing the same ambition and develop a template for the depositing of such work in open access fora such as figshare Our data will be deposited using the template devised

Publicaciones

Introduction to the EQIPD quality system

Autores: Anton Bespalov, René Bernard, Anja Gilis, Björn Gerlach, Javier Guillén, Vincent Castagné, Isabel A Lefevre, Fiona Ducrey, Lee Monk, Sandrine Bongiovanni, Bruce Altevogt, María Arroyo-Araujo, Lior Bikovski, Natasja de Bruin, Esmeralda Castaños-Vélez, Alexander Dityatev, Christoph H Emmerich, Raafat Fares, Chantelle Ferland-Beckham, Christelle Froger-Colléaux, Valerie Gailus-Durner, Sabine
Publicado en: eLife, Edición 10, 2021, ISSN 2050-084X
Editor: eLife Sciences Publications
DOI: 10.7554/elife.63294

Reproducibility of animal research in light of biological variation

Autores: Bernhard Voelkl, Naomi S. Altman, Anders Forsman, Wolfgang Forstmeier, Jessica Gurevitch, Ivana Jaric, Natasha A. Karp, Martien J. Kas, Holger Schielzeth, Tom Van de Casteele, Hanno Würbel
Publicado en: Nature Reviews Neuroscience, Edición 21/7, 2020, Página(s) 384-393, ISSN 1471-003X
Editor: Nature Publishing Group
DOI: 10.1038/s41583-020-0313-3

Choice of y-axis can mislead readers

Autores: Betül R. Erdogan, Jan Vollert, Martin C. Michel
Publicado en: Naunyn-Schmiedeberg's Arch Pharmacol, Edición 393, 2020, Página(s) 1769-1772, ISSN 1432-1912
Editor: Springer
DOI: 10.1007/s00210-020-01926-x

Protocol for a systematic review of guidelines for rigour in the design, conduct and analysis of biomedical experiments involving laboratory animals

Autores: Jan Vollert, Esther Schenker, Malcolm Macleod, Anton Bespalov, Hanno Wuerbel, Martin Christian Michel, Ulrich Dirnagl, Heidrun Potschka, Kimberley E Wever, Thomas Steckler, Bruce Altevogt, Andrew S C Rice
Publicado en: BMJ Open Science, Edición 2/1, 2018, Página(s) e000004, ISSN 2398-8703
Editor: BMJ
DOI: 10.1136/bmjos-2018-000004

European Quality in Preclinical Data (EQIPD): Een breed consortium voor het verbeteren van de kwaliteit van proefdieronderzoek.

Autores: Steckler, T., Macleod, M., Kas, M. J. H., Gilis, A., & Wever, K. E.
Publicado en: Biotechniek, Edición 57 (2), 2018, Página(s) 18-23, ISSN 0166-6207
Editor: Stichting Proefdierkundige Informatie

Commentary on the BJP 's new statistical reporting guidelines

Autores: Harvey J Motulsky, Martin C Michel
Publicado en: British Journal of Pharmacology, Edición 175/18, 2018, Página(s) 3636-3637, ISSN 0007-1188
Editor: Wiley-Blackwell
DOI: 10.1111/bph.14441

Normalization of organ bath contraction data for tissue specimen size: does one approach fit all?

Autores: Betul R. Erdogan, Irem Karaomerlioglu, Zeynep E. Yesilyurt, Nihal Ozturk, A. Elif Muderrisoglu, Martin C. Michel, Ebru Arioglu-Inan
Publicado en: Naunyn-Schmiedeberg's Archives of Pharmacology, Edición 393/2, 2020, Página(s) 243-251, ISSN 0028-1298
Editor: Springer Verlag
DOI: 10.1007/s00210-019-01727-x

Do overactive bladder symptoms and their treatment‐associated changes exhibit a normal distribution? Implications for analysis and reporting

Autores: Marjan Amiri, Sandra Murgas, Andreas Stang, Martin C. Michel
Publicado en: Neurourology and Urodynamics, Edición 39/2, 2019, Página(s) 754-761, ISSN 0733-2467
Editor: John Wiley & Sons Inc.
DOI: 10.1002/nau.24275

Be positive about negatives–recommendations for the publication of negative (or null) results

Autores: Anton Bespalov, Thomas Steckler, Phil Skolnick
Publicado en: European Neuropsychopharmacology, Edición 29/12, 2019, Página(s) 1312-1320, ISSN 0924-977X
Editor: Elsevier BV
DOI: 10.1016/j.euroneuro.2019.10.007

New Author Guidelines for Displaying Data and Reporting Data Analysis and Statistical Methods in Experimental Biology

Autores: Martin C. Michel, T.J. Murphy, Harvey J. Motulsky
Publicado en: Molecular Pharmacology, Edición 97/1, 2019, Página(s) 49-60, ISSN 0026-895X
Editor: American Society for Pharmacology and Experimental Therapeutics
DOI: 10.1124/mol.119.118927

New Author Guidelines for Displaying Data and Reporting Data Analysis and Statistical Methods in Experimental Biology

Autores: Martin C. Michel, T.J. Murphy, Harvey J. Motulsky
Publicado en: Journal of Pharmacology and Experimental Therapeutics, Edición 372/1, 2019, Página(s) 136-147, ISSN 0022-3565
Editor: American Society for Pharmacology and Experimental Therapeutics
DOI: 10.1124/jpet.119.264143

New Author Guidelines for Displaying Data and Reporting Data Analysis and Statistical Methods in Experimental Biology

Autores: Martin C. Michel, T.J. Murphy, Harvey J. Motulsky
Publicado en: Drug Metabolism and Disposition, Edición 48/1, 2019, Página(s) 64-74, ISSN 0090-9556
Editor: American Society for Pharmacology and Experimental Therapeutics
DOI: 10.1124/dmd.119.090027

Systematic review of guidelines for internal validity in the design, conduct and analysis of preclinical biomedical experiments involving laboratory animals

Autores: Jan Vollert, Esther Schenker, Malcolm Macleod, Anton Bespalov, Hanno Wuerbel, Martin Michel, Ulrich Dirnagl, Heidrun Potschka, Ann-Marie Waldron, Kimberley Wever, Thomas Steckler, Tom van de Casteele, Bruce Altevogt, Annesha Sil, Andrew S C Rice
Publicado en: BMJ Open Science, Edición 4/1, 2020, Página(s) e100046, ISSN 2398-8703
Editor: BMJ
DOI: 10.1136/bmjos-2019-100046

Sex differences in behaviour and molecular pathology in the 5XFAD model

Autores: Annesha Sil, Arina Erfani, Nicola Lamb, Rachel Copland, Gernot Riedel, Bettina Platt
Publicado en: Journal of Alzheimer's Disease (in press currently- preprint online on BioRxiv), 2021
Editor: BioRxiv
DOI: 10.1101/2021.04.29.440396

Synaptic dysfunction and memory impairments in transgenic Alzheimer’s disease models: A systematic review protocol

Autores: Kaitlyn Hair, Juan Pita Almenar, and Emily Sena, on behalf of the EQIPD WP2 study group
Publicado en: Open Science Framework, Edición N/A, 2019, Página(s) N/A
Editor: Open Science Framework

The open field test protocol in transgenic Alzheimer’s disease models: A systematic review protocol

Autores: Kaitlyn Hair and Emily Sena, on behalf of the EQIPD WP2 study group
Publicado en: Open Science Framework, Edición N/A, 2019, Página(s) N/A
Editor: Open Science Framework

Increasing the reliability of preclinical data: enabling approaches.

Autores: Isabel A. Lefevre
Publicado en: Invited speaker, 11th World Congress on Alternatives and Animal Use in the Life Science (WC11), Edición Congress postponed to August 2021, abstract published on July 6, 2020, 2020, Página(s) p 204
Editor: World Congress on Alternatives and Animal Use in the Life Sciences

Learning from Principles of Evidence-Based Medicine to Optimize Nonclinical Research Practices

Autores: Isabel A. Lefevre, Rita J. Balice-Gordon
Publicado en: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Edición 257, 2020, Página(s) 35-54, ISBN 978-3-030-33655-4
Editor: Springer International Publishing
DOI: 10.1007/164_2019_276

Building Robustness into Translational Research

Autores: Betül R. Erdogan, Martin C. Michel
Publicado en: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Edición 257, 2020, Página(s) 163-175, ISBN 978-3-030-33655-4
Editor: Springer International Publishing
DOI: 10.1007/164_2019_283

Blinding and Randomization

Autores: Anton Bespalov, Karsten Wicke, Vincent Castagné
Publicado en: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Edición 257, 2020, Página(s) 81-100, ISBN 978-3-030-33655-4
Editor: Springer International Publishing
DOI: 10.1007/164_2019_279

Good Research Practice: Lessons from Animal Care and Use

Autores: Javier Guillén, Thomas Steckler
Publicado en: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Edición 257, 2020, Página(s) 367-382, ISBN 978-3-030-33655-4
Editor: Springer International Publishing
DOI: 10.1007/164_2019_292

Quality Governance in Biomedical Research

Autores: Anja Gilis
Publicado en: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Edición 257, 2020, Página(s) 349-365, ISBN 978-3-030-33655-4
Editor: Springer International Publishing
DOI: 10.1007/164_2019_291

Minimum Information in In Vivo Research

Autores: Patrizia Voehringer, Janet R. Nicholson
Publicado en: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Edición 257, 2020, Página(s) 197-222, ISBN 978-3-030-33655-4
Editor: Springer International Publishing
DOI: 10.1007/164_2019_285

Quality in Non-GxP Research Environment

Autores: Sandrine Bongiovanni, Robert Purdue, Oleg Kornienko, René Bernard
Publicado en: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Edición 257, 2020, Página(s) 1-17, ISBN 978-3-030-33655-4
Editor: Springer International Publishing
DOI: 10.1007/164_2019_274

Guidelines and Initiatives for Good Research Practice

Autores: Patricia Kabitzke, Kristin M. Cheng, Bruce Altevogt
Publicado en: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Edición 257, 2020, Página(s) 19-34, ISBN 978-3-030-33655-4
Editor: Springer International Publishing
DOI: 10.1007/164_2019_275

General Principles of Preclinical Study Design

Autores: Wenlong Huang, Nathalie Percie du Sert, Jan Vollert, Andrew S. C. Rice
Publicado en: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Edición 257, 2020, Página(s) 55-69, ISBN 978-3-030-33655-4
Editor: Springer International Publishing
DOI: 10.1007/164_2019_277

Resolving the Tension Between Exploration and Confirmation in Preclinical Biomedical Research

Autores: Ulrich Dirnagl
Publicado en: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Edición 257, 2020, Página(s) 71-79, ISBN 978-3-030-33655-4
Editor: Springer International Publishing
DOI: 10.1007/164_2019_278

Electronic Lab Notebooks and Experimental Design Assistants

Autores: Björn Gerlach, Christopher Untucht, Alfred Stefan
Publicado en: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Edición 257, 2020, Página(s) 257-275, ISBN 978-3-030-33655-4
Editor: Springer International Publishing
DOI: 10.1007/164_2019_287

Design of Meta-Analysis Studies

Autores: Malcolm R. Macleod, Ezgi Tanriver-Ayder, Kaitlyn Hair, Emily Sena
Publicado en: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Edición 257, 2020, Página(s) 299-317, ISBN 978-3-030-33655-4
Editor: Springer International Publishing
DOI: 10.1007/164_2019_289

A European initiative to unclog pipeline for new medicines

Autores: Malcolm Macleod, Thomas Steckler
Publicado en: Nature, Edición 568/7753, 2019, Página(s) 458-458, ISSN 0028-0836
Editor: Nature Publishing Group
DOI: 10.1038/d41586-019-01293-5

Good Research Practice in Non-Clinical Pharmacology and Biomedicine

Autores: Bespalov A, Michel M, Steckler T (eds.)
Publicado en: Handbook of Experimental Pharmacology, Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Edición 257, 2020, Página(s) 1-424, ISBN 978-3-030-33656-1
Editor: Springer
DOI: 10.1007/978-3-030-33656-1

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