The EBMT was established in 1974 with the express purpose of collecting data on all haemopoietic stem cell transplants performed by member centres, in order to analyse outcome and identify factors that would improve the overall survival of all patients. Over the intervening years the EBMT has achieved its original objectives and has evolved into an organisation responsible not only for data collection, analysis and reporting, but also with direct involvement in determining transplant policy in Europe. The EBMT works to the highest scientific standards, promoting all activity aimed at improving stem cell transplantation (SCT) and cellular therapy: basic and clinical research, education, standardisation, quality control and management, and accreditation. For over 30 years, the EBMT has been a leader in the collection and analysis of patient transplant data in Europe, as well as an initiator of pioneering prospective studies that use new ideas and techniques within the field of autologous and allogeneic haematopoietic stem cell transplantation (HSCT).
The EBMT represents 530 member centres reporting data on >27,000 transplants per annum. The central database, or ‘megafile’ contains demographic, disease specific, transplant specific and outcome data on >297,000 patients and their donors. Many European countries now require their transplant units to report to either the EBMT directly or via a national transplant society. Data are collected in a number of ways, including paper forms, but increasingly centres are switching to an online internet based reporting system, ProMISe. In keeping with a philosophy that promoted trans-national access from the start, data management offices are distributed throughout Europe, utilising both central and local resources. Offices exist in Barcelona, Leiden, London and Paris with senior biostatistical support in London; Paris and Leiden. The major annual meeting, occurring in March each year, attracts over 4000 physicians, scientists, nurses and data managers involved in the field of SCT. Additional educational meetings and workshops take place throughout the year. The EBMT handbook on stem cell transplant, intended as a ‘bedside’ reference guide, is now in its fifth edition.
The members of the society are mostly transplant units, which nominate physicians, scientists, nurses and data managers as their representatives. Transplant centres are invited to participate within disease, technology or complication based Working Parties. These Working Parties are the ‘nerve centre’ of the organisation, in that their members propose, design, analyse and report research studies pertinent to their own interests. Working Parties are supported by data management and statistical help. Any EBMT member can propose a study, even if they are not active Working party members. They are then encouraged to route their idea through the Working party system to avail themselves of the support infrastructure.
The Chairs of the Working Parties are democratically elected by EBMT member centres and serve on the Board of the EBMT together with the President, President-Elect, Secretary and Treasurer. The strategic functions of the Board are supported by the Executive Officer and associated staff members. The names of all member institutions, team representatives, Working party members, Board members and EBMT personnel are freely available on the EBMT website.
Data arriving from the centres are quality controlled to ensure accuracy and completeness. The EBMT has an impressive track record of retrospective studies in all aspects of stem cell transplantation. The critical mass of data contained in the Registry has enabled the group to perform retrospective trials in the areas of prognostic factors, trends in treatment, experimental procedures, etc. These studies have informed clinical practice over the years, improving patient outcomes, and reducing morbidity. Since its origin the EBMT have been responsible for >650 peer reviewed publications furthering the field.
EBMT looking ahead: the creation of a Clinical Trials Department
In the era of evidence-based medicine, it is ever more important that clinical practice evolves based on the results of prospective clinical trials performed in the academic setting. Many unanswered questions in transplantation are best served by prospective studies. However, the conduct of such trials has become far more complex with the introduction of the EU Clinical Trials Directive (2001/20/EC), which highlighted the necessity of creating appropriate infrastructure for the performance of prospective trials.
In 2004 the EBMT established a Prospective Clinical Trials Committee (PCTC) to address the challenges presented by the requirement for academic studies to be performed in accordance with Good Clinical Practice. The Committee’s remit is to foster the development of clinical trials infrastructure to meet the standards now imposed not only on the Pharmaceutical Industry but more particularly on academic groups The EBMT over the years has succeeded in establishing good relationships with colleagues from the pharmaceutical and biotechnology industries and has started to act as the Sponsor for studies with substantial financial support from the industry. This has highlighted the lack of resources to design and conduct academically initiated trials.
Recognising that the conduct of academic trans-European studies in such a specialised field will require a change in the current infrastructure, the CLINT project was submitted with the aim of seeking support to build the EBMT’s infrastructure and capacity for conducting trials in the field of SCT. In 2006 a Director of Clinical Trials Operations was appointed to oversee and develop the EBMT’s clinical trials activities run by the EBMT Clinical Trials Department through its London and Leiden offices.