Data and Safety Monitoring Board
What is the DSMB?
Data safety and monitoring is a mandated component for oncology clinical trials associated with the UF Health Cancer Center (UFHCC). The level of data and safety monitoring activity required for a given clinical trial depends on the risk to the patients and the complexity of the trial. The UFHCC Protocol Review and Monitoring Committee (PRMC) and/or the UFHCC’s Data and Safety Monitoring Board (DSMB) are responsible for:
- Determining the appropriate level of data and safety monitoring
- Assessing risk and complexity
- Reviewing serious adverse event reports and other study results
- Reviewing data and safety monitoring reports
- Reviewing audit reports
- Recommending appropriate actions to the PRMC
- Preparing minutes of bi-annual meetings
What authority and responsibility does the DSMB have?
The DSMB is a joint multidisciplinary committee between the UF Health Cancer Center, the UF Health Cancer Center-Orlando Health (UFHCC-OH) and the UF Health Proton Therapy Institute (UFPTI). The committee’s mission is to ensure the safety of patients participating in clinical trials at the noted institutions. The three participating institutions are also committed to data accuracy and protocol compliance. Therefore, we have established a UF Health Cancer Center plan to assure data safety and monitoring for all clinical trials at our institution. This plan is designed to comply with policies and guidelines regarding data and safety monitoring from the National Institutes of Health and the National Cancer Institute.
Data and safety monitoring takes place within the established process of protocol review and monitoring by the PRMC, the Institutional Review Board (IRB) and the DSMB.
The DSMB is the primary agent for assuring data and safety monitoring. The DSMB includes co-chairpersons and faculty members from the UF Health Cancer Center, UF Health Cancer Center – Orlando Health and the UF Proton Therapy Institute and are a multidisciplinary representation from clinical researchers, also with bio statistical support.
What is taken into consideration during a risk assessment for my study?
The PRMC must approve all oncology clinical trial protocols that utilize UFHCC resources before they can be submitted to the IRB. All clinical trial protocols, excluding low-risk behavioral, nutritional, psychosocial and other non-therapeutic research protocols submitted to PRMC must include a data and safety monitoring plan and procedures for its implementation, including a system for determining and reporting Serious Adverse Events and unexpected adverse events.
“All” clinical trial protocols include national cooperative group and pharmaceutical industry trials, although, as noted above, these trials rely on the data and safety monitoring plans/procedures established by the sponsor. Protocols without such plans are returned to investigators. PRMC will not approve a clinical trial protocol that does not address data and safety monitoring.
For local investigator-initiated trials and other trials without established data safety and monitoring plans, PRMC will review the protocol and determine the appropriate level of monitoring required. Review frequency will be determined based upon the protocol’s level of risk to patients and its complexity. All studies will be monitored annually as the minimum.
Protocols will be classified into one of the following categories of risk:
- Level 0 – Nutritional, behavioral, psychosocial, and other non-therapeutic or non-intervention studies without significant health or safety risks. These studies will not require monitoring by the UFHCC DSMB as there is little risk involved in these studies. Monitoring will be primarily through the principal investigator and study coordinator. PRMC will only monitor accrual and resource utilization.
- Level 1 – NCI Cooperative Group trials. These studies will not require monitoring by the UFHCC DSMB as they are already monitored by mandated, long-standing data and safety monitoring committees at the cooperative group level. PRMC will only monitor accrual and resource utilization.
- Level 2 – Low- to moderate-risk pharmaceutical industry sponsored or principal iInvestigator initiated therapeutic intervention (such as drug, biologic or device) trials. These studies will require annual monitoring by the UFHCC DSMB.
- Level 3 – High-risk pharmaceutical industry sponsored or principal investigator initiated therapeutic intervention trials (such as investigator-sponsored INDs, Phase I trials or gene therapy or other areas that may be designated by NIH as high risk). These studies will require semi-annual monitoring by the UFHCC DSMB.
- Level 4 – Complex trials involving major risk to subjects and a high level of complexity. Intense monitoring is required for these studies, with a study specific, independent DSMB responsible for the monitoring. The data and safety monitoring plan must be defined in the protocol.
Requirements for periodic data and safety monitoring are commensurate to the clinical trial’s risk and complexity. The requirements outlined above represent the minimum. The IRB, PRMC and/or DSMB may require more frequent and/or additional monitoring to assure patient safety and trial integrity. Data safety and monitoring activities continues until all patients have completed their treatment and until all patients have been followed beyond the time point at which study-related adverse events would likely be encountered.
Can the DSMB close my study?
The DSMB cannot close the study, but it can make recommendations to the PRMC and the IRB regarding the suspension or termination of a clinical trial protocol. Notice of early closure or suspension can be recommended to PRMC by the DSMB. PRMC can execute the DSMB’s recommendation. If the trial is an NCI-funded clinical trial, the principal investigator is responsible for reporting closure/suspension to the NCI and IRB. The DSMB chairperson should confirm that the principal investigator has notified the NCI. PRMC and the IRB are responsible for seeing that these trials are closed to accrual.
What are common reasons the DSMB will recommend that my study be closed?
First and foremost, the committee’s mission is to ensure the safety of patients participating in clinical trials at its institutions. For that reason, the DSMB may decide to close a study where study related drug toxicities exceed the proposed benefit of that investigational treatment. Additionally, if the efficacy of an intervention is determined to be futile, an amendment to the study or a notice for study closure can be recommended by the DSMB.
Who can I speak to regarding the DSMB or for more information?
For information related to the DSMB, please contact Brian Sevier, associate director at firstname.lastname@example.org or 352.273.8280; or David Ortiz, PRMC and DSMB coordinator at email@example.com or 321.841.7031
This core is available to individuals who are Cancer Center members. In order to become a member of the UF Health Cancer Center, please visit the membership policy and application site. For further questions about membership with the UFHCC, please contact Wendy Malorzo or call 352.273.8294.