In a knowledge-based society, both policy makers and citizens should be equipped to make informed choices from the ever-growing range of options thrown up by scientific and technological progress, states the EU Science and Society Work Programme for 2006. This is very true for European rare disease patients and patient organisations, who often wish to take part in research activities on their disease, but don’t know where to start or simply do not master the language used in research. The Capacity Building for Patient Organisations in Research Activities project (name code: CAPOIRA), funded by the European Commission for eighteen months, was set up to respond to these needs.
‘The CAPOIRA project will facilitate the creation of structural links to bring civil society and the scientific community closer together. Ultimately the goal is to create a common language and mutual understanding,’ says Shane Lynam, coordinator of the project at Eurordis. ‘The project involves five partners, out of which four patient organisations from different countries: Eurordis, the leader of the project; INSERM (Institut National de la Santé et de la Recherche Médicale - France), which co-organises the project with Eurordis; FEDER (Federación Española de Enfermedades Raras - Spain); UNIAMO (Federazione Italiana Malattie Rare - Italy); and RDD (Rare Disorders Denmark).’ The European Clinical Research Infrastructure Network (ECRIN) is closely associated to the project. The main idea is to foster the participation of patient organisations in research activities by increasing their knowledge, skills and capabilities in the two areas of clinical trials (private or public; at national or European level) and EU-funded health research projects (clinical or non-clinical). The project is built along two axes: ‘Understanding Clinical Trial Protocols’: six training sessions in three countries (Denmark, Italy, and Spain). ‘Gaining Access to Rare Disease Research Resources’: a two day European workshop in Paris, on 4/5 May 2007, organised at the same time and location as the Eurordis Membership Meeting 2007 Paris.
The training sessions on clinical trial protocols will be based on an improved version of a module previously developed by Eurordis and INSERM, and already successfully implemented in France (12 sessions for 160 patient representatives from 120 different patient groups in 2004-2005). The module aims at familiarising patients and patient representatives with the vocabulary, concepts and key issues of evidence-based medicine and clinical research. The sessions will be delivered by two trainers in the national languages. Participants will be selected by the national project partners, and half of them will have their expenses paid for.
For Yann Le Cam, the project leader of Capoira, ‘the ultimate goal is for patients and patient groups to become able to actively engage in EU-funded research projects and act as catalysts in the development of research on their own disease. It is also part of our efforts to place Eurordis patient representatives in the expert review panels for rare disease and genetic research grants of the European Commission.’
Both the national training sessions and the European workshop will be open to rare- and common- disease patients. Up to 15 people will participate in each national training session and 30 researchers will take part in the European workshop, on top of patients. Overall, at least 250 patient representatives from all over Europe will benefit from the national training sessions and the European workshop. These 250 patient representatives are in addition to 150 others who will participate in pilot training sessions organised by INSERM in France in 2007 on Patient databases and registries, Gene testing, and Finding validated medical information on the Web. These training sessions will be implemented throughout Europe at a later stage. Since 2004, more than 400 patient representatives have participated in training sessions organised by Eurordis1. ‘We are hoping that this project is only a stepping stone in the building of broader research capacity-building activities for patients and patient groups from all over Europe,’ says Fabrizia Bignami, in charge of coordinating the European workshop at Eurordis. ‘If the experience is successful, we are envisioning many more national training sessions and European workshops in the future. It is time patients are given the tools to build their own research agenda and start contributing concretely to research policy development in Europe.’
1Provision of information on clinical trials, European drug regulatory affairs, Finding validated medical information on the Web, and Patient databases and registries.