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. 2021 May 24:10:e63294.
doi: 10.7554/eLife.63294.

Introduction to the EQIPD quality system

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

Introduction to the EQIPD quality system

Anton Bespalov et al. Elife. .

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.

Keywords: drug discovery; neuroscience; nonregulated research; research rigor.

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Conflict of interest statement

AB AB is an employee and/or shareholder at PAASP GmbH, PAASP US LLC, Exciva GmbH, Synventa LLC, Ritec Pharma, RB, MA, LB, Nd, EC, AD, RF, VG, SH, MH, MK, MP, PP, EP, LR, GR, MR, JS, MS, CS, VV, JV, KW No competing interests declared, AG AG are employees of Janssen / Johnson & Johnson and shareholders at Johnson & Johnson, BG, CE BG and CE are employees and shareholders at PAASP GmbH. JG JG is an employee of AAALAC International that is an EQIPD Associated Collaborator. VC, CF VC and CFC are employees of Porsolt. IL, FD IAL and FD are employees of Sanofi. LM LM is an employee and shareholder of UCB. SB SB is an employee of Novartis Pharma. BA 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. CF 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. PK PK is an employee and shareholder at PAASP US LLC. CK UD and CK receive funding from Volkswagen Foundation, PM PM is owner of Cerbascience Consulting, HP HP has received during the last three years consulting and speaking fees and/or funding for collaborative projects from Bayer, Roche, Zogenix, and Eisai. KW KW is a consultant of Avertim, Brussels, Belgium, support for this contribution was funded by Janssen Pharmaceutica NV. MM MM, UD and TS are members of the Advisory Board at PAASP. MM, UD and TS are members of the ARRIVE guidelines working group. UD 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. TS 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.

Figures

Figure 1.
Figure 1.. Flexible sequence of implementation of the EQIPD core requirements.
Depending on the current needs, a research unit may prioritize the implementation of one or another core requirement. For example, tasks related to core requirement ‘B’ are highly relevant for the research unit’s parent institution, the funding organization and a scientific journal where the research team plans to publish the results of their work. In contrast, core requirement ‘C’ is of lower importance and can, therefore, be addressed at a later timepoint.
Box 1—figure 1.
Box 1—figure 1.. Areas of risk assessment.
Box 2—figure 1.
Box 2—figure 1.. Types of self-assessment activities.
Figure 2.
Figure 2.. Implementation of the EQIPD Quality System (QS): From Core Requirements (CR) to assessment of a fully functional system.
The 18 CRs are the expectations formulated by EQIPD that serve as the starting point for implementing the QS. At any step during the implementation, the use of EQIPD tools is voluntary and serves only the purpose of making the implementation and maintenance of the QS easier. As the first step, unless such information is available from other sources, the research unit may consult with the Toolbox to obtain relevant research quality-related information. Once the necessary information is obtained, the research unit applies this knowledge and monitors the progress. This can be done using the Planning Tool, using alternative project management resources or even without any such tools. The Dossier is a repository of documents and information that are specific to the user’s research unit and that is organized according to a structure suggested by EQIPD (to keep all research quality-related information in one place and make it easily findable). However, the research unit may also opt to use its own way to store information. Finally, once the implementation is completed, the research unit may initiate an assessment to get feedback from experts outside of the research unit (either quality professionals within the same organization or a third party).
Figure 3.
Figure 3.. The proposed future governance model of EQIPD.
The EQIPD Guarantors group and the EQIPD Ethics and Advisory Board are responsible for the overall guidance, administration of academic and educational programs, as well as dissemination of the EQIPD vision (Strategic level). An independent partner organization, commissioned by the EQIPD Guarantors, will provide the operational support and the day-to-day services for the EQIPD community (Operational level). The EQIPD Stakeholder group, composed of scientists, funders, quality professionals, manufacturers of research tools, and publishers, provides feedback on the practical aspects of the EQIPD Quality System and facilitates connections to a broader biomedical research community (Community level).
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