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CTN Newsletter - April 2012

 Year 4 Issue1

Introduction

At the start of 2012, the ECFS Clinical Trials Network has officially expanded from 18 to 30 sites and is now represented in 11 countries (Belgium, Czech Republic, Denmark, France, Germany, Italy, Portugal, Spain, Sweden, The Netherlands and UK). A complete list of CTN sites can be found here

The start of 2012 also means the ECFS-CTN is starting its 4th year of activities. At the steering committee meeting in January, we looked at our achievements from the past 3 years and have set the goals for the upcoming years. You can find a summary in this newsletter.

After 3 years, Kris De Boeck has finished her term as first CTN Director.  We all thank her for her extraordinary commitment! Long before the official start, she was closely involved with the preparations to setup the clinical trials network. It is mainly due to her skills, energy and intelligence that CTN is now well established after only 3 years as a key partner in cystic fibrosis clinical trials.

Kris will still be closely linked to the CTN as ECFS Board member, PI of the Leuven/Brussels site and with her involvement in several CTN activities.

 

A big thank you should also go to Steve Conway, for his valuable input as an Executive Committee member during the last 3 years!

Kris De Boeck
Kris De BoeckSteve Conway

Steve Conway

Isabelle Fajac from Paris is the CTN Director for the next 3 years.

Carlo Castellani  (Verona) will be co-chair for 1 year. 
Nico Derichs (Berlin), Pavel Drevinek (Prague) and Tim Lee (Leeds)
have joined the Executive Committee.

Carlo Castellani  Nico Derichs Pavel Drevinek Tim Lee

| Carlo Castellani   |    Nico Derichs   |    Pavel Drevinek   |    Tim Lee     |

  
 Isabelle Fajac
Isabelle Fajac

We also want to welcome Diana Bilton (London) as the new chair of the Networking Committee and Judy Bradley (Belfast) as the new chair of the Training Committee.

Diane Bilton  Judy Bradley

|  Diane Bilton  |  Judy Bradley  |

ECFS-CTN Steering Committee meeting in Bonn - 12-13 January 2012

Representatives from all CTN sites and committees met in Bonn for the winter meeting of the ECFS-CTN steering committee. The ECFS Patient Registry and representatives of European CF patient organisations organised meetings in parallel at the same location, which made this an excellent opportunity for the two groups to meet and to discuss common subjects and ways of cooperation.

The principal subject of the meeting was the presentation of the ECFS-CTN business plan for the next 3 years. A separate topic in this newsletter will discuss this in more detail.

We thank Mukoviszidose e. V. (the German CF association) for their logistic support of this meeting!

ECFS-CTN Business plan: 2012-2015

The aim of the ECFS-CTN is to strengthen the clinical research in the field of CF in terms of quality and quantity to ensure people with CF in Europe and beyond have access to effective treatment as quickly as possible.

Achievements 2009-2011 (based on initial goals)

Establish a first wave network of approximately 10-15 CF centres and expand it later:

In 2008, 18 sites in 8 countries were selected to form the ECFS-Clinical Trials Network. Basic structures and procedures were established within this group in the first 3 years. In 2011, 12 additional sites were selected to join the original group by 2012.

Establish a management structure for ECFS–CTN:

An organogram has been worked out that represents the interactions between the most important groups and partners. The executive committee meets every two weeks by teleconference and the steering committee meets twice a year face to face.

Reach 3-5 clinical trials per year

Since beginning of 2009, the ECFS-CTN protocol review committee has reviewed 22 study protocols.

Gradually, more and more studies become active in CTN sites (see graph).

At the end of 2011, 8 different clinical trials were active in CTN sites.

More details on active and finished clinical trials in CTN sites can be found here

  Protocol Graph

ECFS-CTN Business plan: 2012-2015

The ECFS-CTN will have run at least one Investigator-Initiated-Trial.

A list of possible topics has been created and protocol outlines are currently being drafted for 2 subjects that scored highest for priority and interest. These will be evaluated at the next steering committee meeting in June and the project with the most potential will be selected.

The ECFS-CTN will have continued to run CF clinical trials while improving quality within all CTN sites. ECFS-CTN will have adapted its structures and resources accordingly.

The monitoring of sites for certain performance metrics will continue and an electronic quality improvement platform will be setup in cooperation with the CFF-TDN.

The ECFS-CTN will have reached a consensus on LCI and chest CT procedures and will have provided an evidence-based proposal for LCI and chest CT to be used as surrogate endpoints for clinical trials.

These are projects that have already started, but that will be worked out further in the next 3 years. Cooperation with regulatory authorities and the pharma industry will be very important here.

The ECFS-CTN will continue to develop links with the patient-organisations, national networks, CFF-TDN and relevant international networks.

With the help of CF Europe and national patient organisations, trained patient representatives will be involved in the protocol review process. Patient organisations will also be invited to discuss research prioritisation for investigator initiated trials and measures to promote the participation of patients in clinical trials.

The ECFS-CTN Patient Brochure on clinical trials is now available in 10 languages

This brochure explains how a new drug is developed and how patients can help research advance as rapidly and safely as possible. The brochure has been specifically written for clinical trials in CF. These are the topics and questions handled:
Types of drugs
What is a clinical trial, what are the aims?
What is the process for development of a new drug?
Why are children also involved in clinical trials?
How is voluntary participation guaranteed?
How is safety monitored?
What will be asked of me when I am participating in a trial?
What should people consider before participating in a trial?
What is the role of the European Cystic Fibrosis Society – Clinical Trials Network (ECFS-CTN)?
What do I have to do if I want to participate in a clinical trial? How can I find out about upcoming and ongoing clinical trials?
With the help of national patient organizations, research coordinators and other volunteers, the brochure is now available in 10 languages!
Czech-Dutch-English-Flemish-French-German-Italian-Portuguese-Spanish-Swedish - available here


Annual Workshop of the European Network of Paediatric Research (Enpr-EMA),

and Meeting of the Enpr-EMA Coordinating Group (EMA London, 22-23 March 2012)

The European Network of Paediatric Research at the EMA (Enpr-EMA) aims to facilitate studies in order to increase availability of medicinal products authorised for use in the paediatric population. They seek to encourage the development of research networks in each paediatric speciality.  More information can be found here.
This group is very important for ECFS-CTN to be involved with (we are a voting member of the Enpr-EMA coordinating group) as it seeks to improve early communication between pharma, expert networks (e.g. ECFS-CTN), and the European regulators.  Thanks to the strong support of ECFS and the hard work and enthusiasm of those who have driven the development of ECFS-CTN we are seen as “an example of excellence” and many other areas (e.g. paediatric diabetes, endocrine, paediatric gastroenterology, paediatric cardiology) are seeking to follow our lead. In many cases they are struggling to harness the support and enthusiasm of their learned societies and all were very impressed by the vision and leadership and support of ECFS to ECFS-CTN. In addition the involvement and financial commitment of the CF patient organisations to ECFS-CTN was highlighted as a great strength.

Some key points related to this collaboration.

1. It is in the interests of everybody (Patients, Pharma, EMA, CTNs) that there is more specialist CTN involvement early in study protocol development, before submission to the regulators, because after regulatory approval things are already set in stone. Enpr-EMA wants to facilitate and drive this. Young people and their parents must be involved in how the paediatric CTNs run. So in CF we aim to involve parents and children with CF as well as adult patients with protocol review, feasibility assessments, design of information leaflets and assent/consent forms.

2. Collaboration between specialist networks, Pharma, and the EMA is needed to know what is coming up and to identify priority areas for clinical trials
Dr. Tim Lee (ECFS-CTN Executive Committee)

ERS Research Seminar ‘Preparing for the first early pulmonary intervention studies in infants and preschool children with CF’: A great success!

The seminar, organised by the ERS and with support of the CFF and the ECFS, took place in sunny Rotterdam on the 23rd and 24th of March. Over 60 participants, from all over the world gathered for two days to discuss how to facilitate multinational, multicentre intervention studies in newborn infants with CF. One of the participants was Preston Campbell (Executive Vice President for Medical Affairs of the CFF), underlining the significance of the meeting. Surrogate outcome measures that were discussed were: computed tomography (CT); bronchoalveolar lavage (BAL); and infant pulmonary function tests (iPFT). The aim was to come to conclusions on how we would use outcome measures in studies starting today.

On the first day state of the art presentations were given followed by lively discussions. These discussions were seamlessly continued during beer and dinner. On the second day participants were divided over 3 workshops to discuss various issues related to CT, BAL and iPFT.  From the start to the end of the seminar, participants remained remarkably focused to accomplish the goal of the meeting. Currently a manuscript is being prepared to summarise the outcome of the seminar. This manuscript will give guidance for clinical studies that are in preparation. The seminar underlined the eagerness of the CF community to do interventional studies in infants with CF. How to do them has now been defined. Now, let’s do them!

Prof. Dr. Harm Tiddens and Prof. Dr. Steve Stick
Participants at the ERS Research Seminar Rotterdam
Participants at the ERS Research Seminar, Rotterdam

 


ECFS-CTN Newsletters

Year 4 Issue 1 - Newsletter - Apr 2012 (pdf)
Year 3 Issue 2 - Newsletter - Oct 2011 (pdf)
Year 3 Issue 1 - Newsletter - Mar 2011 (pdf)
Year 2 Issue 1 - Newsletter - Sep 2010 (pdf)
Year 1 Issue 2 - Newsletter - Dec 2009 (pdf)
Year 1 Issue 1 - Newsletter - May 2009 (pdf)