6 -Public Involvement
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
ECFS-CTN - European Cystic Fibrosis Society - Clinical Trials Network |
|
| Involvement of patients, parents or their organisations in the protocol design | Yes | All protocols are reviewed by a review committee including 2 patient / family reviewers. Protocol acceptance for the network sites is voted in executive committee that includes 1 patient organizaton representative. |
| Involvement of patients, parents or their organisations in creating the protocol info package | Yes | Study specific protocol information package is designed by pharma company. General information packages on clinical trials have been developed with input from patient organizatons (brochure on clinical trials, childrens leaflet on clinical trials, posters "where does my current medication come from" See https://www.ecfs.eu/ctn/patient-brochures https://www.ecfs.eu/ctn/brochure-children https://www.ecfs.eu/ctn/my-current-medication |
| Involvement of patients, parents or their organisations in prioritisation of needs for Clinical Trials | Yes | Patients and a patient organization representative are involved in protocol review including assessment of strategic fit/ priority scoring. Sites and patients regularly participate in priority setting exercises, e.g. the recent James Lind alliance priority setting exercise. |