Data Safety and Monitoring Board

The University of Arizona Cancer Center Data Safety and Monitoring Board (DSMB) has been established to ensure subject safety by coordinating, monitoring, and providing oversight for study data and subject safety for University of Arizona Cancer Center interventional clinical trials. For all investigator-initiated clinical trials without an external DSMB, the University of Arizona Cancer Center DSMB serves as the study-specific DSMB (if required, according to DSMB guidelines). The data safety and monitoring plans for trials are based on the determined risk level of the clinical trials as defined in the UACC DSMB Charter.

Members

Meetings

The DSMB meets on the fourth Thursday of each month.

DSMB meetings are scheduled monthly to ensure regular reviews of high-risk trials. However, the DSMB will review trials categorized as medium and low risk on a quarterly basis. Additional meetings may be scheduled ad hoc depending on the type, risk level, and progress of trials within their purview or to address specific issues that require immediate attention to ensure subject safety.  The DSMB is empowered to suspend subject accrual and recommend closure based on the finding of a detailed review.

For IITs on which the University of Arizona Cancer Center DSMB serves as the local study-specific DSMB, elements included in periodic review include:

• PI oversight activities of trial
• narrative description of adverse events and serious adverse events
• list of reported adverse events
• explanation of protocol-determined early stopping rules for safety and/or treatment of emergent adverse events
• status of the study in relationship to protocol-determined early stopping rules for efficacy or futility
• status of the routine monitoring duties and protocol compliance
• dose level of agent(s) involved
• list of all serious adverse events (SAEs)

The majority of trials overseen by the University of Arizona Cancer Center DSMB include interventional treatment trials including pilot, Phase I, and Phase II trials with investigational agents or new combination regimens. Pilot, Phase I, and early Phase II trials reflect the disease-focused interests of the University of Arizona Cancer Center investigators. Due to the limited size of the patient population, investigator-initiated randomized Phase III treatment trials are not generally conducted at the University of Arizona Cancer Center. If there was an investigator-initiated Phase III treatment trial, or a large randomized Phase II trial, such a study may require an independent external study-specific DSMB, which would be defined within the protocol-specific DSM plan.

When and How to Contact DSMB

Submit a protocol draft to the DSMB coordinator at UACC-DSMB@uacc.arizona.edu for assignment of a risk level and to obtain template DSM plan language consistent with assigned risk level.