European Quality In Preclinical Data

Projektinformationen

EQIPD

ID Finanzhilfevereinbarung: 777364

DOI

10.3030/777364

Projekt abgeschlossen

EK-Unterschriftsdatum 18 August 2017

Startdatum 1 Oktober 2017

Enddatum 30 September 2021

Finanziert unter

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Gesamtkosten

€ 9 360 691,93

EU-Beitrag

€ 4 495 523,00

Koordiniert durch

THE UNIVERSITY OF EDINBURGH
United Kingdom

CORDIS bietet Links zu öffentlichen Ergebnissen und Veröffentlichungen von HORIZONT-Projekten.

Links zu Ergebnissen und Veröffentlichungen von RP7-Projekten sowie Links zu einigen Typen spezifischer Ergebnisse wie Datensätzen und Software werden dynamisch von OpenAIRE abgerufen.

Leistungen

Websites, patent fillings, videos etc. (4)

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

Documents, reports (12)

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

Other (3)

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

Demonstrators, pilots, prototypes (1)

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

Open Research Data Pilot (1)

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

Veröffentlichungen

Peer reviewed articles (13)

Introduction to the EQIPD quality system

Autoren: 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
Veröffentlicht in: eLife, Ausgabe 10, 2021, ISSN 2050-084X
Herausgeber: eLife Sciences Publications
DOI: 10.7554/elife.63294

Reproducibility of animal research in light of biological variation

Autoren: 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
Veröffentlicht in: Nature Reviews Neuroscience, Ausgabe 21/7, 2020, Seite(n) 384-393, ISSN 1471-003X
Herausgeber: Nature Publishing Group
DOI: 10.1038/s41583-020-0313-3

Choice of y-axis can mislead readers

Autoren: Betül R. Erdogan, Jan Vollert, Martin C. Michel
Veröffentlicht in: Naunyn-Schmiedeberg's Arch Pharmacol, Ausgabe 393, 2020, Seite(n) 1769-1772, ISSN 1432-1912
Herausgeber: 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

Autoren: 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
Veröffentlicht in: BMJ Open Science, Ausgabe 2/1, 2018, Seite(n) e000004, ISSN 2398-8703
Herausgeber: BMJ
DOI: 10.1136/bmjos-2018-000004

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

Autoren: Steckler, T., Macleod, M., Kas, M. J. H., Gilis, A., & Wever, K. E.
Veröffentlicht in: Biotechniek, Ausgabe 57 (2), 2018, Seite(n) 18-23, ISSN 0166-6207
Herausgeber: Stichting Proefdierkundige Informatie

Commentary on the BJP 's new statistical reporting guidelines

Autoren: Harvey J Motulsky, Martin C Michel
Veröffentlicht in: British Journal of Pharmacology, Ausgabe 175/18, 2018, Seite(n) 3636-3637, ISSN 0007-1188
Herausgeber: Wiley-Blackwell
DOI: 10.1111/bph.14441

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

Autoren: Betul R. Erdogan, Irem Karaomerlioglu, Zeynep E. Yesilyurt, Nihal Ozturk, A. Elif Muderrisoglu, Martin C. Michel, Ebru Arioglu-Inan
Veröffentlicht in: Naunyn-Schmiedeberg's Archives of Pharmacology, Ausgabe 393/2, 2020, Seite(n) 243-251, ISSN 0028-1298
Herausgeber: 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

Autoren: Marjan Amiri, Sandra Murgas, Andreas Stang, Martin C. Michel
Veröffentlicht in: Neurourology and Urodynamics, Ausgabe 39/2, 2019, Seite(n) 754-761, ISSN 0733-2467
Herausgeber: John Wiley & Sons Inc.
DOI: 10.1002/nau.24275

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

Autoren: Anton Bespalov, Thomas Steckler, Phil Skolnick
Veröffentlicht in: European Neuropsychopharmacology, Ausgabe 29/12, 2019, Seite(n) 1312-1320, ISSN 0924-977X
Herausgeber: 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

Autoren: Martin C. Michel, T.J. Murphy, Harvey J. Motulsky
Veröffentlicht in: Molecular Pharmacology, Ausgabe 97/1, 2019, Seite(n) 49-60, ISSN 0026-895X
Herausgeber: 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

Autoren: Martin C. Michel, T.J. Murphy, Harvey J. Motulsky
Veröffentlicht in: Journal of Pharmacology and Experimental Therapeutics, Ausgabe 372/1, 2019, Seite(n) 136-147, ISSN 0022-3565
Herausgeber: 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

Autoren: Martin C. Michel, T.J. Murphy, Harvey J. Motulsky
Veröffentlicht in: Drug Metabolism and Disposition, Ausgabe 48/1, 2019, Seite(n) 64-74, ISSN 0090-9556
Herausgeber: 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

Autoren: 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
Veröffentlicht in: BMJ Open Science, Ausgabe 4/1, 2020, Seite(n) e100046, ISSN 2398-8703
Herausgeber: BMJ
DOI: 10.1136/bmjos-2019-100046

Other (3)

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

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

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

Autoren: Kaitlyn Hair, Juan Pita Almenar, and Emily Sena, on behalf of the EQIPD WP2 study group
Veröffentlicht in: Open Science Framework, Ausgabe N/A, 2019, Seite(n) N/A
Herausgeber: Open Science Framework

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

Autoren: Kaitlyn Hair and Emily Sena, on behalf of the EQIPD WP2 study group
Veröffentlicht in: Open Science Framework, Ausgabe N/A, 2019, Seite(n) N/A
Herausgeber: Open Science Framework

Conference proceedings (1)

Increasing the reliability of preclinical data: enabling approaches.

Autoren: Isabel A. Lefevre
Veröffentlicht in: Invited speaker, 11th World Congress on Alternatives and Animal Use in the Life Science (WC11), Ausgabe Congress postponed to August 2021, abstract published on July 6, 2020, 2020, Seite(n) p 204
Herausgeber: World Congress on Alternatives and Animal Use in the Life Sciences

Book chapters (12)

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

Autoren: Isabel A. Lefevre, Rita J. Balice-Gordon
Veröffentlicht in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Ausgabe 257, 2020, Seite(n) 35-54, ISBN 978-3-030-33655-4
Herausgeber: Springer International Publishing
DOI: 10.1007/164_2019_276

Building Robustness into Translational Research

Autoren: Betül R. Erdogan, Martin C. Michel
Veröffentlicht in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Ausgabe 257, 2020, Seite(n) 163-175, ISBN 978-3-030-33655-4
Herausgeber: Springer International Publishing
DOI: 10.1007/164_2019_283

Blinding and Randomization

Autoren: Anton Bespalov, Karsten Wicke, Vincent Castagné
Veröffentlicht in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Ausgabe 257, 2020, Seite(n) 81-100, ISBN 978-3-030-33655-4
Herausgeber: Springer International Publishing
DOI: 10.1007/164_2019_279

Good Research Practice: Lessons from Animal Care and Use

Autoren: Javier Guillén, Thomas Steckler
Veröffentlicht in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Ausgabe 257, 2020, Seite(n) 367-382, ISBN 978-3-030-33655-4
Herausgeber: Springer International Publishing
DOI: 10.1007/164_2019_292

Quality Governance in Biomedical Research

Autoren: Anja Gilis
Veröffentlicht in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Ausgabe 257, 2020, Seite(n) 349-365, ISBN 978-3-030-33655-4
Herausgeber: Springer International Publishing
DOI: 10.1007/164_2019_291

Minimum Information in In Vivo Research

Autoren: Patrizia Voehringer, Janet R. Nicholson
Veröffentlicht in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Ausgabe 257, 2020, Seite(n) 197-222, ISBN 978-3-030-33655-4
Herausgeber: Springer International Publishing
DOI: 10.1007/164_2019_285

Quality in Non-GxP Research Environment

Autoren: Sandrine Bongiovanni, Robert Purdue, Oleg Kornienko, René Bernard
Veröffentlicht in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Ausgabe 257, 2020, Seite(n) 1-17, ISBN 978-3-030-33655-4
Herausgeber: Springer International Publishing
DOI: 10.1007/164_2019_274

Guidelines and Initiatives for Good Research Practice

Autoren: Patricia Kabitzke, Kristin M. Cheng, Bruce Altevogt
Veröffentlicht in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Ausgabe 257, 2020, Seite(n) 19-34, ISBN 978-3-030-33655-4
Herausgeber: Springer International Publishing
DOI: 10.1007/164_2019_275

General Principles of Preclinical Study Design

Autoren: Wenlong Huang, Nathalie Percie du Sert, Jan Vollert, Andrew S. C. Rice
Veröffentlicht in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Ausgabe 257, 2020, Seite(n) 55-69, ISBN 978-3-030-33655-4
Herausgeber: Springer International Publishing
DOI: 10.1007/164_2019_277

Resolving the Tension Between Exploration and Confirmation in Preclinical Biomedical Research

Autoren: Ulrich Dirnagl
Veröffentlicht in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Ausgabe 257, 2020, Seite(n) 71-79, ISBN 978-3-030-33655-4
Herausgeber: Springer International Publishing
DOI: 10.1007/164_2019_278

Electronic Lab Notebooks and Experimental Design Assistants

Autoren: Björn Gerlach, Christopher Untucht, Alfred Stefan
Veröffentlicht in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Ausgabe 257, 2020, Seite(n) 257-275, ISBN 978-3-030-33655-4
Herausgeber: Springer International Publishing
DOI: 10.1007/164_2019_287

Design of Meta-Analysis Studies

Autoren: Malcolm R. Macleod, Ezgi Tanriver-Ayder, Kaitlyn Hair, Emily Sena
Veröffentlicht in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Ausgabe 257, 2020, Seite(n) 299-317, ISBN 978-3-030-33655-4
Herausgeber: Springer International Publishing
DOI: 10.1007/164_2019_289

Non-peer reviewed articles (1)

A European initiative to unclog pipeline for new medicines

Autoren: Malcolm Macleod, Thomas Steckler
Veröffentlicht in: Nature, Ausgabe 568/7753, 2019, Seite(n) 458-458, ISSN 0028-0836
Herausgeber: Nature Publishing Group
DOI: 10.1038/d41586-019-01293-5

Monographic books (1)

Good Research Practice in Non-Clinical Pharmacology and Biomedicine

Autoren: Bespalov A, Michel M, Steckler T (eds.)
Veröffentlicht in: Handbook of Experimental Pharmacology, Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Ausgabe 257, 2020, Seite(n) 1-424, ISBN 978-3-030-33656-1
Herausgeber: Springer
DOI: 10.1007/978-3-030-33656-1