Introduction to the EQIPD quality system-Reference-Cited by-同舟云学术

Introduction to the EQIPD quality system

Published:2021-05-24 Issue: Volume:10 Page:
ISSN:2050-084X
Container-title:eLife
language:en
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Author:

Bespalov Anton¹^ORCID,Bernard René²³⁴^ORCID,Gilis Anja⁵,Gerlach Björn¹^ORCID,Guillén Javier⁶^ORCID,Castagné Vincent⁷^ORCID,Lefevre Isabel A⁸^ORCID,Ducrey Fiona⁹,Monk Lee¹⁰,Bongiovanni Sandrine¹¹^ORCID,Altevogt Bruce¹²^ORCID,Arroyo-Araujo María¹³^ORCID,Bikovski Lior¹⁴¹⁵^ORCID,de Bruin Natasja¹⁶^ORCID,Castaños-Vélez Esmeralda²^ORCID,Dityatev Alexander¹⁷¹⁸¹⁹^ORCID,Emmerich Christoph H¹^ORCID,Fares Raafat²⁰^ORCID,Ferland-Beckham Chantelle²¹,Froger-Colléaux Christelle⁷^ORCID,Gailus-Durner Valerie²²,Hölter Sabine M²³^ORCID,Hofmann Martine CJ¹⁶^ORCID,Kabitzke Patricia²⁴²⁵^ORCID,Kas Martien JH¹³^ORCID,Kurreck Claudia²,Moser Paul²⁶²⁷,Pietraszek Malgorzata¹,Popik Piotr²⁸^ORCID,Potschka Heidrun²⁹,Prado Montes de Oca Ernesto³⁰³¹³²^ORCID,Restivo Leonardo³³,Riedel Gernot³⁴,Ritskes-Hoitinga Merel³⁵³⁶^ORCID,Samardzic Janko³⁷^ORCID,Schunn Michael³⁸^ORCID,Stöger Claudia²²^ORCID,Voikar Vootele³⁹^ORCID,Vollert Jan⁴⁰,Wever Kimberley E³⁵^ORCID,Wuyts Kathleen⁴¹,MacLeod Malcolm R⁴²^ORCID,Dirnagl Ulrich²³⁴^ORCID,Steckler Thomas⁵

Affiliation:

1. PAASP, Heidelberg, Germany

2. Department of Experimental Neurology, Charité Universitätsmedizin, Berlin, Germany

3. NeuroCure Cluster of Excellence, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany

4. QUEST Center for Transforming Biomedical Research, Berlin Institute of Health at Charite, Berlin, Germany

5. Janssen Pharmaceutica NV, Beerse, Belgium

6. AAALAC International, Pamplona, Spain

7. Porsolt, Le Genest-Saint-Isle, France

8. Rare and Neurologic Diseases Research, Sanofi, Chilly-Mazarin, France

9. Integrity and Global Research Practices, Sanofi, Chilly-Mazarin, France

10. Research and Clinical Development Quality, UCB, Slough, United Kingdom

11. Quality Assurance, Novartis Institutes for BioMedical Research, Novartis Pharma, Basel, Switzerland

12. Pfizer Inc., Silver Spring, United States

13. Groningen Institute for Evolutionary Life Sciences, University of Groningen, Groningen, Netherlands

14. School of Behavioral Sciences, Netanya Academic College, Netanya, Israel

15. The Myers Neuro-Behavioral Core Facility, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel

16. Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt am Main, Germany

17. Molecular Neuroplasticity, German Center for Neurodegenerative Diseases, Magdeburg, Germany

18. Center for Behavioral Brain Sciences, Magdeburg, Germany

19. Medical Faculty, Otto-von-Guericke University, Magdeburg, Germany

20. Charles River Laboratories, Safety Assessment, Lyon, France

21. Cohen Veterans Bioscience, Boston, United States

22. German Mouse Clinic, Institute of Experimental Genetics, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg, Germany

23. Institute of Developmental Genetics, Helmholtz Zentrum München, German Research Center for Environmental Health, and Technical University Munich, Munich, Germany

24. PAASP US, Ridgefield, United States

25. The Stanley Center for Psychiatric Research, Broad Institute of MIT and Harvard, Cambridge, United States

26. Cerbascience, Toulouse, France

27. PAASP France, Toulouse, France

28. Maj Institute of Pharmacology, Polish Academy of Sciences, Krakow, Poland

29. Institute of Pharmacology, Toxicology and Pharmacy, Ludwig-Maximilians-University, Munich, Germany

30. Personalized Medicine Laboratory (LAMPER), Research Center inTechnology and Design Assistance of Jalisco State, National Council of Science andTechnology (CIATEJ-CONACYT), Mexico, Mexico

31. Scripps Research Translational Institute, La Jolla, United States

32. Integrative Structural and Computational Biology, Scripps Research, La Jolla, United States

33. Neuro-BAU, Department of Fundamental Neurosciences, Faculty of Biology and Medicine,University of Lausanne, Lausanne, Switzerland

34. Institute of Medical Sciences, University of Aberdeen, Scotland, United Kingdom

35. SYRCLE, Department for Health Evidence, Radboud University Medical Center, Nijmegen, Netherlands

36. Department for Clinical Medicine, Aarhus University, Aarhus, Denmark

37. Institute of Pharmacology, Medical Faculty, University of Belgrade, Belgrade, Serbia

38. Institute of Science and Technology, Klosterneuburg, Austria

39. Neuroscience Center and Laboratory Animal Center, Helsinki Institute of Life Science, University of Helsinki, Helsinki, Finland

40. Pain Research, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, United Kingdom

41. Avertim, Brussels, Belgium

42. Centre for Clinical Brain Sciences, University of Edinburgh, Scotland, 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. 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.

Funder

Innovative Medicines Initiative

Publisher

eLife Sciences Publications, Ltd

Subject

General Immunology and Microbiology,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Link

https://cdn.elifesciences.org/articles/63294/elife-63294-v2.pdf

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