EURORDIS Charter for Clinical Trials in Rare Diseases

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:

Beta Innov Boehrin Celgene CLS Behring
Johnson and Johnson Novartis Oncology Swedish Orphan International Takeda Pharmaceuticals Europe Ltd.


The collaboration spans several aspects of clinical trials:

  • Bibian Verstegen 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.

research into rare diseases | la recherche | la investigación en enfermedades raras | la ricerca | investigação | Forschung


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:




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

Page created: 19/08/2009
Page last updated: 23/05/2016
The voice of rare disease patients in EuropeEURORDIS The international voice of people living with rare diseases, Rare Diseases International is a EURORDIS initiativeRare Disease International Bringing together patients, families and experts to share experiences in a moderated multilanguage forum, RareConnect is a EURORDIS initiative RareConnect An international awareness raising campaign taking place on the last day of February each year, Rare Disease Day is a EURORDIS initiativeRare Disease Day Join the largest gathering of rare disease stakeholders across Europe, at the biennial European Conference on Rare Diseases and Orphan Products. ECRD is a EURORDIS initiativeEuropean Conference on Rare Diseases