TY - JOUR
T1 - Introduction to the EQIPD quality system
AU - Bespalov, Anton
AU - Bernard, René
AU - Gilis, Anja
AU - Gerlach, Björn
AU - Guillen, Javier
AU - Castagne, Vincent
AU - Lefevre, Isabel
AU - Ducrey, Fiona
AU - Monk, Lee
AU - Bongiovanni, Sandrine
AU - Altevogt, Bruce
AU - Arroyo Araujo, Maria
AU - Bikovski, Lior
AU - de Bruin, Natasja
AU - Castaños-Vélez, Esmeralda
AU - Dityatev, Alexander
AU - Emmerich, Christoph H
AU - Fares, Raafat
AU - Ferland-Beckham, Chantelle
AU - Froger-Colléaux, Christelle
AU - Gailus-Durner, Valerie
AU - Hölter, Sabine M
AU - Hofmann, Martine Cj
AU - Kabitzke, Patricia
AU - Kas, Martien J H
AU - Kurreck, Claudia
AU - Moser, Paul
AU - Pietraszek, Malgorzata
AU - Popik, Piotr
AU - Potschka, Heidrun
AU - Prado Montes de Oca, Ernesto
AU - Restivo, Leonardo
AU - Riedel, Gernot
AU - Ritskes-Hoitinga, Merel
AU - Samardzic, Janko
AU - Schunn, Michael
AU - Stöger, Claudia
AU - Voikar, Vootele
AU - Vollert, Jan
AU - Wever, Kimberley E
AU - Wuyts, Kathleen
AU - MacLeod, Malcolm R
AU - Dirnagl, Ulrich
AU - Steckler, Thomas
N1 - Fundings: Innovative Medicines Initiative (777364) to Malcolm R MacLeod.
The funders had no role in study design, data collection and interpretation, or the decision to submit the work for publication.
PY - 2021/6/7
Y1 - 2021/6/7
N2 - 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.
AB - 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.
U2 - 10.7554/eLife.63294
DO - 10.7554/eLife.63294
M3 - Article
C2 - 34028353
VL - 10
JO - eLife
JF - eLife
M1 - e63294
ER -