Information to Industry Partners

To whom it may concern,

The European Cystic Fibrosis Society has formed a Clinical Trial Network (ECFS-CTN). The aim of the ECFS-CTN is to increase the quality and quantity of CF clinical research by realizing efficient and high quality clinical trials. The network provides access to large and experienced CF centres throughout Europe. 43 sites in 15 countries, caring for a total of 17.500 CF patients are part of the ECFS-CTN.  All centres have ample experience in clinical research.

The CF research community and the CF patient and parent organisations are pleased that, at last, many drugs are on the horizon with the potential to improve the treatment of patients with CF. These include drugs aimed at restoring protein function, ion transport and epithelial hydration that may prove disease modifying, antibiotics to provide efficient and more patient friendly treatment of lung disease as well as drugs aimed at other aspects of the complex multi system disease.

The ECFS–CTN will offer several services:

  • Access to a large number of patients, children and adults, with well characterized clinical phenotype and high standards of care
  • Quick feedback about the study design (phase 1, 2 or 3), the priority of the protocol in the network, the number of patients in the network clinics that meet the inclusion criteria
  • Preferential patient inclusion in protocols selected by the network
  • High standards of performance
  • Possible data safety monitoring board assistance
  • If needed, contact with CF specialists with expertise in specific domains, help in building the study design


Procedure

  • The planned clinical trial should be sent to the CTN-Director. The confidentiality agreement according to the template of the company should be sent to the CTN Director and will be signed by the Director and the members of the Protocol Review Committee.
  • The protocol will then be run through the Protocol Review Committee and the Priority Committee, and an answer regarding the study design, the priority score of the clinical trial and the number of patients that meet the eligibility criteria in the will be given within 6 weeks (fee for this service in attachment)
  • If the clinical trial is selected by the Network, it will run in the centres selected by joint agreement between the centre directors and the pharmaceutical company. CTN will facilitate patient recruitment, a smooth running of the study and high standards of performance.


The centres forming the CTN have agreed on this policy and will preferentially perform trials that are selected by the Network. The pharmaceutical company can be assured that high standards will be maintained in all centres.

The CTN is of course not a Contract Research Organisation (CRO). The running and follow up of the study remains in the hands of the pharmaceutical company and the CRO of their choice. 

The CTN has centres in Belgium, Czech Republic, Denmark, France, Germany, Italy, the Netherlands, Portugal, Spain, Sweden and UK.  It is possible that a company will not run a particular study in all countries included in the network. The CTN partners understand and accept this fact. Likewise a company is free to also include CF centres outside the ECFS-CTN or cooperate with existing national clinical trial networks.

We advice companies to start interaction with ECFS-CTN early, i.e. when the protocol is still in draft phase and before site selection has started.


Contact the ECFS CTN

For all further information or enquiry please contact the Director of ECFS-CTN at 
ECFS-CTN@uzleuven.be

We are sure that we will have a successful partnership.

The ECFS-CTN Executive Committee


Data Safety Monitoring Board

The ECFS-CTN can provide assistance for the setup of an independent Data Monitoring Safety Board with CF experts. 
This service is optional. 
The CTN will bring you in contact with the DSMB coordinators (based at the University of Lyon in France), who will setup an agreement, arrange the fees, and execute services independently. 
Please click here to see a brochure with additional information.
For global studies a global DSMB can be setup in cooperation with CFF-TDN.