The ECFS –CTN will be a network in which independent CF Centres that fulfil a certain set of criteria (number of patients, human resources, track record in clinical trials and infrastructure support) voluntarily forming an alliance.

In a first wave, a limited number of sites will constitute the network. This will allow the network to pilot working practices, ethical approval, standard operating procedures and interaction with sponsors. In a second wave more centres will be able to join the network, the proposed timeline being in the 3^rd year after the start of the 1^st wave. All interested sites will be solicited to participate in phase III studies that require a large number of patients.

To select the most appropriate sites for the first wave of the network, an application form will be sent out to all centres which replied favorably to the first survey mentioned above. Centres that did not yet provide the second survey are supposed to send it in together with their application. Investigators from applicant- centres must be active ECFS members. The exact number of selected centres is not predefined (could depend on cut-of in ranking, geographic distribution and /or other opportunities) but the number will be deliberately small initially (about 10-15).

An Evaluation Board will be appointed by the ECFS-Board and will be responsible for the ranking of the received applications. The Evaluation Board will not include physicians from centres applying to participate in the network.

Criteria for centre selection will include

- Size: more than 75 patients in full care, either children or adults. Joint paediatric/adult centre application is strongly encouraged.

- Track record of clinical research (preferably phase II and phase III)

- Sufficient staff to run clinical trials efficiently and according to GCP

- Geographic distribution: at least 5 European countries but limit of 2 centres per country initially

- Clinical care according to ECFS Standards of care

- Commitment to recruiting sufficient patients for approved ECFS-CTN studies

- Time commitment from centre investigators for ECFS-CTN activities i.e. protocol review, ECFS-CTN meetings and telephone conferences, educational activities for non CTN CF Centres and other network activities

Procedure:
Candidate Centres are requested to fill in the Application form and send it back to the ECFS Office, Kastanieparken 7, 7470 Karup, Denmark, fax: +45 86 67 6290, email info@ecfsoc.org no later than March 25.

Download Application form