Get to Know the SDAC
Review the Documents
Hammer Out the Charter
- The DMC’s charge and responsibilities
- Responsibilities of other study players
- The communications process, including steps to ensure confidentiality
- Disclosure of potential conflicts of interest
- Decision guidelines and statistical boundaries
- Data flow and content of the report
- Meeting logistics (governance, frequency of meeting, logistics of report distribution, etc.)
Address Tough Questions Early
- Will the DMC have access to efficacy data? This is one of the stickiest issues that comes up. It’s best to address it at the organizational meeting. The DMC members must have the ability to access efficacy data, even when reviewing only safety, because they need the ability to assess risk vs. potential benefit.
- How current will the data be? Too often, this topic gets overlooked, but DMCs need to know–if for no other reason, to control expectations.
- What’s the level of masking? Determine the level of masking the DMC expects in its closed reports. Interim DMC reports often semi-mask the treatment groups with labels such as ‘Group A’ and ‘Group B’. Sometimes, committee members will feel that the DMC should only know the true identity of the treatment upon request if needed given the emerging data. However, we generally recommend that DMC members should be aware of the treatment group identities corresponding to the semi-masked labels at the DMC’s very first report.
- How will the DMC handle futility/overwhelming efficacy? State in the charter whether one of the DMC’s charges is to consider a recommendation for trial termination due to futility or overwhelming efficacy. If this isn’t part of the DMC’s charge, the sponsor should explain why during this first meeting.
- Can the DMC hold unscheduled meetings? The charter should give the DMC the authority to conduct unscheduled meetings without notifying the sponsor. For instance, if the DMC sees a potential emerging safety signal, it may choose to meet sooner than the next planned meeting.
Clarify Communications and Confidentiality
More to Know
About the Author
Matt Downs is a Statistical Scientist at WCG Statistics Collaborative and has worked at WCG Statistics Collaborative for over 25 years. Mr. Downs has served as the Independent Reporting Statistician for over 100 industry-sponsored Data Monitoring Committees. His work with industry sponsors has ranged from preparation of DMC charters and interim analysis plans to managing the statistical programming and interim report writing. In addition to reporting to DMCs, he has also served on industry- and government-sponsored committees as the voting DMC statistician.
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