Do clinical trial participants have better outcomes than comparable patients who are not treated on a trial? A study by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) examined that question by analyzing outcomes of a large-scale, randomized study comparing peripheral blood with bone marrow transplantation from unrelated donors. In this case, the answer is that trial and non-trial participants had comparable HCT outcomes. Researchers compared characteristics and outcomes of 494 participants enrolling in BMT CTN trial 0201 and 1,384 likely eligible non-trial patients treated at the same centers during the same time period and received similar treatment. Outcomes data from CIBMTR (Center for International Blood and Marrow Transplant Research) showed that overall survival, transplantation-related mortality, and incidences of acute or chronic GVHD were comparable between the two groups, although relapse was higher in nonparticipants (HR: 1.22; 95% CI: 1.02 to 1.46; p=0.028) .
Comparable Survival in Clinical Trial Participants vs. Nonparticipants