Introduction to the EQIPD quality system

  1. Anton Bespalov  Is a corresponding author
  2. René Bernard
  3. Anja Gilis
  4. Björn Gerlach
  5. Javier Guillen
  6. Vincent Castagne
  7. Isabel Lefevre
  8. Fiona Ducrey
  9. Lee Monk
  10. Sandrine Bongiovanni
  11. Bruce Altevogt
  12. Maria Arroyo Araujo
  13. Lior Bikovski
  14. Natasja de Bruin
  15. Esmeralda Castaños-Vélez
  16. Alexander Dityatev
  17. Christoph H Emmerich
  18. Raafat Fares
  19. Chantelle Ferland-Beckham
  20. Christelle Froger-Colléaux
  21. Valerie Gailus-Durner
  22. Sabine M Hölter
  23. Martine CJ Hofmann
  24. Patricia Kabitzke
  25. Martien J H Kas
  26. Claudia Kurreck
  27. Paul Moser
  28. Malgorzata Pietraszek
  29. Piotr Popik
  30. Heidrun Potschka
  31. Ernesto Prado Montes de Oca
  32. Leonardo Restivo
  33. Gernot Riedel
  34. Merel Ritskes-Hoitinga
  35. Janko Samardzic
  36. Michael Schunn
  37. Claudia Stöger
  38. Vootele Voikar
  39. Jan Vollert
  40. Kimberley E Wever
  41. Kathleen Wuyts
  42. Malcolm R MacLeod
  43. Ulrich Dirnagl
  44. Thomas Steckler
  1. PAASP, Germany
  2. Charité Universitätsmedizin, Germany
  3. Janssen Pharmaceutica NV, Belgium
  4. PAASP GmbH, Germany
  5. AAALAC International, Spain
  6. Porsolt, France
  7. Sanofi, France
  8. UCB, United Kingdom
  9. Novartis pharma, Switzerland
  10. Pfizer, United States
  11. University of Groningen, Netherlands
  12. Tel Aviv University, Israel
  13. Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Germany
  14. Deutsches Zentrum für Neurodegenerative Erkrankungen e.V. (DZNE), Germany
  15. Charles River Laboratories, France
  16. Cohen Veterans Bioscience, United States
  17. German Mouse Clinic, Germany
  18. Helmholtz Zentrum München, Germany
  19. Broad Institute of MIT & Harvard, United States
  20. PAASP, France
  21. Polish Academy of Sciences, Poland
  22. Institute of Pharmacology, Toxicology, and Pharmacy, Germany
  23. National Council of Science and Technology, Mexico
  24. The University of Lausanne, Switzerland
  25. University of Aberdeen, United Kingdom
  26. Radboud University Medical Center, Netherlands
  27. University of Belgrade, Serbia
  28. Institute of Science and Technology, Austria
  29. University of Helsinki, Finland
  30. Imperial College London, United Kingdom
  31. Avertim, Belgium
  32. University of Edinburgh, United Kingdom

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. Numerous analyses conducted to date have clearly identified measures that need to be taken to improve research rigor. 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.

Data availability

We have not generated any data

Article and author information

Author details

  1. Anton Bespalov

    none, PAASP, Heidelberg, Germany
    For correspondence
    anton.bespalov@paasp.net
    Competing interests
    Anton Bespalov, AB is an employee and/or shareholder at PAASP GmbH, PAASP US LLC, Exciva GmbH, Synventa LLC, Ritec Pharma.
    ORCID icon "This ORCID iD identifies the author of this article:" 0000-0003-3730-1395
  2. René Bernard

    Charité Universitätsmedizin, Berlin, Germany
    Competing interests
    No competing interests declared.
    ORCID icon "This ORCID iD identifies the author of this article:" 0000-0003-3265-2372
  3. Anja Gilis

    Janssen Pharmaceutica NV, Janssen Pharmaceutica NV, Beerse, Belgium
    Competing interests
    Anja Gilis, AG are employees of Janssen / Johnson & Johnson and shareholders at Johnson & Johnson.
  4. Björn Gerlach

    Operational, PAASP GmbH, Heidelberg, Germany
    Competing interests
    Björn Gerlach, BG and CE are employees and shareholders at PAASP GmbH..
    ORCID icon "This ORCID iD identifies the author of this article:" 0000-0002-4900-6302
  5. Javier Guillen

    AAALAC International, AAALAC International, Pamplona, Spain
    Competing interests
    Javier Guillen, JG is an employee of AAALAC International that is an EQIPD Associated Collaborator..
    ORCID icon "This ORCID iD identifies the author of this article:" 0000-0001-8188-7587
  6. Vincent Castagne

    Porsolt, Porsolt, Le Genest-Saint-Isle, France
    Competing interests
    Vincent Castagne, VC and CFC are employees of Porsolt..
  7. Isabel Lefevre

    Rare and Neurologic Diseases Research, Sanofi, Chilly-Mazarin, France
    Competing interests
    Isabel Lefevre, IAL and FD are employees of Sanofi..
  8. Fiona Ducrey

    Integrity and Global Research Practices, Sanofi, Chilly-Mazarin, France
    Competing interests
    Fiona Ducrey, IAL and FD are employees of Sanofi..
  9. Lee Monk

    Research and Clinical Development Quality, UCB, Slough, United Kingdom
    Competing interests
    Lee Monk, LM is an employee and shareholder of UCB..
  10. Sandrine Bongiovanni

    Quality Assurance, Novartis Institutes for BioMedical Research, Novartis pharma, Basel, Switzerland
    Competing interests
    Sandrine Bongiovanni, SB is an employee of Novartis Pharma..
    ORCID icon "This ORCID iD identifies the author of this article:" 0000-0002-8655-6514
  11. Bruce Altevogt

    Pfizer, Pfizer, Silver Spring, United States
    Competing interests
    Bruce Altevogt, BA is an employee and shareholder of Pfizer. The views and opinions expressed in this article are those of the individual author and should not be attributed to Pfizer, its directors, officers, employees, affiliates, or any organization with which the author is employed or affiliated..
  12. Maria Arroyo Araujo

    Groningen Institute for Evolutionary Life Sciences, University of Groningen, Groningen, Netherlands
    Competing interests
    No competing interests declared.
  13. Lior Bikovski

    The Myers Neuro-Behavioral Core Facility, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
    Competing interests
    No competing interests declared.
  14. Natasja de Bruin

    Branch for Translational Medicine and Pharmacology TMP, Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Frankfurt, Germany
    Competing interests
    No competing interests declared.
    ORCID icon "This ORCID iD identifies the author of this article:" 0000-0002-2456-2783
  15. Esmeralda Castaños-Vélez

    Charité Universitätsmedizin, Berlin, Germany
    Competing interests
    No competing interests declared.
    ORCID icon "This ORCID iD identifies the author of this article:" 0000-0002-2670-1118
  16. Alexander Dityatev

    Molecular Neuroplasticity Group, Deutsches Zentrum für Neurodegenerative Erkrankungen e.V. (DZNE), Magdeburg, Germany
    Competing interests
    No competing interests declared.
    ORCID icon "This ORCID iD identifies the author of this article:" 0000-0002-0472-0553
  17. Christoph H Emmerich

    PAASP, PAASP, Heidelberg, Germany
    Competing interests
    Christoph H Emmerich, BG and CE are employees and shareholders at PAASP GmbH..
  18. Raafat Fares

    Safety Assessment, Charles River Laboratories, Lyon, France
    Competing interests
    No competing interests declared.
  19. Chantelle Ferland-Beckham

    Cohen Veterans Bioscience, Cohen Veterans Bioscience, Boston, United States
    Competing interests
    Chantelle Ferland-Beckham, AB, BA, NdB, UD, CFB, PK, MK, MM, PM, PP, GR, JS, and TS are members of the Preclinical Data Forum (co-chairs - AB and TS), a network financially and organizationally supported by ECNP and Cohen Veterans Bioscience..
  20. Christelle Froger-Colléaux

    Porsolt, Porsolt, Le Genest-Saint-Isle, France
    Competing interests
    Christelle Froger-Colléaux, VC and CFC are employees of Porsolt..
  21. Valerie Gailus-Durner

    Institute of Experimental Genetics, German Mouse Clinic, München, Germany
    Competing interests
    No competing interests declared.
  22. Sabine M Hölter

    Institute of Developmental Genetics, Helmholtz Zentrum München, Neuherberg, Germany
    Competing interests
    No competing interests declared.
    ORCID icon "This ORCID iD identifies the author of this article:" 0000-0003-4878-5241
  23. Martine CJ Hofmann

    Branch for Translational Medicine and Pharmacology TMP, Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Frankfurt, Germany
    Competing interests
    No competing interests declared.
  24. Patricia Kabitzke

    The Stanley Center for Psychiatric Research, Broad Institute of MIT & Harvard, Cambridge, United States
    Competing interests
    Patricia Kabitzke, PK is an employee and shareholder at PAASP US LLC..
  25. Martien J H Kas

    Groningen Institute for Evolutionary Life Sciences, University of Groningen, Groningen, Netherlands
    Competing interests
    No competing interests declared.
    ORCID icon "This ORCID iD identifies the author of this article:" 0000-0002-4471-8618
  26. Claudia Kurreck

    Charité Universitätsmedizin, Berlin, Germany
    Competing interests
    Claudia Kurreck, UD and CK receive funding from Volkswagen Foundation.
  27. Paul Moser

    PAASP, PAASP, Toulouse, France
    Competing interests
    Paul Moser, PM is owner of Cerbascience Consulting.
  28. Malgorzata Pietraszek

    PAASP, PAASP, Heidelberg, Germany
    Competing interests
    No competing interests declared.
  29. Piotr Popik

    Maj Institute of Pharmacology, Polish Academy of Sciences, Krakow, Poland
    Competing interests
    No competing interests declared.
  30. Heidrun Potschka

    Department of veterinary medicine of the Ludwig-Maximilians-University, Institute of Pharmacology, Toxicology, and Pharmacy, Munich, Germany
    Competing interests
    Heidrun Potschka, HP has received during the last three years consulting and speaking fees and/or funding for collaborative projects from Bayer, Roche, Zogenix, and Eisai..
  31. Ernesto Prado Montes de Oca

    Research Center in Technology and Design Assistance of Jalisco State, National Council of Science and Technology, Guadalajara, Mexico
    Competing interests
    No competing interests declared.
    ORCID icon "This ORCID iD identifies the author of this article:" 0000-0002-0617-4752
  32. Leonardo Restivo

    Fundamental Neuroscience, The University of Lausanne, Lausanne, Switzerland
    Competing interests
    No competing interests declared.
  33. Gernot Riedel

    Institute of Medical Sciences, University of Aberdeen, Aberdeen, United Kingdom
    Competing interests
    No competing interests declared.
  34. Merel Ritskes-Hoitinga

    Radboud University Medical Center, Nijmegen, Netherlands
    Competing interests
    No competing interests declared.
  35. Janko Samardzic

    Institute of Pharmacology, Medical Faculty, University of Belgrade, Belgrade, Serbia
    Competing interests
    No competing interests declared.
    ORCID icon "This ORCID iD identifies the author of this article:" 0000-0002-8464-4924
  36. Michael Schunn

    Institute of Science and Technology, Institute of Science and Technology, Klosterneuburg, Austria
    Competing interests
    No competing interests declared.
  37. Claudia Stöger

    German Mouse Clinic, Institute of Experimental Genetics, Helmholtz Zentrum München, Munich, Germany
    Competing interests
    No competing interests declared.
  38. Vootele Voikar

    Neuroscience Center and Laboratory Animal Center, Helsinki Institute of Life Science, University of Helsinki, Helsinki, Finland
    Competing interests
    No competing interests declared.
  39. Jan Vollert

    Pain Research, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, United Kingdom
    Competing interests
    No competing interests declared.
  40. Kimberley E Wever

    Radboud University Medical Center, Nijmegen, Netherlands
    Competing interests
    No competing interests declared.
    ORCID icon "This ORCID iD identifies the author of this article:" 0000-0003-3635-3660
  41. Kathleen Wuyts

    Avertim, Avertim, Brussels, Belgium
    Competing interests
    Kathleen Wuyts, KW is a consultant of Avertim, Brussels, Belgium, support for this contribution was funded by Janssen Pharmaceutica NV..
  42. Malcolm R MacLeod

    Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, United Kingdom
    Competing interests
    Malcolm R MacLeod, MM, UD and TS are members of the Advisory Board at PAASP. MM, UD and TS are members of the ARRIVE guidelines working group..
    ORCID icon "This ORCID iD identifies the author of this article:" 0000-0001-9187-9839
  43. Ulrich Dirnagl

    Charité Universitätsmedizin, Berlin, Germany
    Competing interests
    Ulrich Dirnagl, UD and CK receive funding from Volkswagen Foundation.MM, UD and TS are members of the Advisory Board at PAASP. MM, UD and TS are members of the ARRIVE guidelines working group..
    ORCID icon "This ORCID iD identifies the author of this article:" 0000-0003-0755-6119
  44. Thomas Steckler

    Janssen Pharmaceutica NV, Janssen Pharmaceutica NV, Beerse, Belgium
    Competing interests
    Thomas Steckler, MM, UD and TS are members of the Advisory Board at PAASP. MM, UD and TS are members of the ARRIVE guidelines working group.TS is an AAALAC ad-hoc specialist. TS and AG are employees of Janssen / Johnson & Johnson and shareholders at Johnson & Johnson..

Funding

Innovative Medicines Initiative (777364)

  • Malcolm R MacLeod

The funders had no role in study design, data collection and interpretation, or the decision to submit the work for publication.

Reviewing Editor

  1. Mone Zaidi, Icahn School of Medicine at Mount Sinai, United States

Version history

  1. Received: September 21, 2020
  2. Accepted: May 20, 2021
  3. Accepted Manuscript published: May 24, 2021 (version 1)
  4. Version of Record published: June 7, 2021 (version 2)

Copyright

© 2021, Bespalov et al.

This article is distributed under the terms of the Creative Commons Attribution License permitting unrestricted use and redistribution provided that the original author and source are credited.

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  1. Anton Bespalov
  2. René Bernard
  3. Anja Gilis
  4. Björn Gerlach
  5. Javier Guillen
  6. Vincent Castagne
  7. Isabel Lefevre
  8. Fiona Ducrey
  9. Lee Monk
  10. Sandrine Bongiovanni
  11. Bruce Altevogt
  12. Maria Arroyo Araujo
  13. Lior Bikovski
  14. Natasja de Bruin
  15. Esmeralda Castaños-Vélez
  16. Alexander Dityatev
  17. Christoph H Emmerich
  18. Raafat Fares
  19. Chantelle Ferland-Beckham
  20. Christelle Froger-Colléaux
  21. Valerie Gailus-Durner
  22. Sabine M Hölter
  23. Martine CJ Hofmann
  24. Patricia Kabitzke
  25. Martien J H Kas
  26. Claudia Kurreck
  27. Paul Moser
  28. Malgorzata Pietraszek
  29. Piotr Popik
  30. Heidrun Potschka
  31. Ernesto Prado Montes de Oca
  32. Leonardo Restivo
  33. Gernot Riedel
  34. Merel Ritskes-Hoitinga
  35. Janko Samardzic
  36. Michael Schunn
  37. Claudia Stöger
  38. Vootele Voikar
  39. Jan Vollert
  40. Kimberley E Wever
  41. Kathleen Wuyts
  42. Malcolm R MacLeod
  43. Ulrich Dirnagl
  44. Thomas Steckler
(2021)
Introduction to the EQIPD quality system
eLife 10:e63294.
https://doi.org/10.7554/eLife.63294

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https://doi.org/10.7554/eLife.63294

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