The focus of work package 2 of the project is to create a clinical trials database so as 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, eg. national transplant societies, unrelated donor registries and the CIBMTR . To this effect we will create a clinical trials database in accordance with GCP and the EU directive; this database will be linked with the existing EBMT registry database electronically allowing exchange of data where trial confidentiality is not put at risk.
In practice this entails agreeing with the various organisations, principally the CIBMTR, on a standard data set for outcome of transplantation. This will facilitate the conduct of prospective and retrospective studies worldwide by minimising differences in data collection and database use. It will have the secondary effect of decreasing the workload for the individual transplant centre and maximising the chances of receiving high quality data promptly. The benefits of such a system cannot be underestimated in importance in the conduct of high quality data collection and analysis, and effective resource management.
Description of work
| Task 1: |
To compare data collection forms from CIBMTR, EBMT and NMDP (the latter as an example of a non-European unrelated registry) and the European unrelated donor registries. This task has been extended to working also with Eurocord on the cord blood data forms. |
| Task 2: |
To work with these organisations in deciding on the importance or otherwise of the divergent items and to reach a conclusion concerning the final core data. |
| Task 3: |
To design and implement the new collection forms. |
| Task 4: |
To create an EBMT clinical trials database. Database dictionaries will be kept as constant as possible with input from the other transplant organisations. |
| Task 5: |
Link national society and unrelated donor registries through the CLINT portal (see work package 4) and provide access rights to the EBMT registry to authorised individuals |
For a progress report on the activities and deliverables related to the data management work package visit work package 2