inauguration of a Stem Cell Therapeutic Outcomes Database (SCTOD) mandated by the C. W. Bill Young Transplant Program, which was enacted in December 2005. The new law requires outcome data to be submitted on all allogeneic hematopoietic stem cell transplants where either the recipient or donor is in the United States.
The CIBMTR has been awarded the federal contract to maintain the SCTOD and has, in collaboration with the National Marrow Donor Program (NMDP), expanded its data collection forms and electronic systems to include the necessary data. The TED (Transplant Essential Data) forms have been revised in collaboration with the European Group for Blood and Marrow Transplantation. The database will be used for evaluation of the program’s operations, including federally required research such as analyses of transplant center-specific outcomes and optimal registry/cord blood bank size.
“The CIBMTR will continue to collect data for scientific research, both at the TED level and comprehensive research report forms on a subset of allogeneic and autologous transplants,” said Mary Horowitz, MD, MS, chief scientific director of the CIBMTR. “Although these activities are not part of the SCTOD, we have taken advantage of the many changes required to implement the SCTOD to make some additional changes that we think will significantly enhance our research program and assist centers who participate in that program.”
The CIBMTR and NMDP have harmonized their respective Research Report Forms into a single set of forms. The CIBMTR and NMDP also have developed an overall data management plan that includes electronic data submission of the TED forms and the harmonized research forms, a combined audit program, and combined data submission policies and procedures. Centers will no longer submit data to both the NMDP and CIBMTR. Starting in July, they submit forms to their assigned campus either in Milwaukee or Minneapolis.
Transplant centers have been informed about the upcoming changes for the SCTOD at the BMT Tandem Meetings in February in Keystone and in recent e-mail communications. This month centers will receive a packet of information providing further details about the SCTOD and how it impacts their center. Also included in the packet will be sample copies of the TED forms and the harmonized research forms.