Project description
EU-integrated clinical trial platform
The EU-funded EU-PEARL project aims to transform the single-compound clinical trials system into EU-integrated research platforms for clinical trials management. Patient-centric data and knowledge-sharing across the EU will accelerate the development of new treatments and reduce the operational costs of clinical trials. EU-PEARL has the potential to improve clinical effectiveness, patient satisfaction and access to affordable medical treatment, while shaping a novel approach to future clinical trials. The main objectives of EU-PEARL are to create a transferable, accessible and affordable integrated research platform, accompanied by a management structure that can meet regulatory, ethical, legal, statistical and data requirements. Project results are to be disseminated and exploited to the highest standards, with trial-ready networks for major depressive disorder, tuberculosis, non-alcoholic steatohepatitis, and neurofibromatosis.
Objective
EU-PEARL has the ambition of transforming the current approach of conducting single-compound clinical trials into the use of cross-company Integrated Research Platforms (IRPs), taking into consideration both patients’ interests and the opportunities from novel molecules for addressing medical needs. Patient-centric data and knowledge sharing have the potential to accelerate the development of new treatments and reduce the operational costs of clinical trials. EU-PEARL will improve clinical effectiveness, patients’ satisfaction and societal access to timely and affordable medicines and it will shape the clinical trials of the future. This will change the industry paradigm from competition to cooperation in four disease areas and provide the framework for designing IRPs in other disease areas.
The main objectives of EU-PEARL are:
(1) To create a reusable, accessible and sustainable modular IRP for the design and execution of patient-centric, cross- company IRP in any disease area with unmet needs;
(2) To set up the open, dynamic, patient inclusive IRP governance structure that will manage the appropriate regulatory, ethical, legal, statistical and data utilisation requirements of the IRP;
(3) To disseminate and exploit the EU-PEARL paradigm through the provision of the necessary common tools, procedures, expertise and operational skills working to the highest scientific, regulatory and ethical standards and best practices, developed jointly by public and industry partners in a consensus-based approach; and
(4) To create trial-ready IRP networks in the four disease areas of Major Depressive Disorder (MDD), Tuberculosis (TB), Non-Alcoholic Steatohepatitis (NASH) and Neurofibromatosis (NF).
Fields of science
Keywords
Programme(s)
Funding Scheme
RIA - Research and Innovation actionCoordinator
08035 Barcelona
Spain
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Participants (40)
1081 HZ Amsterdam
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28006 Madrid
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
1090 Wien
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3000 Leuven
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WC2R 2LS London
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20132 Milano
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3015 GD Rotterdam
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80539 MUNCHEN
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10117 Berlin
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75012 Paris
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
75013 Paris
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9830 Sint-Martens-Latem
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
9860 OOSTERZELE
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OX14 5EG Abingdon
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
75014 Paris
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BRUSSELS Brussels / Bruxelles
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
40237 Dusseldorf
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NE1 7RU Newcastle Upon Tyne
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50676 Koln
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63225 Langen
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OX1 2JD Oxford
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20122 Milano
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10111 Tallinn
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
M13 9PL Manchester
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2340 Beerse
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4056 Basel
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Participation ended
Marlow
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151 85 Sodertaelje
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2880 Bagsvaerd
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80636 Munchen
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CT13 9NJ Sandwich
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94250 GENTILLY
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92284 Courbevoie
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49131 Petach Tivka
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10005 New York
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06902 Stamford Ct
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10005 NEW YORK
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08007 Barcelona
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
4354 ESCH SUR ALZETTE
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
60064 North Chicago Il
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