Eurordis is proud to introduce its Charter for Collaboration between Sponsors and Patient Organisations for Clinical Trials in Rare Diseases. For the diseases we represent, patients are rare, and so is expertise; knowledge and funding are limited. Thus, to pool these rare and valuable resources and optimise their use in rare disease clinical trials, a partnership between interested parties is the only reasonable approach. Bringing patient organisation representatives to the heart of the drug regulatory decision making process was a major step forward for Europe. Enhancing the dialogue between sponsors and patient organisations in rare disease clinical trials is a necessary next step. The Charter and its accompanying tools have been developed to that end.

This Eurordis Charter is part of larger endeavours: one of them is the training by Eurordis of patient representatives in reading and understanding clinical trial protocols, and contributing to their improvement; another initiative is the workshops organised every six months by Eurordis, with representatives of companies, regulators and patients. May all our partners in these new initiatives be warmly thanked: EMEA, COMP, European Commission, INSERM, Leem, members of the Eurordis Round Table of Companies, AFM- Téléthon, and all the members of the Eurordis network involved in these projects.

Yann Le Cam
Chief Executive Officer

A new tool for rare disease clinical trials was introduced in January 2007, with the launch of the Eurordis Charter for Collaboration between Sponsors and Patient Organisations for Clinical Trials in Rare Diseases. The Charter is issued from in- depth discussions on how to promote good practices. It aims at improving the quality of clinical research in rare diseases and at enhancing a transparent and effective dialogue between sponsors and patient organisations.

The first Spanish Rare Disease Awareness Week, coordinated by FEDER, took place on 20-27 October 2006. Rare disease patients, the industry, the government, media and patient organisations participated in various activities aimed at increasing awareness on rare diseases and raising funds. To say it was a success is an understatement. This article gives an overview of the Week’s activities and of the results and lessons learned.

The New Zealand Organisation for Rare Disorders (NZORD) is a charitable trust dedicated to providing information on rare diseases to patients and their families, promoting research, and building partnerships between patients, clinicians, researchers, government and industry, to improve diagnosis, clinical care and social supports. It became an associate member of Eurordis in December 2006.

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Editorial Team: Yann Le Cam, Jérôme Parisse-Brassens (Editor and Writer), Julia Fitzgerald, Nathacha Appanah (Writer), David Oziel (Site of the Month), Anja Helm, François Houÿez, Flaminia Macchia

Translation Team: Conchi Casas Jorde (Spanish), Ana Cláudia Jorge and Victor Ferreira (Portuguese), Roberta Ruotolo (Italian), Trado Verso (French), Ulrich Langenbeck (German)