PatientPartner Southern European Regional Workshop

Defining the needs and means for more Partnership between Patients, Patient Organisations and Other Stakeholders in Clinical Trials

24 & 25 March 2010, Athens, Greece

Organised by EFGCP for the PatientPartner Project

When we think of the role of patients in clinical research, this might be limited to the thought of a patient being a ‘subject’ in a clinical trial. However, patients and patient organisations have much more to offer the clinical trial process. By using their experiential knowledge, patients have a potential role as partners in clinical research. A partnership between patients, patient organisations and the other key stakeholders – e.g. pharmaceutical companies and clinical researchers – will create new paradigms from which not only the patient will benefit, but also the quality, quantity and effectiveness of clinical research. In the end, such partnerships will contribute to better, patient-centred health care, and hopefully a more cost-effective quality research.

PatientPartner is a European project investigating, enforcing and advising on the role of patient organisations in clinical trials (www.patientpartner-europe.eu). The project’s main goals are:

• to make inventories of:
  • the needs of patient organisations regarding their involvement in clinical research;
  • the needs and expectations of other involved stakeholders;
• to identify and realise common points of action amongst all stakeholders through engaging in an active dialogue;
• to realise a European Network of Patients partnering in Clinical Research (ENPCR) to support the projects’ goals with their advice and to create a European network for interaction with the other stakeholders in the clinical trial field;
• to create European, patient-centred guiding tools and recommendations on how to create a successful partnership in the clinical trials context.

After the first Central PatientPartner Workshop in Brussels (11 June 2009), three two-day Regional Workshops are organised in three European regions:

• a North-Western European Workshop (12 and 13 October 2009, London, United Kingdom),
• a Central and Eastern European Workshop (30 November and 1 December 2009, Budapest, Hungary),
• a Southern European Workshop, and (24 and 25 March 2010, Athens, Greece).

These three regional workshops are meant for dialogue on regional-specific opportunities and hurdles towards more partnership in clinical trials, for example in relation to access to information, patients’ rights, cultural and political aspects, relationship between the various stakeholders, etc. Your input as stakeholders is of a key importance, not only for these workshops but also for the implementation of the project’s results in your own region in the near future.

The information gained from the workshops and throughout the project will play an important part in creating recommendations for more and better patient partnership in the clinical trial process. The resulting recommendations will be further discussed and developed during a Final Central Workshop (Brussels, 2010). In the third and final year of the project (2010-2011) the recommendations will be worked out further and then addressed to key European stakeholders such as regulatory bodies, academia, industry, policy makers, patient organisations, etc.

The Southern European Workshop, the last of the three (24 and 25 March 2010), will bring together stakeholders knowledgeable about the situation in Cyprus, France, Greece, Italy, Malta, Portugal, Spain and also Andorra, Gibraltar, Monaco, San Marino, Turkey, Vatican.

There will be three break-out sessions throughout the workshop.

• The first break-out session will focus on what role the Patient Organisations want to play and the areas in which Industry and Investigators find Patient Organisation participation desirable.
• The second break-out session will focus on what would need to be done in order for Patient Organisations and other clinical trial stakeholders to become partners.
• The third break-out session will focus on what the ideal world would be concerning a partnership in clinical trials, taking into consideration regionally different expectations, and what the Partners are willing to do in order to achieve this.

This 3-year project is funded by the EU Seventh Framework Programme (FP7) and operated by a consortium consisting of the Dutch Genetic Alliance (VSOP, project coordinator), the European Forum for Good Clinical Practice (EFGCP), the European Genetic Alliances’ Network (EGAN) and the Genetic Interest Group (GIG).