EURORDIS Charter for Clinical Trials in Rare Diseases

The Charter 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 "EURORDIS Charter for Collaboration between Sponsors and Patient Organisations for Clinical Trials in Rare Diseases" aims at improving the quality of clinical research in rare diseases and at enhancing a transparent and effective dialogue between sponsors and patient organisations.

Below are the companies who have already signed the Charter for Clinical Trials:

The collaboration spans several aspects of clinical trials:

• Adapting the design of the study to patients' expectations to facilitate their adhesion to the trial;
• Providing early information to potential participants to ensure and speed up their inclusion in the trial;
• Supporting patients during the study to reduce the number of drop-outs and incomplete files;
• Taking quality of life into consideration and discussing trial results with sponsors to contribute to the assessment of clinical and day-to-day benefits of the treatment.

The Charter also details what a written Agreement of Understanding between a clinical trial sponsor and a patient organisation should include for a given clinical trial.

EURORDIS offers to help clinical trial sponsors identify and contact relevant patient organisations, and to assist sponsors and patient organisations in setting up their collaboration.

For more information on the EURORDIS Charter for Collaboration for Clinical Trials in Rare Diseases:
Contact: anne-mary.bodin@eurordis.org

Author: EURORDIS
Graphics: © Eurordis
Photos: researcher © Pan American Health Organization ;
Bibian Verstegen © Jose Verstegen-Ruijs / Stichting voor AfweerStoornissen - (SAS)