Year 1 Issue 2 - Newsletter - Dec 2009
Dear Colleagues and Friends in the CF field,
Introduction
We are pleased to provide you with an update on the European Cystic Fibrosis Society Clinical Trials Network (ECFS-CTN) in this second newsletter. Please note you can always check our webpage (http://www.ecfs.eu/ecfs_supported_initiatives/ecfs_clinical_trials_network), to read a general introduction about ECFS-CTN, or to find newsletters from the past. Also, an information letter to companies is posted there to inform the pharmaceutical industry about the procedures for submitting a clinical trial to the network. For all inquiries, please do not hesitate to contact the coordinating centre in Belgium. In brief, this research network for Cystic Fibrosis was founded in the Autumn of 2008 as a working group of the European Cystic Fibrosis Society (ECFS). The main aim is to promote efficient and high quality research in CF.
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The network consists of 18 centers from 8 European countries. Different working committees have been established and, as described below, are actively developing their role. In this newsletter, we will focus on the role of the Coordination Center, and on the activities of the Protocol Review Committee and the Standardization Committee.
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CTN Coordination Centre
| In May 2009, a network coordinator (Veerle Bulteel, located in Leuven, Belgium) was appointed to act as a central point of contact and to streamline communication between CTN sites, working groups, patient and parent organizations, industrial companies, etc. | |
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The coordination center follows up on the decisions and action items generated by the executive committee and other working groups, and coordinates the protocol review process. To get acquainted with the specific world of CF research, Veerle followed clinical activities in the CF centers of Leuven and Rotterdam, participated to the ECFS conference in Brest and visited the Mukoviszidose Institute in Bonn, Germany. She also traveled to Seattle to learn about the activities of CFF-TDN (Cystic Fibrosis Foundation – Therapeutic Development Network), which is the US counterpart of ECFS-CTN. In June, at the ECFS conference in Brest, the CTN steering group held their half yearly meeting (the next meeting will be held end of January 2010 in Leuven). The committees for training, standardization and networking took the opportunity to meet face to face. During the conference many contacts were established with people from national networks, patient organizations and pharmaceutical companies. |
 From Left to Right: Els Aergeerts (CTN Secretary) Kris De Boeck (CTN Director) Veerle Bulteel (CTN Coordinator) ECFS-CTN@uzleuven.be |
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Protocol Review
One way of achieving high quality clinical trials is through the review of study protocols by the CTN Protocol Review Committee. The review process is one of the core activities of the CTN. Companies are invited to involve the CTN in the early stage of their protocol development. Detailed feedback about the study design is provided and a score is calculated that indicates the priority of the protocol for acceptance into the network. The protocol review process has been based on the model used by TDN in the USA and has only been modified where needed to adapt to the European situation. The CTN coordinator overviews the process and timelines from the first contact with a company, until delivery of the final report and follow-up communications. A plan has been setup with the TDN, for the provision of global reviews and a global Data Safety Monitoring Board (DSMB), as this has been a specific request by some companies. Also the web tool from the TDN that allows for online protocol review will be made available to the CTN.
As of October 2009, six protocol reviews have been completed. In addition, the CTN is currently collaborating with a leading biopharmaceutical company to assist in the design of their research strategy in Europe. The goal is to combine high quality scientific design with a realistic study scheme and in- and exclusion criteria. This will also help to optimize recruitment in sites.
Standardization
As promised in the first newsletter, we can now provide the list of chair persons leading the different standardization subcommittees (see Appendix).
The standardization subcommittees for Lung function, Microbiology, Inflammatory Markers, Imaging, Nutrition and Electrophysiology (NPD / ICM / Sweat test) have started preparations to write a consensus document on outcome parameters. The subcommittees will work together with their counterparts in the USA (TDN reference centers). A consensus meeting will be organized for March 2010.
The main goals of the consensus will be to document the current agreements on outcome parameters in clinical trials (inside and outside of the CTN), to compose a literature inventory, and to establish standard operating procedures. The document will also offer some guidance to the EMEA.
Appendix: Chairs of standardization committees:
Inflammatory markers:
Lieven Dupont, Leuven, Belgium
Michael Fayon, Bordeaux, France
Lung Imaging:
Marcel Van Straten, Rotterdam, Netherlands
Keith Brownlee, Leeds, UK
Microbiological explorations:
Miles Denton, Leeds, UK
Giovanni Taccetti, Firenze, Italy
NPD:
Isabelle Sermet, Paris, France
Inez Bronsveld, Utrecht, Netherlands
ICM:
Martin Hug, Freiburg, Germany
Hugo De Jonge, Rotterdam, Netherlands
Sweat Testing:
Kevin Southern, Liverpool, UK
Nutritional Evaluation:
Marco Cipolli, Verona, Italy
Anne Munck, Paris, France
Allison Morton, Leeds, UK
Respiratory Functions:
Philippe Reix, Lyon, France
Stefan Zielen, Frankfurt, Germany
A big thank you
- To the ECFS Board, for supporting the CTN.
- To the CFF-TDN, for their maximal cooperation.
- To the CTN PI’s and their staff, for their involvement and work in the CTN committees.
- To the patients, for their participation in clinical trials in the past, now and in the future.
ECFS-CTN Newsletters
Year 1 Issue 2 - Newsletter - Dec 2009 (pdf)
Year 1 Issue 1 - Newsletter - May 2009 (pdf)