The participation of patients to the NECESSITY Project from European Sjögren’s Syndrome organizations and, also, from other organizations worldwide will be done through a Patient Advisory Group (PAG).
The PAG will receive patient input from the organizations on unmet needs and will report them to the NECESSITY Team so that the Project is in line with the patients’ point of view.
The most critical point will be when the proposed outcome measures and composite measure have been formulated but not finalized. The PAG will also be able to update their own members regarding the clinical trial, its progress and opportunities for patients to participate if they wish to do so. Members of the PAG offer a route to identify suitable individuals to provide patient input to Workpackages 5, 6, 8, 9 and 10.
The PAG will disseminate information about the Project results to the patients, their families and the public for them to be aware of the last research findings. The members are from European organizations where the clinical trial will take place and from the American organization because the patients’ reported outcomes will be needed by the FDA.