The role of data and safety monitoring in acute trauma resuscitation research

BACKGROUND: The role of data and safety monitoring boards (DSMBs) in clinical research in acute trauma resuscitation is not well documented. Many of the difficulties conducting acute resuscitation research are exacerbated because multlinstitutional studies are needed to adequately power such research. STUDY DESIGN: The purpose of the study was to demonstrate how a well-organized DSMB, explicitly required for these types of clinical trials by many funding agencies, can be a valuable resource in their safe and successful conduct by maximizing data integrity and striving to standardize care by monitoring the consistent and accurate collection of data and adherence to protocol. As an example, the work of an external DSMB in an international multicenter trial of recombinant activated coagulation factor VIIa (rFVIIa) in blunt and penetrating trauma patients is presented. The DSMB in this study was responsible for reviewing all serious adverse event (SAE) data, performing an extended review of SAEs, and reviewing results of analyses of 48-hour and 30-day mortality according to prespecified study stopping rules. RESULTS: Application by the DSMB of uniform definitions of SAEs substantially improved the integrity of the study data and facilitated analysis of events, such as disseminated coagulopathy, pulmonary complications, and multiple organ failure. As a result of the DSMB's efforts, important insights were gained to guide site selection and conduct of future trials of rFVIIa in trauma-induced hemorrhage. CONCLUSIONS: Based on our experience as members of the study DSMB and on a review of the literature, we recommend a strong role for DSMBs in multicenter trials in acute resuscitative care.