eLife (May 2021)
Introduction to the EQIPD quality system
- 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 M Hölter,
- Martine CJ Hofmann,
- Patricia Kabitzke,
- Martien JH Kas,
- Claudia Kurreck,
- Paul Moser,
- Malgorzata Pietraszek,
- Piotr Popik,
- Heidrun Potschka,
- Ernesto Prado Montes de Oca,
- Leonardo Restivo,
- Gernot Riedel,
- Merel Ritskes-Hoitinga,
- Janko Samardzic,
- Michael Schunn,
- Claudia Stöger,
- Vootele Voikar,
- Jan Vollert,
- Kimberley E Wever,
- Kathleen Wuyts,
- Malcolm R MacLeod,
- Ulrich Dirnagl,
- Thomas Steckler
Affiliations
- Anton Bespalov
- ORCiD
- PAASP, Heidelberg, Germany
- René Bernard
- ORCiD
- Department of Experimental Neurology, Charité Universitätsmedizin, Berlin, Germany; NeuroCure Cluster of Excellence, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; QUEST Center for Transforming Biomedical Research, Berlin Institute of Health at Charite, Berlin, Germany
- Anja Gilis
- Janssen Pharmaceutica NV, Beerse, Belgium
- Björn Gerlach
- ORCiD
- PAASP, Heidelberg, Germany
- Javier Guillén
- ORCiD
- AAALAC International, Pamplona, Spain
- Vincent Castagné
- ORCiD
- Porsolt, Le Genest-Saint-Isle, France
- Isabel A Lefevre
- ORCiD
- Rare and Neurologic Diseases Research, Sanofi, Chilly-Mazarin, France
- Fiona Ducrey
- Integrity and Global Research Practices, Sanofi, Chilly-Mazarin, France
- Lee Monk
- Research and Clinical Development Quality, UCB, Slough, United Kingdom
- Sandrine Bongiovanni
- ORCiD
- Quality Assurance, Novartis Institutes for BioMedical Research, Novartis Pharma, Basel, Switzerland
- Bruce Altevogt
- ORCiD
- Pfizer Inc., Silver Spring, United States
- María Arroyo-Araujo
- ORCiD
- Groningen Institute for Evolutionary Life Sciences, University of Groningen, Groningen, Netherlands
- Lior Bikovski
- ORCiD
- School of Behavioral Sciences, Netanya Academic College, Netanya, Israel; The Myers Neuro-Behavioral Core Facility, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
- Natasja de Bruin
- ORCiD
- Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt am Main, Germany
- Esmeralda Castaños-Vélez
- ORCiD
- Department of Experimental Neurology, Charité Universitätsmedizin, Berlin, Germany
- Alexander Dityatev
- ORCiD
- Molecular Neuroplasticity, German Center for Neurodegenerative Diseases, Magdeburg, Germany; Center for Behavioral Brain Sciences, Magdeburg, Germany; Medical Faculty, Otto-von-Guericke University, Magdeburg, Germany
- Christoph H Emmerich
- ORCiD
- PAASP, Heidelberg, Germany
- Raafat Fares
- ORCiD
- Charles River Laboratories, Safety Assessment, Lyon, France
- Chantelle Ferland-Beckham
- Cohen Veterans Bioscience, Boston, United States
- Christelle Froger-Colléaux
- ORCiD
- Porsolt, Le Genest-Saint-Isle, France
- Valerie Gailus-Durner
- German Mouse Clinic, Institute of Experimental Genetics, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg, Germany
- Sabine M Hölter
- ORCiD
- Institute of Developmental Genetics, Helmholtz Zentrum München, German Research Center for Environmental Health, and Technical University Munich, Munich, Germany
- Martine CJ Hofmann
- ORCiD
- Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt am Main, Germany
- Patricia Kabitzke
- ORCiD
- PAASP US, Ridgefield, United States; The Stanley Center for Psychiatric Research, Broad Institute of MIT and Harvard, Cambridge, United States
- Martien JH Kas
- ORCiD
- Groningen Institute for Evolutionary Life Sciences, University of Groningen, Groningen, Netherlands
- Claudia Kurreck
- Department of Experimental Neurology, Charité Universitätsmedizin, Berlin, Germany
- Paul Moser
- Cerbascience, Toulouse, France; PAASP France, Toulouse, France
- Malgorzata Pietraszek
- PAASP, Heidelberg, Germany
- Piotr Popik
- ORCiD
- Maj Institute of Pharmacology, Polish Academy of Sciences, Krakow, Poland
- Heidrun Potschka
- Institute of Pharmacology, Toxicology and Pharmacy, Ludwig-Maximilians-University, Munich, Germany
- Ernesto Prado Montes de Oca
- ORCiD
- Personalized Medicine Laboratory (LAMPER), Research Center inTechnology and Design Assistance of Jalisco State, National Council of Science andTechnology (CIATEJ-CONACYT), Mexico, Mexico; Scripps Research Translational Institute, La Jolla, United States; Integrative Structural and Computational Biology, Scripps Research, La Jolla, United States
- Leonardo Restivo
- Neuro-BAU, Department of Fundamental Neurosciences, Faculty of Biology and Medicine,University of Lausanne, Lausanne, Switzerland
- Gernot Riedel
- Institute of Medical Sciences, University of Aberdeen, Scotland, United Kingdom
- Merel Ritskes-Hoitinga
- ORCiD
- SYRCLE, Department for Health Evidence, Radboud University Medical Center, Nijmegen, Netherlands; Department for Clinical Medicine, Aarhus University, Aarhus, Denmark
- Janko Samardzic
- ORCiD
- Institute of Pharmacology, Medical Faculty, University of Belgrade, Belgrade, Serbia
- Michael Schunn
- ORCiD
- Institute of Science and Technology, Klosterneuburg, Austria
- Claudia Stöger
- ORCiD
- German Mouse Clinic, Institute of Experimental Genetics, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg, Germany
- Vootele Voikar
- ORCiD
- Neuroscience Center and Laboratory Animal Center, Helsinki Institute of Life Science, University of Helsinki, Helsinki, Finland
- Jan Vollert
- Pain Research, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, United Kingdom
- Kimberley E Wever
- ORCiD
- SYRCLE, Department for Health Evidence, Radboud University Medical Center, Nijmegen, Netherlands
- Kathleen Wuyts
- Avertim, Brussels, Belgium
- Malcolm R MacLeod
- ORCiD
- Centre for Clinical Brain Sciences, University of Edinburgh, Scotland, United Kingdom
- Ulrich Dirnagl
- ORCiD
- Department of Experimental Neurology, Charité Universitätsmedizin, Berlin, Germany; NeuroCure Cluster of Excellence, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; QUEST Center for Transforming Biomedical Research, Berlin Institute of Health at Charite, Berlin, Germany
- Thomas Steckler
- Janssen Pharmaceutica NV, Beerse, Belgium
- DOI
- https://doi.org/10.7554/eLife.63294
- Journal volume & issue
-
Vol. 10
Abstract
While high risk of failure is an inherent part of developing innovative therapies, it can be reduced by adherence to evidence-based rigorous research practices. Supported through the European Union’s Innovative Medicines Initiative, the EQIPD consortium has developed a novel preclinical research quality system that can be applied in both public and private sectors and is free for anyone to use. The EQIPD Quality System was designed to be suited to boost innovation by ensuring the generation of robust and reliable preclinical data while being lean, effective and not becoming a burden that could negatively impact the freedom to explore scientific questions. EQIPD defines research quality as the extent to which research data are fit for their intended use. Fitness, in this context, is defined by the stakeholders, who are the scientists directly involved in the research, but also their funders, sponsors, publishers, research tool manufacturers, and collaboration partners such as peers in a multi-site research project. The essence of the EQIPD Quality System is the set of 18 core requirements that can be addressed flexibly, according to user-specific needs and following a user-defined trajectory. The EQIPD Quality System proposes guidance on expectations for quality-related measures, defines criteria for adequate processes (i.e. performance standards) and provides examples of how such measures can be developed and implemented. However, it does not prescribe any pre-determined solutions. EQIPD has also developed tools (for optional use) to support users in implementing the system and assessment services for those research units that successfully implement the quality system and seek formal accreditation. Building upon the feedback from users and continuous improvement, a sustainable EQIPD Quality System will ultimately serve the entire community of scientists conducting non-regulated preclinical research, by helping them generate reliable data that are fit for their intended use.
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