CTN Newsletter - November 2013

Update on CTN studies and reviews

- Update on CTN studies and reviews

- CTN Steering Committee meeting Lisbon, June 2013

- Training day Lisbon, June 2013

- Support from European National CF Associations

- CTN Service for Clinical Trial feasibility checks

- ECFS-CTN visits the CFF-TDN

- Information for people with CF on the ECFS-CTN website

15 studies are currently ongoing in ECFS-CTN sites.

The CTN website includes the status of all studies currently recruiting patients and the results of finished studies when they become available and can be found here

7 new study protocols have been reviewed so far in 2013. Most of these studies are expected to start in 2014.

Representatives from each CTN site, patient organization delegates and leaders of specific working groups met at the ECFS conference in Lisbon, for a face to face Steering Committee meeting (organized twice a year).

One of the major current themes is "quality".  

Quality within CTN sites has been assessed regarding both site performance in clinical trials (2012 data) and site communication with the coordinating centre (data from the last 6 months). All sites received an individual evaluation report and this process will be repeated regularly. This assessment data will provide an evolution of site performance which can be evaluated for any steps that may need to be taken.

Five ECFS-CTN pilot sites explored the “eQUIP-CR” online program to assess and improve quality related to the conduct of CF clinical trials. This program has been developed by the CFF-TDN for the clinical trial sites in the US and has been made available for ECFS-CTN sites.

Standardization and certification processes are ongoing for measurement of Nasal Potential Difference, Lung Clearance Index and for chest CT scans. Companies that are interested to use these outcome parameters in clinical trials are advised to contact the ECFS-CTN early in the study setup process.

Group photo from the June 2013 Lisbon meeting

The yearly ECFS-CTN training day at the ECFS conference was attended by 23 Investigators and 33 Research Coordinators.

Colleen Dunn and Zoë Davies, research coordinators at the TDN, presented topics on informed consent and on the responsibilities of the research team.

Updates were given on the eQUIP-CR quality improvement program and on Lung Clearance Index as an outcome parameter.

During the second part of the morning session, interactive workshops were organized on the following subjects:

o     Translation of drugs from research into practice
o     Budget issues
o     Challenges of new CTN sites
o     How to deal with competitive recruitment

The afternoon was dedicated to a protocol review training session for research coordinators and study nurses. They were provided instruction on the general purpose of protocol review and learned to identify the parts of the protocol  that benefit most from their review and comments, such as the flowchart of study procedures, and other parts related to the feasibility of the study conduct at the site.

Patient reviewers were trained earlier in 2013 and each protocol review now involves 2 patient reviewers.

At the 2013 Lisbon conference, European National CF Associations presented  their continued support towards the ECFS Clinical Trials Network. A cheque of 125.000€ was handed over to the ECFS President Stuart Elborn, and CTN Director Isabelle Fajac.

BE - vzw Mucovereniging/Association Muco asbl
FR - Vaincre la Mucoviscidose
GE - Mukoviszidose e.V.
IT - Lega Italiana Fibrosi Cistica Onlus (LIFC)
NL - Nederlandse Cystic Fibrosis Stichting (NCFS)
CH - CFCH
UK - CF Trust 

Feasibility questionnaires are used by study sponsors to make decisions on site selection and investments.

Important feasibility aspects are:

• The site is qualified (personal, experience, equipment, time,…)
• The site is interested (supports the research question and the protocol, has not conflicting studies)
• The site has sufficient patients meeting the protocol criteria AND willing to participate.

It is the responsibility of the Investigator to provide realistic information, but shortfalls in information create some difficulties for the sites:

• Requests are often anonymous (no sponsor mentioned and minimal study information provided)
• Sponsor is known but no full protocol is provided
• Questionnaires are received from several  Contract Research Organizations (CRO’s) about the same (anonymous) protocol
• The time needed by the site personnel to provide correct information is underestimated by the sponsor or CRO.
• The questionnaire contains irrelevant questions, or is asking for unnecessary details
• Sites have to provide feasibility information before the protocol has been reviewed by the ECFS-CTN

ECFS-CTN sites have agreed on a standardized procedure on how to handle feasibility requests coming from sponsors and CRO’s,  related to multinational, multicenter clinical trials.

Sites will refer requests for feasibility information to the ECFS-CTN, who will setup an agreement with the company and coordinate the feasibility service. So far this service  has been completed 8 times, and more are planned for upcoming studies. 6 different companies have been involved so far.

This brings several advantages to the sponsor:

• The ECFS-CTN has all expertise on board related to this specific rare disease
• ECFS-CTN experts can pro-actively review the questionnaire and suggest changes, making the questionnaire more acceptable to investigators
• The ECFS-CTN coordinating centre is aware of the study load of the sites and can provide central advice on country and site selection regarding certain aspects
• Sites will be responsive once they know the feasibility service is supported by the ECFS-CTN
• The coordinating centre is in close contact with the sites for follow-up on responses
• The sites are encouraged to provide realistic information
• The feasibility check is aligned with the ECFS-CTN  protocol review

Companies are advised to contact ECFS-CTN early in the process (ecfs-ctn@uzleuven.be), so the service can be setup pro-actively and a communication plan can be setup between the sponsor, CRO and the ECFS-CTN.

In April, the ECFS-CTN Director, Isabelle Fajac, and the Head of the Training Committee, Judy Bradley, went to Seattle to visit the CFF-TDN for a couple of days. The topics discussed were the quality assessment within the TDN, the quality improvement program (EQUIP-CR) and the TDN resources for investigator-initiated trials.

Jill Van Dalfsen and George Retsch-Bogart were there as well as Colleen Dunn, Natalie Beauchene, Jean Kirihara, Leila Atry and many others. It was an excellent opportunity to exchange and discuss specificities and similarities of practices in US and Europe.

Natalie Beauchene, George Retsch-Bogart, Colleen Dunn, Judy Bradley, Jean Kirihara, Jill Van Dalfsen, Isabelle Fajac

The ECFS-CTN has been actively developing different materials with information for patients related to clinical trials and the development of medicines:

• Information brochure on clinical trials in cystic fibrosis
• Children’s leaflet on cystic fibrosis research
• Posters: “where does my current medication come from”

These documents have been translated into different European languages and have now been grouped into 1 section on the ECFS-CTN website https://www.ecfs.eu/ctn: “Information for People with CF”.

A separate chapter on the website shows the links for trials that are currently ongoing in CTN sites:
https://www.ecfs.eu/ctn/clinical-trials