At a Glance
  • Status: Active Consortium
  • Year Launched: 2009
  • Initiating Organization: Innovative Medicines Initiative
  • Initiator Type: Government
  • Disease focus:
    Copd
  • Location: Europe

Abstract

The PROactive project aims to develop validation and use of patient-reported outcome (PRO) tools to investigate dimensions of physical activity that are judged as being essential by patients living with Chronic Obstructive Pulmonary Disease (COPD). The aim of the 60-month long consortium is to develop new tools that will enable patients, their doctors, and clinical researchers to accurately assess the improvement or deterioration of COPD.

Mission

The PROactive consortium is part of the European Commission’s Innovative Medicines Initiative (IMI) with aims to develop validation and use of patient-reported outcome tools to investigate dimensions of physical activity that are judged as being essential by patients living with Chronic Obstructive Pulmonary Disease. The PROactive consortium will develop patient-reported outcome tools that detect small but clinically relevant changes in physical activity and their related symptoms, and, as such, it will offer results more relevant to patients and doctors. A user-friendly electronic tool will help patients to assess on a day-to-day basis the activities in which they engage and the symptoms associated to these activities. The second tool will be used during hospital visits to assess the patients' physical activity and experience of the disease. To verify the usefulness of the tools, they will be tested in clinical trials with more than 600 COPD patients. The European Medicines Agency and the U.S. Food and Drug Administration will be closely involved in the developments.

Consortium History

2009 – Project start date
2011 – IMI lung disease projects present finding to press and patients (September)
2013 – PROactive and COPDMAP sign Memorandum of Understanding to join forces on COPD work (July)

Structure & Governance

Project Coordinators:
Mario Scuri
Dr. Caterina Brindicci

Managing entity of IMI beneficiaries & coordinator of scientific activities:
Thierry Troosters

Within the PROactive project, there are two advisory boards that pro-actively oversee the progress of the project and tackle any issues that may arise. The boards ensure that the project is ethical and safe and that it meets the needs of patients.

The two advisory boards are:

Financing

This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union (EU) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), resources of which are composed of financial contribution from the EU Seventh Framework Programme and EFPIA companies’ in-kind contributions. Large Pharmaceutical companies participating in IMI projects do not receive IMI funding.

The IMI Intellectual Property (IP) Policy governs the IP regime of all projects funded by the IMI JU.  To assist with specific IP queries, IMI has set up a dedicated IP Helpdesk, which can be contacted by e-mailing IMI-IP-Helpdesk@imi.europa.eu. The IMI IP policy can be accessed at the following address: http://www.imi.europa.eu/sites/default/files/uploads/documents/imi-ipr-policy01august2007_en.pdf

Data Sharing

According to IMI’s intellectual property policy, the participants undertake to disseminate the data as soon as reasonably practicable but not later than one year after the termination or expiry of the project. The Project Agreement shall include a description of the material that must be disseminated in accordance with the IP Policy and referenced in the Grant Agreement. If the participants do not disseminate within such time periods without good reason, the Executive Office has the right to disseminate such results in a manner consistent with the Grant Agreement.

Points of Contact

Mario Scuri
Chiesi Farmaceutici S.p.A.
Parma
Italy
Tel: +39 0521 1689228
Email: M.Scuri@chiesi.com

Sponsors & Partners

Chiesi Farmaceutici S.p.A, Parma, Italy (Project Coordinator)

GlaxoSmithKline Research and Development LTD, Brentford, UK

Pfizer Limited, Sandwich, UK

Almirall, S.A., Barcelona, Spain

Novartis Pharma AG, Basel, Switzerland

AstraZeneca AB, Södertälje, Sweden

UCB Pharma SA, Brussels, Belgium

Boehringer Ingelheim International GmbH, Ingelheim, Germany

Katholieke Universiteit Leuven, Leuven, Belgium

The University of Edinburgh, Edinburgh, UK

Thorax – Research Center of Intensive & Emergency Thoracic Medicine, Athens, Greece

Royal Brompton & Harefield NHS Foundation Trust, London, UK

Fundacio IMIM, Barcelona, Spain

Universität Zürich, Zurich, Switzerland

Academisch Ziekenhuis Groningen / University Medical Center Groningen, Groningen, Netherlands

Astma Fonds Longstichting, Leusden, Netherlands

British Lung Foundation, London, UK

European Respiratory Society, Lausanne, Switzerland

Choice Pharma, Hitching, UK


Last Updated: 04/15/2016

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