A Data Safety Monitoring Committee (DSMC) monitors all phase III, randomized phase II, and advanced imaging studies of the ECOG-ACRIN Cancer Research Group. The DSMC is responsible for monitoring the progress, safety, conduct, and interim results of the monitored studies.
The DSMC is organized into two standing subcommittees: one subcommittee focuses on therapeutic studies and the other on primary imaging/diagnostic studies. The two subcommittees meet separately at least twice each year. A majority of the members are from outside ECOG-ACRIN, and include a cancer survivor and an outside statistician. The remaining members are physicians and statisticians with expertise in conducting cancer clinical trials.
Prior to each meeting, the DSMC subcommittee members receive reports on all studies for which they are responsible. The reports include the study progress and safety reports made available to the ECOG-ACRIN membership and additional confidential information, which may include additional analyses of adverse event data and information related to outcome data.
Listed below are the policies of the DSMC.
|Scientific Planning and Review|
|Biostatistics and Data Management|
|Active Clinical Trials|