The CIBMTR is a research programme formed in July 2004 through an affiliation of the International Bone Marrow Transplant Registry (IBMTR) of the Medical College of Wisconsin (MCW) and the research arm of the National Marrow Donor Program (NMDP). Both the IBMTR and NMDP have broad expertise in the field of SCT, including observational research and clinical trials. The IBMTR is a voluntary organization of > 400 transplant centers in 47 countries that have collaborated to share patient data and conduct scientific studies since 1972.
The IBMTR has a strong record of clinical research and development of statistical methodology relevant to this field. It also has an extensive database of related and unrelated donor transplantation outcomes, including >65% of the transplants performed in North and South America as well as a large number from Europe, Australia, Africa and Asia. The NMDP was established in 1987 to provide unrelated donors for patients in need of HCT and also to conduct research to improve the outcome of such transplants. The NMDP Network includes 156 transplant centers, 84 donor centers, 103 collection centers, 84 apheresis centers and 15 cord blood banks. Its database includes almost all unrelated donor transplants in the U.S. with stored donor-recipient biologic samples for a large subset of these transplants.
The IBMTR and NMDP, together with the EMMES Corporation, also function as the coordinating center for the U.S. prospective clinical trials group focusing on HCT, the Blood and Marrow Transplant Clinical Trials Network (CTN). The CTN now has 8 large multicentre trials initiated in the last three years, enrolling more than 500 patients and accruing thousands of biologic samples. In addition to facilitating data exchange the CIBMTR has additional major resources of value to European investigators. For instance, there is a large and powerful biostatistical infrastructure whose interaction with biostatisticians in Europe can only bring added value. One of the goals is to develop consensus on “best practice” for statistical design of observational research and prospective clinical trials in HCT, likely to be generalize able to other related fields. The CIBMTR and the European RIs have a wealth of experience in designing such studies that could be shared to allow:
- Education of clinical researchers and statisticians internationally
- Investigators designing to have access to statistical designs proven to be successful in prior studies
- Methodological research to improve analytic approaches to these problems
Secondly, the NMDP has demographic and tissue typing data on more than one million US citizens. As we become more sophisticated in our tissue typing techniques and able to identify increasing numbers of genetic differences between individuals, there is a danger that, in theory, we will become increasingly unlikely to find an identical match for any single patient. Some of these genetic differences may be completely unimportant in the outcome of transplant and paradoxically some of the differences may actually be beneficial. It is therefore necessary to be able to identify these ‘permissable’ or ‘desirable’ mismatches and this can only be done using very large cohorts of patients.