Standardisation of essential data collection and the development of a clinical trials database in accordance with GCP and the EU Clinical Trials Directive
The key objectives of this work package are to:
- agree and implement a standard data set for outcome of transplantation with other organisations active in field
- create a clinical trials database to facilitate the conduct of academically led prospective clinical trials across national boundaries and to augment sharing of trial data for meta-analysis with other national and international transplant organisations e.g. national transplant societies, unrelated donor registries and the CIBMTR
Carmen Ruiz (Head of the EBMT Registry) and Mary Horowitz (Director of CIBMTR) are acting as joint work package leaders in delivering this aspect of the project.
Standardisation of data collection is an ongoing and long-term project of the EBMT and CIBMTR. Standardisation is essential for reducing the data reporting budget burden placed on transplant centres and this is a key objective of both organisations. The initial focus of this work has been on reviewing the Minimum Essential Data (MEDA/TED) and reaching agreement on a core data set. This was accomplished by June 2007 and the new MED A form was implemented in the EBMT database in January 2008. A number of additional items required by CIBMTR have been included in an appendix to the MED A in order to facilitate reporting by centres who wish to submit data to both EBMT and CIBMTR. The appendix has been implemented in the EBMT database to facilitate the transfer of this data to CIBMTR. The MEDA / TED forms are available on the EBMT and CIBMTR websites respectively:
Overview of data collection forms:
The Definitions Committee continues to work on refining the core data set by examining disease dependent items to ensure that common terminology is in usage.
Given the successful progress in this area of the project, it has been decided by the CLINT Steering Committee to extend the project deliverables to include comparison and agreement of a core data set for cord blood transplantation. Vanderson Rocha (Chair of the EBMT Acute Leukaemia WP and Clinical Coordinator of the Eurocord registry) has been seconded to CIBMTR to begin a project to harmonise the reporting elements and data flow and it is an objective of the project to finalise the data set and produce a form by month 24 (March 2009).
It is also intended to improve data sharing at a broader level by providing a link from AGNIS (‘A Growable Network Information Systems’) to the EBMT database and CLINT portal. AGNIS is a system for data exchange, which is currently being developed by CIBMTR and NMDP under an NIH contract. It is anticipated the system will be partially operational in the next few months.
In March 2007 on the initiative of the EBMT, CIBMTR and the Asia Pacific Blood and Marrow Transplant Registry (APBMT), in collaboration with World Marrow Donor Association (WMDA), a meeting was organised in Lyon with representatives of other continents and countries to discuss the establishment of a global network of outcome registries called the Worldwide Network for Blood and Marrow Transplantation (WBMT). Part of the remit of the WBMT is to seek the maintenance of consensus on a common data set for donors and recipients at the global level. At the 3rd WBMT meeting, held in Florence on 2 April 2008, CIBMTR gave an update on the development of AGNIS and plans for implementing a data pipeline for the sharing of cord blood data between EBMT, CIBMTR and Eurocord.
In relation to the creation of a clinical trials database, the EBMT’s ProMISe system has been used to create a clinical trials database system, which is being used to implement the Myfortic trial. The system has been tested and further developed and a second trial, MMVAR, is currently being implemented. At the same time the EBMT has been evaluating other IT software available on the market to support registration level studies for the future and following a Board decision in March will proceed to implement a new software package supplied by Velos.
Deliverables: April 2007 – September 2009
Comparison of current core data sets:
- Core data set delivered at M3 and
- Core data set implemented in M9
| Month 12
MED A form
Decision regarding final desired data sets
New common cord blood data set
Cord blood data form
|| Clinical trials database
||Month 12, month 30
Clinical trials database created using ProMISe software by month 12 (demonstration)
New database with state of the art software delivered by month 30 (Demonstration)