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Name EQIPD
Long Name European Quality In Preclinical Data
Description European Quality In Preclinical Data. EQIPD goal is to deliver simple recommendations to facilitate data quality without impacting innovation.The project team will start by analysing the variables in study design and data analysis that influence outcomes and establishing whether these are the same in academia and industry. They will then define the components of an EQIPD quality management system and work to achieve a consensus among different stakeholders on quality management recommendations for research. They will also assess the feasibility of the quality management system in prospective studies in the fields of neuroscience and safety. Finally, the project will set up an online educational platform that will deliver certified courses in the principles and application of data quality and rigour. This, combined with the involvement in the project of many junior scientists, will pave the way for a cultural change in approaches to data quality in the medical research and drug development field.
Objectives 1. Define the 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. 2. Establish whether these are the same variables which influence outcome in academia. 3. Define the components which will make up the EQIPD quality management system. 4. Define consensus quality management recommendations for non-regulated research and development. 5. Validate the feasibility of the quality management system in prospective studies. 6. Deliver an online educational platform providing certified education and training in the principles and application of quality and rigour.
Website https://quality-preclinical-data.eu
Start date 01-10-2017
End date 30-09-2021
Logo
Name Projects Type of institution Country  
University Of Edinburgh EPAD AMYPAD EQIPD ROADMAP Academia United Kingdom
Janssen Pharmaceutica NV EPAD ADAPTED AMYPAD IMPRiND EQIPD NEURONET EMIF IM2PACT PHAGO PRISM RADAR-CNS RADAR-AD ROADMAP IDEA-FAST Pharma-Cog EPND EFPIA Belgium
F. Hoffmann-La Roche AG EPAD EQIPD EMIF PHAGO PRISM ROADMAP NEURONET IDEA-FAST Pharma-Cog EPND EFPIA Switzerland
Sanofi-Aventis Recherche & Developpement EPAD EQIPD AETIONOMY IM2PACT PHAGO NEURONET Mobilise-D IDEA-FAST EPND EFPIA France
Novartis Pharma AG EPAD IMPRiND EQIPD AETIONOMY IM2PACT PRISM RADAR-AD ROADMAP Mobilise-D Pharma-Cog EPND EFPIA Switzerland
Pfizer Limited EPAD EQIPD EMIF IM2PACT PRISM Mobilise-D IDEA-FAST EFPIA United Kingdom
UCB Biopharma SPRL EPAD EQIPD AETIONOMY EMIF PD-MitoQUANT RADAR-CNS IDEA-FAST Pharma-Cog EPND EFPIA Belgium
Stichting Katholieke Universiteit / Radboud University Nijmegen Medical Centre EPAD EQIPD PRISM AMYPAD PD-MitoQUANT PRISM2 Academia Netherlands
Boehringer Ingelheim International Gmbh PRISM EPAD EQIPD AETIONOMY EMIF Pharma-Cog PRISM2 EFPIA Germany
Rijksuniversiteit Groningen PRISM EQIPD ROADMAP PRISM2 Academia Netherlands
Stichting Buro Ecnp PRISM EQIPD PRISM2 Academia Netherlands
Concentris Research Management GmbH PRISM EQIPD EMIF PRISM2 SME Germany
Institut De Recherches Servier IMPRiND EMIF EQIPD Pharma-Cog Academia France
Abbvie Inc. EQIPD IDEA-FAST EFPIA United States
Orion Oyj EQIPD PHAGO IDEA-FAST EFPIA Finland
Psychogenics Inc EQIPD PRISM2 EFPIA United States
Charite - Universitaetsmedizin Berlin EQIPD PHAGO RADAR-CNS Academia Germany
Eberhard Karls Universitaet Tuebingen EQIPD Academia Germany
Imperial College Of Science Technology And Medicine EQIPD Mobilise-D IDEA-FAST Academia United Kingdom
Ludwig-Maximilians-Universitaet Muenchen EQIPD Academia Germany
University Of Aberdeen EQIPD Academia United Kingdom
Universitaet Bern EQIPD Academia Switzerland
Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz EQIPD IM2PACT Academia Germany
Noldus Information Technology BV EQIPD SME Netherlands
Paasp Gmbh EQIPD EFPIA Germany
Porsolt SAS EQIPD SME France
Science Exchange Inc EQIPD SME United States
Synaptologics BV EQIPD SME Netherlands
Pharmalex Belgium EQIPD Other Belgium
Teva Pharmaceutical Industries Limited PD-MitoQUANT Mobilise-D EQIPD EPND EFPIA Israel
Arlenda EQIPD SME Belgium
WP number Description Project  
WP1 Project management and oversight EQIPD
WP2 Historical data analysis EQIPD
WP3 Development of guiding principles to improve preclinical robustness EQIPD
WP4 Prospective cross-site validation of guiding principles in specific assay EQIPD
WP5 New quality management system in emerging and classical technologies to improve preclinical robustness EQIPD
WP6 Governance of the new quality system EQIPD
WP7 E-learning course on scientific quality EQIPD
WP8 Data management EQIPD
WP9 Ethics requirements EQIPD
Deliverable number Title Project Submission date Link Keywords  
D1.5 First quarterly electronic bulletin EQIPD 30-03-2018 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5b9a3ad98&appId=PPGMS
D4.1 Obtain ethical approval for cross-site validation studies and ring testing EQIPD 30-07-2018 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5bc97dca9&appId=PPGMS
D8.1 Data Inclusion Protocol EQIPD 30-10-2017 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5b66a2ec3&appId=PPGMS
D4.3 Outcome report from cross site validation EQIPD 30-04-2019 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5c3dc1941&appId=PPGMS
D4.2 With input from WPs 2 and 3 develop harmonised protocols for cross validation testing EQIPD 30-04-2019 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5c3dc043b&appId=PPGMS
D7.2 Structure and first incentives for electronic community enabling social learning, hosted on a web-based platform EQIPD 24-04-2019 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5c3c62681&appId=PPGMS
D1.1 First press release EQIPD 30-10-2017 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5b66a224b&appId=PPGMS
D1.4 Release of project website public and internal part, communication package (logo, flyer, social media announcement) EQIPD 30-03-2018 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5b9a3a9e4&appId=PPGMS
D7.1 Evaluation of Existing Training Modules EQIPD 30-04-2019 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5c3b0c9cb&appId=PPGMS
D8.2 1st Technical diagram of EQIPD-DWH EQIPD 20-12-2017 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5b753c157&appId=PPGMS
D8.5 Data sharing procedures beyond EQIPD EQIPD 31-03-2020 https://quality-preclinical-data.eu/wp-content/uploads/2021/01/EQIPD_Deliverable-report_D8.5_Final.pdf
D2.5 Report on factors that underlie the robustness and generalisability of commonly used assays EQIPD 20-12-2021 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5e62e013b&appId=PPGMS
D4.5 Report on validated guiding principles for robustness and data quality in preclinical Neuroscience and Safety research Lead EQIPD 22-04-2021 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5e62e013b&appId=PPGMS
D4.4 Outcome report from harmonized testing EQIPD 30-09-2020 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5d644b9be&appId=PPGMS
D3.2 Final version of the framework of key principles and criteria for guiding the design, conduct and analysis of preclinical efficacy and safety research EQIPD 25-11-2021 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5e4fcda1b&appId=PPGMS
D5.4 Final version of quality assurance system ready for implementation in industry and academia in non-regulated research EQIPD 01-10-2020 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5d4219317&appId=PPGMS
D4.6 Outcome report from Ring testing EQIPD 29-11-2021 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5e52ae853&appId=PPGMS
D7.3 Comprehensive, engaging, selection of training materials on scientific quality, hosted on a web-based platform EQIPD 30-08-2021 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5e1717c81&appId=PPGMS
D5.3 Quality reporting module in research software (prototype) EQIPD 29-04-2020 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5e4e06a96&appId=PPGMS
Title First author last name Year Project Link Keywords  
Commentary on the BJP's new statistical reporting guidelines Motulsky 2018 EQIPD https://doi.org/10.1111/bph.14441 Commentary, data analysis, statistics, sample size, control, treatment, clinical research
Protocol for a systematic review of guidelines for rigour in the design, conduct and analysis of biomedical experiments involving laboratory animals Vollert 2018 EQIPD https://openscience.bmj.com/content/2/1/e000004 Systematic review protocol, animal experiments, biomedical, statistical, design,
Minimum Information in In Vivo Research Voehringer 2019 EQIPD https://doi.org/10.1007/164_2019_285 Review article, animal behavior, data quality, in vivo, publication reporting, reproducibility, standards
Design of Meta-Analysis Studies Macleod 2019 EQIPD https://doi.org/10.1007/164_2019_289 Methodology paper, meta-analysis, systematic review, preclinical research
A European initiative to unclog pipeline for new medicines Macleod 2019 EQIPD https://doi.org/10.1038/d41586-019-01293-5 Commentary article, quality management, preclinical research, assessment
Learning from Principles of Evidence-Based Medicine to Optimize Nonclinical Research Practices Lefevre 2019 EQIPD https://doi.org/10.1007/164_2019_276 Review article, preclinical research, data reliability, decision-making, evidence-based medicine, nonclinical pharmacology, research methodology
Guidelines and Initiatives for Good Research Practice Kabitzke 2019 EQIPD https://doi.org/10.1007/164_2019_275 Review article, good research practice, data quality, preclinical research, reproducibility
General Principles of Preclinical Study Design Huang 2019 EQIPD https://doi.org/10.1007/164_2019_277 Review article, experimental bias, study design, hypothesis testing, preclinical research, in vivo
Synaptic dysfunction and memory impairments in transgenic Alzheimer ’s disease models : A systematic review protocol Hair 2019 EQIPD https://osf.io/btqw2/ Systematic review protocol, alzheimer's disease, preclinical research, behaviour testing, in vivo
Good Research Practice: Lessons from Animal Care and Use Guillen 2019 EQIPD https://doi.org/10.1007/164_2019_292 Review article, preclinical research, in vivo, animal care and use, preclinical data quality
Quality Governance in Biomedical Research Gilis 2019 EQIPD https://doi.org/10.1007/164_2019_291 Review article, GLP, quality governance, research data quality, preclinical research, in vivo, guidelines
Electronic Lab Notebooks and Experimental Design Assistants Gerlach 2019 EQIPD https://doi.org/10.1007/164_2019_287 Review article, data management, documenting experiments, lab book, reproducibility, data quality
Building Robustness into Translational Research Erdogan 2019 EQIPD https://doi.org/10.1007/164_2019_283 Review article, preclinical research, translational, guidelines, heterogeneity, age, study design
Resolving the Tension Between Exploration and Confirmation in Preclinical Biomedical Research Dirnagl 2019 EQIPD https://doi.org/10.1007/164_2019_278 Review article, preclinical research, randomisation, study design, reproducibility, statistics, data quality
Quality in Non-GxP Research Environment Bongiovanni 2019 EQIPD https://doi.org/10.1007/164_2019_274 Review article, good research practice, preclinical research, reproducibility, data quality, experimental science, guidelines, quality control
Blinding and Randomization Bespalov 2019 EQIPD https://doi.org/10.1007/164_2019_279 Review article, good research practice, randomisation, blinding, preclinical research, guidelines
Be positive about negatives–recommendations for the publication of negative (or null) results Bespalov 2019 EQIPD https://doi.org/10.1016/j.euroneuro.2019.10.007 Review article, commentary, good research practice, negative results, reproducibility, publication bias
New Author Guidelines for Displaying Data and Reporting Data Analysis and Statistical Methods in Experimental Biology Michel 2020 EQIPD https://doi.org/10.1124/dmd.119.090027 Commentary, guidelines, preclinical research, statistics, reproducibility, data quality, in vivo
Normalization of organ bath contraction data for tissue specimen size: does one approach fit all? Erdogan 2020 EQIPD https://doi.org/10.1007/s00210-019-01727-x Basic science research paper, contractility, preclinical research, data variability, translational science
Do overactive bladder symptoms and their treatment‐associated changes exhibit a normal distribution? Implications for analysis and reporting Amiri 2020 EQIPD https://doi.org/10.1002/nau.24275 Systematic review article, clinical research, bladder, urology, reporting, analysis
The open field test protocol in transgenic Alzheimer’s disease models: A systematic review protocol Hair 2020 EQIPD https://doi.org/10.17605/OSF.IO/E4WBF studies, treatment, anxiety, data, animal, outcome, test, efficacy, animals, review
Good Research Practice in Non-Clinical Pharmacology and Biomedicine Bespalov 2020 EQIPD https://doi.org/10.1007/978-3-030-33656-1 studies, treatment, anxiety, data, animal, outcome, test, efficacy, animals, review
Introduction to the EQIPD quality system Bespalov 2021 EQIPD https://doi.org/10.7554/elife.63294 neuroscience
The perks of a Quality System in academia Arroyo-Araujo 2022 EQIPD https://doi.org/10.1016/j.nsa.2022.100001 preclinical data quality, quality system, rigorous research practices
Systematic review of guidelines for internal validity in the design, conduct and analysis of preclinical biomedical experiments involving laboratory animals Vollert 2020 EQIPD https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8647591/ scientific rigor, bias, internal validity, preclinical studies, animal studies
Title Description Type Project  
Animal data from multi-site experiments

EQIPD has obtained study reports for historical data from EFPIA partners, CROs and academic labs, and calculate the prevalence of reporting of measures to increase internal validity. An initial survey of available datasets suggests availability for the Irwin test (47 experiments), Morris Water Maze (69), Y/T mazes (50), prepulse inhibition (56), novel object recognition tasks (35), and sleep/wake (72) and circadian (37) EEG. For mroe information, please visit:

https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5c3dc043b&appId=PPGMS

dataset-non-clinical-equip-2 EQIPD
EQIPD Quality System

The EQIPD Quality System (QS) is a flexible, fit for-purpose, lean and user-friendly quality management system for non-regulated drug discovery research. It includes guidelines, procedures & a certification system for preclinical research. The objective of the EQIPD QS is to support the essential processes, procedures, responsibilities and cultural aspects relevant to implement the guiding principles that improve robustness of preclinical studies (e.g. regulatory aspects, recommendations for publications and funding applications, etc). For more information, please visit:

General information: https://eqipd-toolbox.paasp.net/wiki/Toolbox
White paper: https://osf.io/ng32b

Further information about the EQIPD Quality System (why, what and how) can also be viewed in the following 4 short videos:

EQIPD intro Part 1: Why (https://www.youtube.com/watch?v=hOaCILTwcU4)
EQIPD intro Part 2: What (https://www.youtube.com/watch?v=bK6emsX5G1Y)
EQIPD intro Part 3: How (https://www.youtube.com/watch?v=D_Wl6kcs9vU)
EQIPD intro Part 4: Why Quality Matters (https://eqipd-toolbox.paasp.net/wiki/Why_quality_matters)

tools-non-clinical-eqipd-11 EQIPD
Handbook of good research practice in non-clinical pharmacology and biomedicine

To disseminate aligned approaches to rigor in nonregulated applied research, academic and industry members of EQIPD have produced an open-access Handbook of Experimental Pharmacology volume dedicated to various aspects of good research practice.
For more information, please visit:
https://rd.springer.com/book/10.1007/978-3-030-33656-1

tools-non-clinical-eqipd-12 EQIPD
Living systematic review

EQIPD is conducting a “living” systematic review to identify universally-applicable guiding principles and criteria governing rigour in the design, conduct, analysis and reporting of preclinical neuroscience and safety research. The living systematic review screens primary research in AD, with approximately 26,000 publications identified and 13,863 papers screened so far (updated October 2019). For more information, please see:

https://openscience.bmj.com/content/4/1/e100046

tools-non-clinical-eqipd-13 EQIPD
EQIPD Training Platform

EQIPD has developed an online educational platform providing education and training in the principles and application of quality and rigour in preclinical studies, where there are currently a number of e-learning modules available. In addition, as part of EQIPD’s learning environment, EQIPD organizes an annual workshop in collaboration with the ECNP Preclinical Data Network. For more information, please visit: 

https://quality-preclinical-data.eu/learning-environment/eqipd-e-learning/

training-non-clinical-eqipd-3 EQIPD
EQIPD Quality Label

EQIPD has developed an assessment procedure that aims to confirm a research unit’s compliance with the EQIPD expectations about research rigor and data integrity. The EQIPD Quality Label can be awarded to both organizations with fully implemented Quality System (to indicate long-term maintenance of high-quality standards) and organizations meeting key expectations about research rigor and data integrity (to indicate current adherence to high quality standards to be maintained over short period of time required for a specific project or collaboration).

For more information, please contact: info@eqipd.online

tools-non-clinical-eqipd-23 EQIPD
A guidance for core facilities

EQIPD is developing guidance intended to support application of EQIPD quality standards in research projects involving core facilities.

For more information, please visit:

https://eqipd-toolbox.paasp.net/wiki/1.4.3.3_Academia-academia:_Research_as_service

tools-non-clinical-eqipd-24 EQIPD
A tool to support sponsored research

EQIPD has developed a tool intended to support organizations that outsource nonregulated research activities. Using this tool, sponsors of research can select service providers based on adherence to good research practice criteria.

The tool can also be used by service providers (e.g., contract research organizations) to review various aspects of research rigor and data management that are important for the sponsors.

The tool has been successfully implemented on the Scientist.com and Science Exchange platforms, leading marketplaces for outsourced R&D activities.
(e.g., Scientist.com https://www.businesswire.com/news/home/20201201005416/en/Scientist.com-Expands-Award-Winning-Compliance-Platform-to-Include-International-Research-Consortium’s-Preclinical-Study-Standards and ScienceExchange https://blog.scienceexchange.com/2020/11/science-exchange-partners-with-joint-pharmaacademic-consortium-to-improve-research-reproducibility/).

tools-non-clinical-eqipd-25 EQIPD
A guidance for industry-academia collaboration

EQIPD has developed guidance intended to improve the traceability and integrity of data obtained through research as part of an academic-industry collaboration. For more information, please visit:

https://eqipd-toolbox.paasp.net/wiki/1.4.3.2_Industry-academia:_Research_as_collaboration#Background

tools-non-clinical-eqipd-26 EQIPD
Online toolbox

EQIPD has developed a Toolbox, an online wiki-based platform that intends to collect and disseminate all information (guidelines, tools, literature, web links, etc.) related to various aspects of research rigor.
The platform is open to any member of the research community to register and contribute information and resources.
Further information:
https://eqipd-toolbox.paasp.net/wiki/Toolbox

tools-non-clinical-eqipd-27 EQIPD
Living Evidence AD Decision Modelling

The project operating in the area of the preclinical data quality in neurosciences developed the database/data catalogue "Living Evidence AD", which can be used for pre-clinical Alzheimer’s disease (AD) decision modelling. The tool provides a summary of all transgenic drug testing studies in AD; it is therefore of value in informing scoping exercises where scientists or companies wish to contextualise their proposed research against what has gone before; and as a starting point (with the opportunity to download a bibliographic record of the search) for those wishing to conduct a systematic review.

https://camarades.shinyapps.io/LivingEvidence_AD/

dataset-clinical-eqipd-15 EQIPD
Ontology for describing animal experiments

EQIPD will establish an ontology for describing animal experiments, in compliance with FAIR data principles. For more information, please visit:

https://link.springer.com/chapter/10.1007%2F164_2019_277

ontologies-non-clinical-eqipd-2 EQIPD

 

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