European Cystic Fibrosis Society

Year 1 - Issue 1

Dear colleagues and friends in the CF field, Dear partners in industry

With this newsletter we want to provide a short update on the ECFS-Clinical Trial Network. Eighteen centres from 8 European countries from as far north as Sweden, to as far south as Portugal work together in this CF specific research network. In this newsletter we provide a full list of all with their respective principal investigators and co-investigators. However to work with or enquire about our network we ask you to mail, fax or phone the coordinator or director at the coordinating centre in Belgium.

Following several preparatory meetings, the ‘founding meeting’ with all partners involved took place in the autumn of 2008. There all partners agreed on the aim of the network of promoting efficient and high quality research in CF. The necessary structures were defined and an Executive Committee was nominated that, besides myself as chair and Harm Tiddens as co-chair, comprises Steve Conway (UK), Isabelle Fajac (France), Thomas Wagner (Germany) and Franck Dufour (France) as representative of the European patient/parent organisations. We meet twice a month by way of teleconference and have devoted our time to implementing the policy we have all agreed on and that was laid down in our ‘code of conduct’. An important task has been the recruitment of a Coordinator. After interviewing several valuable candidates, Mrs Veerle Bulteel was selected. We hope that you will have the chance to meet this ‘key person’ in Brest.

Another main task of the Executive Committee has been to make the working groups take shape. The Protocol Review Committee will be led by Harm Tiddens with the help of Raphael Chiron (France). The Standardisation Committee which will insure high quality standard operating procedures will be led by Isabelle Sermet (France). It will comprise several sub-committees: Respiratory Function Explorations , Lung Imaging, Microbiological Explorations, Inflammatory Markers, Nutritional status evaluation and Nasal Potential Difference. Several of you have taken on the challenge of leading the subcommittees (we will present a full list in the next Newsletter).

The Training Committee which will build further research expertise in the different centres will be led by Tim Lee (UK). The Data Safety Monitoring Board will be led by Behrouz Kassai (France) and the Networking Committee by Alan Smyth (UK). We will also invite researchers from non CTN centres to join these working groups since we need as much expertise as possible and since the aim is to enlarge the network in due time. I want to thank you all for your active participation and willingness to give your expertise and time for these working groups. This will allow CTN to move forward with efficiency.

We realise that the CF patients and parents will play a crucial role in the success of the network. With the help of Franck Dufour, the Executive Committee has written a letter to patient organisations to ask for their active input and to promote patient participation. A positive feedback and an active implication of patient organisations are expected when clinical trials are ready to start through the network. A regular newsletter to the patients will keep this important channel of information very active.

The Executive Committee has had interactions with EMEA and with other networks, especially the American Therapeutic Development Network, the CFF-TDN. We want to learn from the best! From the beginning, our network has had good communication with the CFF-TDN, and this is now strengthened by regular teleconferences between Harm Tiddens and the TDN. We are happy to have TDN’s full support.

Finally and importantly, the Executive Committee has informed the pharmaceutical Industry of the procedures to follow to submit a clinical trial to the network. Information can be found under the links on the left. Several protocols have already been submitted. To start with, they were reviewed by the Executive Committee; they are now taken care of by the Protocol Review Committee. The first study is up and running in Germany, UK, France, Netherlands, Belgium.

Kris de Boeck and H Tiddens, Chair and Co-chair
And the CTN Executive Committee members