Dutch CF Trial Consortium
Background
CF centres in the Netherlands cooperate in clinical studies by sharing facilities and volunteers. Since December 2019 this collaboration is formalised in the Dutch CF Trial Consortium (NCFTC). The NCFTC consists all Dutch CF centers and us, the Dutch CF Foundation (NCFS).
Our successes so far
- Feasibility requests from two new sponsors
- Feasibility requests for all CF centers
- Patient referrals
- Actively reaching out to sponsors and institutions
- Central budget negotiation
- Central ethical committee submission
What we do
Cooperating in all CF clinical studies. Our aims:
- Maximal opportunities for people with CF to attend clinical studies
- Efficient use of dedicated CF staff, facilities and time
- One point of contact for interested external parties to investigate the feasibility of a clinical CF study in the Netherlands
How we are organized
The NCFTC steering group determines the policy, and the operational work is done by the Clinical Trial Facility (CTF). The CTF includes research coordinators and/or PI’s of all Dutch CF centers, a member of the NCFS and the consortium coordinator.
All external communication for companies, sponsors and investigators goes via the consortium coordinator (cftrialconsortium@ncfs.nl). Please read our charter for more information (click the orange words ‘Lees meer’ below)
Charter
The Dutch CF Trial Consortium (NCFTC) has been established in November 2019, aiming to perform all clinical CF trials in the Netherlands via this collaboration.
Why
- Maximal opportunities for people with CF to attend clinical studies
- Efficient use of dedicated CF staff, facilities and time
- One point of contact for interested external parties to investigate the feasibility of a clinical CF
study in the Netherlands
What
The consortium consists of all CF centers in the Netherlands for collaboration in CF clinical trials
Who
The consortium consists of a Steering Group and a Clinical Trial Facility (CTF). Members of the Steering Group are physicians from each adult and children’s CF center in the Netherlands, the research coordinators, two members of the Dutch CF Foundation (NCFS) and a NCFTC coordinator.
List of the hospitals:
– Academic Medical Centre Amsterdam
– Erasmus Medical Centre Rotterdam
– Haga hospital The Hague
– Maastricht University Medical Centre
– Radboud University Medical Centre Nijmegen
– University Medical Centre Groningen
– University Medical Centre Utrecht
The CTF is the executive body of the consortium. The CTF is a small committee with one research coordinator or physician from each of the seven hospitals, plus a chairman, plus one member of the NCFS, plus the coordinator of the NCFTC.
How
The consortium strives for a general agreement with a sponsor for feasibility requests. Per study, the sponsor indicates the desired number of centers. The feasibility request will be distributed via the coordinator. The consortium will decide which center(s) would be able to perform the trial and which center(s) would refer patients. Procedures have to take place within agreed timelines as recorded in Standard Operating Procedures. All participating centers have best efforts obligation. The budget negotiation will be done by one member of the CTF for all centers.
Governance
The Steering Group is the board and decides about finances, goals and overall progress. The Steering Group is directing the CTF.
The CTF coordinates the feasibility and trial enrollment. Daily tasks are performed by the NCFTC coordinator in agreement with CTF. The coordinator is the point of contact for external parties.
Centers are responsible for patient care and execution of clinical trials according to existing laws and regulations. For the consortium agreement between the centers the Dutch law is applicable. If a trial will be executed separate contracts have to be signed between each center and the sponsor.
