Objective
Pharmaceutical industry, as well as basic science, depend on robust data and scientific rigor as key drivers for decision making, patent strength and time-to-market, which in turn will determine knowledge gain and availability of new treatments to patients. Recent publications report challenges with the robustness, rigor, and/or validity of research data, which may impact decisions about whether to proceed to preclinical and clinical testing as well as conclusions on the predictability of preclinical models. There is a need for simple, sustainable solutions that facilitate data quality.
We will propose simple, sustainable solutions that facilitate data quality without impacting innovation and freedom of research. Our consortium will pool resources from both academia and industry to pilot this action in Neuroscience and Safety, but with applicability beyond these R&D areas.
The European Quality In Preclinical Data (EQIPD) consortium will
(i) define those variables in study design and data analysis that influence outcome in pre-clinical neuroscience (focus on Alzheimer’s disease and psychosis) and (neuro-)safety studies conducted in industry; and establish whether these are the same variables which influence outcome in academia;
(ii) define the components which will make up the EQIPD quality management system;
(iii) define consensus quality management recommendations for non-regulated R&D;
(iv) validate the feasibility of the quality management system in prospective studies;
(v) deliver an online educational platform providing certified education and training in the principles and application of quality and rigour.
We will use systematic review and meta-analysis of historical data sets from industry and academia to identify variables of study design which determine outcomes in preclinical studies. Informed by the outcome of these analyses, we will use a Delphi approach to reach consensus around core principles for preclinical robustness, validate these approaches in cross site experiments and establish ring testing experiments in non-regulated research. We will develop a quality system framework to attest to compliance and a governance system to ensure sustainability and relevance. We will develop an educational platform to ensure research community-wide expansion of knowledge on criteria and principles necessary to address robustness and quality.
Junior researchers are involved in many of the tasks and are enrolled in an academia/industry joint exchange scheme. They will form the core from where a cultural change should emerge in form of a ripple effect.
Consortium members have made pivotal scientific and policy contributions relating to the robustness, rigor and validity of pre-clinical research in the past and together have the know-how and infrastructure necessary to succeed in this highly ambitious project.
Fields of science
Programme(s)
Funding Scheme
IMI2-RIA - Research and Innovation actionCoordinator
EH8 9YL Edinburgh
United Kingdom
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Participants (30)
69118 HEIDELBERG
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
82256 FURSTENFELDBRUCK
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
SW7 2AZ LONDON
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1435 Mont Saint Guibert
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AB24 3FX ABERDEEN
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9712CP Groningen
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3012 Bern
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55131 Mainz
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72074 Tuebingen
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10117 Berlin
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80539 MUNCHEN
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3584 BK Utrecht
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1008 BA AMSTERDAM
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
94301 PALO ALTO
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
53940 LE GENEST SAINT-ISLE
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
Participation ended
6525 XZ Nijmegen
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6709 PA Wageningen
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
2340 Beerse
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60064 North Chicago Il
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55218 Ingelheim
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4056 Basel
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02200 Espoo
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CT13 9NJ Sandwich
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NY10591 Tarrytown
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
4070 Basel
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91190 GIF-SUR-YVETTE
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1070 Bruxelles / Brussel
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94250 GENTILLY
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49131 Petach Tivka
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6525 GA Nijmegen
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