Introduction to the EQIPD quality system
- PAASP, Germany
- Charité Universitätsmedizin, Germany
- Janssen Pharmaceutica NV, Belgium
- PAASP GmbH, Germany
- AAALAC International, Spain
- Porsolt, France
- Sanofi, France
- UCB, United Kingdom
- Novartis pharma, Switzerland
- Pfizer, United States
- University of Groningen, Netherlands
- Tel Aviv University, Israel
- Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Germany
- Deutsches Zentrum für Neurodegenerative Erkrankungen e.V. (DZNE), Germany
- Charles River Laboratories, France
- Cohen Veterans Bioscience, United States
- German Mouse Clinic, Germany
- Helmholtz Zentrum München, Germany
- Broad Institute of MIT & Harvard, United States
- PAASP, France
- Polish Academy of Sciences, Poland
- Institute of Pharmacology, Toxicology, and Pharmacy, Germany
- National Council of Science and Technology, Mexico
- The University of Lausanne, Switzerland
- University of Aberdeen, United Kingdom
- Radboud University Medical Center, Netherlands
- University of Belgrade, Serbia
- Institute of Science and Technology, Austria
- University of Helsinki, Finland
- Imperial College London, United Kingdom
- Avertim, Belgium
- 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.
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Article and author information
Author details
Sandrine Bongiovanni
Esmeralda Castaños-Vélez
Alexander Dityatev
Ernesto Prado Montes de Oca
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.
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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Introduction to the EQIPD quality system
eLife 10:e63294.
https://doi.org/10.7554/eLife.63294
