last updated 21 April, 2008

Prospective Clinical Trials in the EBMT

The PCTC's remit it to provide guidance and support to the clinical trials programme, whilst ensuring that the operational resources are in place prior to the initiation of any study. The committee is comprised of a Chair (who is a Haematologist), the Director of Clinical Trials Operations, the PCTC Administrator, a Statistician and four Haematologists.

The primary scientific impetus, for the adoption of any new protocol, is from the working parties. They are charged with the responsibility of identifying the research priorities that best meet both clinical need and the scientific goals for each disease area.

The role of the PCTC is to expedite the internal and external review of the protocols proposed by the working parties and oversee the allocation of operational resources. In the case of purely academic studies with limited or no funding opportunities, the PCTC will make recommendations to the board on prioritisation; such recommendations will be driven by the scientific goals and strategy of the EBMT as a whole and evaluation of the operational resources available to support non/under funded research.

Clinical Trials in the EBMT


From the date of inception the EBMT has succeeded in binding together the similar interests of transplant centres throughout Europe. The combination of scientific expertise and access to the wealth of data in the Registry database has provided the EBMT with an excellent scientific foundation for the development of study protocols. To complement the scientific strengths of the group, significant investment in the clinical trials infrastructure has now provided a robust operational support structure.

There are many challenges to running pan European studies, not the least of which is language. There are three clinical trials offices within the group, based in London, Leiden and Paris. Historically, these developed as the working parties that led the development of clinical trials were based in these cities, lymphoma, (London), chronic leukaemia (Leiden), acute leukaemia (Paris). These offices will be maintained, to provide a multi-national, multi-lingual group to manage clinical trials operations across all the working parties. Part of the on-going development includes the establishment of a team of monitors, who will be based in EBMT institutions. This will ensure that the monitors have both the linguistic and clinical skills necessary to function across all the member countries of the EBMT and all therapeutic areas.

The operational workforce has been strengthened by the appointment of additional data managers/trial coordinators and recently the first EBMT trials monitor, based in Germany. Another 2 monitors should be in post in the next few months, the first based in France. Within the next 2 years it is anticipated that there will be dedicated EBMT monitors in all major countries of the EBMT.

In addition a new post has been created, that of Director, Clinical Trials Operations. The remit of this post is to undertake direct management of all prospective clinical trials staff to facilitate the development of a cohesive, multi-national group to provide all the developmental and operational support of clinical trial conduct. The Director also functions as the primary liaison with the pharmaceutical industry.

The expertise provided by the EBMT's clinical trials personnel includes:

• Development of protocols
• Database management and trial coordination
• Contract negotiation
• Design and implementation of case record forms
• Monitoring
• Translation
• Standard Operating Procedures (SOPs) development
• Training

For further information please contact:

Kim Champion
Clinical Trials Operations Manager
12th Floor
Guy's Tower
Guy's Hospital
St Thomas Street
London SE1 9RT
United Kingdom

kim.champion@kcl.ac.uk
Phone: 44 207 188 8402
Fax: 44 207 188 8406