Chair: Charles Craddock - Charles.Craddock@uhb.nhs.uk
Created in 2011
It is now largely well established that academic prospective clinical trials aimed at acquiring scientific knowledge, form a key part of patient-oriented clinical research, and create the basis for continuously improving patient care. This is particularly true in the field of stem cell transplantation (SCT), where studies deal with potential therapeutic innovations that do not necessary attract the pharmaceutical industry. Moreover, as treatment outcomes for many haematological diseases have progressively improved during the last years, it has become necessary to conduct larger and larger trials to demonstrate meaningful improvements in the standard of care.
With this background, the EBMT established a few years ago the CT2 Committee and the Clinical Trials Office (CTO), with the aim to allow for a pan EBMT commitment to opening and running some large prospective clinical trials.
1. Support the Board in its responsibility to decide about the relevance and feasibility of a CT proposals.
2. Advise the CT Office on its responsibility to manage the Clinical Trials Portfolio.
1. CT proposals assessment
2. Chair presents recommendation to board
3. Annual report to the board
4. Follow-up of CT portfolio
Charlie Craddock (chair)
Franco Locatelli (vice-chair)
Legal and Financial Advice
Clinical Trial Operations Advice and CT2 coordinator
All EBMT sponsored prospective clinical trials are run in line with the Declaration of Helsinki, ICH GCP and national and international regulations, including the EU Clinical Trials Directive (2001/20/EC) and the EU GCP directive (2005/28/EC).
Click here to read the guidance for investigators.
Chair: Myriam Labopin - firstname.lastname@example.org
Created in 2004
A major issue in clinical research is the choice of appropriate statistical methods. Methodological choices are crucial in all steps of a study, from the design, via data collection to the analysis and interpretation. The EBMT, as a scientific organization, actively promotes research on all aspects concerning hematopoietic stem cell transplantation. The statistical committee as such is not part of the EBMT management structure since it acts primarily as an advisory committee to other EBMT committees as well as the EBMT Board and the EBMT management; moreover it serves as a meeting place for “EBMT statisticians” to exchange views and knowledge and coordinate methodological activities.
1. To facilitate cooperation and information exchange between people actively involved in methodological aspects
2. To attempt a reasonable unification of approaches within EBMT as well as a uniform high level with respect to methodology being used and published in peer reviewed journals
3. To advise the Board or other EBMT committees on request about methodological issues concerning both the Registry and the Clinical Trials Office
4. To develop and divulge new statistical tools when necessary
1. Educational Courses (EBMT meeting & ESH courses)
2. Guidelines for statistical analysis of transplant data
3. Protocol review for the CTC
4. Active participation in the process of choosing any new data management system to safeguard its usefulness for statistical analyses.
Nuclear Accident Committee
Chair: Ray Powles - email@example.com
Created in 2003
The Committee was formed by the Board after 9/11 to address terrorist radiation incidents. The committee was created because there was no network worldwide in place to address the immediate medical consequences of a major accidental of terrorist radiation incident that may involve hundreds or thousands of victims. The EBMT led the way on it and has been followed by the US RITN.
To make the EBMT’s unique resource of 500 centres (networking into satellite hospitals) with skilled academic specialists and nurses throughout the EU, the central part of an infrastructure to deliver care to potentially thousands of patients.
1. Input into ongoing international Consensus meetings to optimize triage and treatment for victims; and defining bed configurations, and training of care workers, We give invited lecture on the International scene, produce reports and write papers.
2. Help other countries with infrastructure advice, and if a developing country has an incident we offer technical and infrastructure advise.
3. Developing a high profile in the UK preparedness for the Olympics: have found a bed configuration of 132 hospitals that can treat neutropenic patients, written a UK Guidance document and had five regional training sessions
The overall strategy on delivery of care is to use the Annual Conference every year to have a bolt-on training programme for doctors and nurses, and to keep a updated register of Centres with trained personel that can be contacted if major events occur. We will continue to have the Committee involved in networking with the International Radiation Preparedness community by giving lectures, attending meetings and writing papers, so as to maintain the very high level of expertise we have in the central core of the NAC. To this end having a Scientific Session at EBMT2012 to address the controversial topic of MOF post irradiation may be the template for future meetings.
Minutes London 2013
Chair: Per Ljungman
Created in 2012
The EBMT maintains a Registry of haematopoietic transplant procedures which currently contains more than 400,000 entries. The collection of data was initiated prospectively in 1975, and the Registry data is behind a large proportion of European research output, that translates into changes in clinical practice leading to improvements in patient outcome and care. The rapidly changing environment of the transplant field require a flexible, growable Registry to be able to maintain its pivotal role in supporting physicians, researchers and doctors in the clinical and business sectors with their efforts to investigate new treatments to save patient lives and improve patient care.
Advise on Registry functional development within the context of the EBMT Strategy and the Scientific evolution of the HSCT and cell therapy fields.
The Registry Committee has 2 Subcommittees:
1. Definition Subcommittee - Reach consensus on definitions or other issues being debated which affect the data stored in the EBMT Registry
2. Registry Subcommittee
1. The RC members will use their expertise to ensure that the Registry develops in line with the scientific current needs and future evolution of the HSCT and cellular therapy fields
2. The RC will advise and inform the Board regarding current and future Registry projects, including the Registry Upgrade
3. The RC will analyse functional requirements, costs-effectiveness and feasibility of Working Party or Committee requests
Donor Outcomes Committee
Chair: Joerg Halter
Created in 2012
Donor outcome is an important and integral part of allogeneic HSCT. This has now also been stated in the guiding principles on human cell, tissue and organ transplantation by the WHO. Follow up of unrelated HSC-donors as required by WMDA is already well established in individual registries. They report severe adverse reactions and severe adverse product reactions to WMDA through a SEAR/SPEAR database. However many registries do not have own electronic databases for systematic donor outcome follow up of their donors. Data from systematic follow up of related donors are still scarce due to multiple reasons. One of them is the lack of a common database which would allow entering donor data in a rational and effective way. Today we estimate from the available (not really robust) data about 1 serious adverse reaction (SAR) in 3-5000 donations and about 1 lethal event in 10-20’000 donations in related donors. These incidences might be higher than in volunteer unrelated donors but –as already mentioned- robust numbers are lacking and definition of SAR may vary between different investigators.
1. To build up a database in the EBMT registry system for donor outcome follow up for centres and interested registries
2. To provide robust data on short and long term donor safety
3. To develop recommendations for donor eligibility, donor selection and outcome follow up based on donor health characteristics
1. educational courses
2. protocol review for donor registry studies
3. strong interactions with donor committees from other member societies of WBMT
1. Creation of a donor outcome form and prepare for publication on the EBMT website
2. Writing a short manual for data managers for the donor outcome form and prepare for publication
3. Contacting centres and registries and motivate them for collaboration
Chair: John Snowden
For more information, visit the JACIE website:
Chair: Norbert Claude Gorin
Created in October 2016
In October 2016, the EBMT Board decided to create a so-called “Global Committee” to favour and welcome colleagues and teams from outside Europe to extend our common experience and skills.
Many young investigators and research fellows, in particular young Chinese colleagues, have trained in EBMT centers in France and Germany. More recently young Chinese investigators and nurses have worked at the EBMT Paris Office and produced pioneering studies comparing the results of Chinese and European new transplant technologies.
Chinese haematology has boomed in the past decade and the number of transplants done each year now reaches almost 2,000. Chinese teams have developed interesting new approaches such as haploidentical transplants following myeloablative regimen, combination of haploidentical and cord blood as sources of stem cells etc. Likewise other countries in Asia have built similar modern transplant units and create or join other scientific structures such as the Asian Pacific Blood and Marrow Transplantation group (APBMT).
In view of the growing cooperation between many Chinese and European teams, including for instance four joint French-Chinese symposia since 2012 and the next one scheduled in June 2017 in Marseille, the first action for the years 2016 and 2017 concerns Asia, in general, and China in particular.
Meanwhile the EBMT is heartily welcoming teams from other countries and specific actions will be planned in the next years for other locations.
1. Promote the EBMT mission outside Europe, starting with Asia but also other parts of the world, increase European knowledge from the experience in Asia and export to Asia the European experience
2. Increase the recruitment of EBMT teams and the numbers of transplants reported to the registry. Enlarge the data base
3. Translate in all languages (Mandarin in China as an example) the items in use in the EBMT collection and analysis software
4. Promote comparisons of transplant methodologies
5. Reactivate centre effect studies that would take benefit from the addition of new teams with different therapeutic approaches
6. Enlarge targets for educational meetings
7. Promote EBMT and all its member teams (historical and new joining members) through joint scientific meetings
8. Increase the exchanges with young investigators and PI for retrospective studies
9. Promote the exchange of nurses specialised in stem cell transplantation
10. Propose JACIE program worldwide
1. Monitoring of membership outside Europe and specifically in Asia for the year 2017
2. Ensure compatibility between registries (EBMT and national registries)
3. Further increase in the development of joint meetings regrouping European and non European teams, with a specific focus in 2017 for Asiatic teams
4. Annual report to the Board
Legal & Regulatory Affairs Committee (LRAC)
The EBMT Board agreed earlier in 2017 to establish a LRAC to guide the EBMT’s interactions with national and European regulatory authorities and other bodies.
The founding members are:
- Christian Chabannon (F)
- Jürgen Kuball (NL)
- Gerard Bos (NL)
- Mikulas Hrubisko (SK)
- Gunnar Kvalheim (NO)
- Martin Hildebrandt (D)
The LRAC is supported by Eoin McGrath, the JACIE Operations Manager.
The LRAC will build on the existing relationships and provide a ‘watchdog’ role in terms of regulations and guidelines that affect our sector. One of the first actions of the LRAC will be to contact EBMT members who are already acting in an expert capacity with the EU in order to bring their knowledge and experience into the LRAC. In addition, the LRAC will prepare the EBMT’s contribution to the EU’s evaluation of the Tissue and Cells Directives.
More information HERE
Minutes of Meetings
Meeting between the Common Representation of SoHO's associations and DG SANTE - 14 March 2017
Meeting between the EBMT and DG SANTE - 10 November 2016
Meeting between the EBMT and DG SANTE - 21 June 2016