Responsibilities of the DSMC
Reviews and approves the research protocol(s) and plans for data and safety monitoring. The DSMC, in collaboration with the study leadership, should establish specific guidelines for monitoring for safety. This should include a listing of events that should be reported immediately to the DSMC and the format for reporting cumulative data at intervals.
Reviews interim analyses of outcome data and cumulative toxicity data for safety and efficacy to determine whether the trial should continue as originally designed, should be changed, or should be terminated. The DSMC reviews trial performance information such as patient recruitment and retention, clinical center and resource center performance, and evaluates any additional studies proposed for their impact on the conduct and integrity of the parent project. It provides advice to the investigators and the NEI on these topics. The DSMC also recommends whether and to whom outcome results should be released prior to the reporting of study results.
Reviews and approves the primary trial manuscript(s) with regard to determining that the results are fairly presented and the conclusions appropriate.
Reviews published reports of related studies submitted by NEI, the study leadership, or DSMC members to determine whether the monitored study needs to be changed or terminated.
Reviews proposed modifications to the study prior to their implementation (e.g., increasing target sample size, dropping an arm based on other trial outcomes or toxicity results).
Following each DSMC meeting, provides the study leadership and the NEI with written recommendations related to continuing, changing, or terminating the trial. The study leadership will provide information on relevant recommendations to each clinical center director to be shared with their IRBs.