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European Quality In Preclinical Data

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.
Leaflet | Map data © OpenStreetMap contributors, Credit: EC-GISCO, © EuroGeographics for the administrative boundaries

Coordinator

THE UNIVERSITY OF EDINBURGH

Address

Old College, South Bridge
Eh8 9yl Edinburgh

United Kingdom

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 849 133,93

Participants (29)

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PAASP GMBH

Germany

EU Contribution

€ 362 337,50

Concentris Research Management GmbH

Germany

EU Contribution

€ 232 787

IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE

United Kingdom

EU Contribution

€ 371 072,39

ARLENDA SA

Belgium

PHARMALEX BELGIUM

Belgium

EU Contribution

€ 89 152,33

THE UNIVERSITY COURT OF THE UNIVERSITY OF ABERDEEN

United Kingdom

EU Contribution

€ 409 110,15

RIJKSUNIVERSITEIT GRONINGEN

Netherlands

EU Contribution

€ 456 524,98

UNIVERSITAET BERN

Switzerland

EU Contribution

€ 88 672,39

UNIVERSITAETSMEDIZIN DER JOHANNES GUTENBERG-UNIVERSITAET MAINZ

Germany

EU Contribution

€ 60 000

EBERHARD KARLS UNIVERSITAET TUEBINGEN

Germany

EU Contribution

€ 301 800,62

CHARITE - UNIVERSITAETSMEDIZIN BERLIN

Germany

EU Contribution

€ 292 502,56

LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN

Germany

EU Contribution

€ 368 299,49

STICHTING BURO ECNP

Netherlands

EU Contribution

€ 98 305,30

SYNAPTOLOGICS BV

Netherlands

EU Contribution

€ 110 628,71

SCIENCE EXCHANGE, INC.

United States

PORSOLT SAS

France

EU Contribution

€ 115 628,71

STICHTING KATHOLIEKE UNIVERSITEIT

Netherlands

EU Contribution

€ 200 414,61

NOLDUS INFORMATION TECHNOLOGY BV

Netherlands

EU Contribution

€ 89 152,33

JANSSEN PHARMACEUTICA NV

Belgium

ABBVIE INC

United States

BOEHRINGER INGELHEIM INTERNATIONALGMBH

Germany

NOVARTIS PHARMA AG

Switzerland

ORION OYJ

Finland

PFIZER LIMITED

United Kingdom

PSYCHOGENICS INC

United States

F. HOFFMANN-LA ROCHE AG

Switzerland

INSTITUT DE RECHERCHES SERVIER

France

UCB BIOPHARMA SPRL

Belgium

SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT

France

Project information

Grant agreement ID: 777364

Status

Ongoing project

  • Start date

    1 October 2017

  • End date

    30 September 2020

Funded under:

H2020-EU.3.1.7.

  • Overall budget:

    € 9 845 483,93

  • EU contribution

    € 4 495 523

Coordinated by:

THE UNIVERSITY OF EDINBURGH

United Kingdom