We previously discussed who participates on a Data Monitoring Committee (DMC), which is an independent group of experts who make recommendations based on reports received on interim study data. The DMC typically includes at least two clinicians and one statistician who contribute to the decision to recommend stopping, modifying, or continuing the study.  

The Statistical Data Analysis Center (SDAC), which creates the by-arm reports reviewed by the DMC, is typically represented by at least one independent statistician and this SDAC statistician is an intermediary between the sponsor and the DMC.  

Here, we discuss the critical role of the independent SDAC statistician and the essential qualifications needed to successfully fulfil this purpose. 

Independent SDAC statisticians: An intermediary between the sponsor and the DMC

This SDAC statistician is not a voting member of the DMC, but nonetheless plays a key role in the success of the DMC. The SDAC statistician facilitates the efforts of the DMC by preparing and presenting summary data, taking care of meeting logistics, and so on.  

SDAC statisticians need “hard skills” such as expertise in biostatistics, experience with clinical trial data, DMC experience (including handling and interpreting possibly immature data that is not fully cleaned), and knowledge of the study protocol. But it is essential that they also have the right “soft skills” for this role.  

Next, we highlight 10 key qualifications — less technical, but no less essential — for SDAC independent statisticians. 

Ten key qualifications for independent SDAC statisticians

1. Deferential

SDAC statisticians are expected to be respectful during the proceedings within a DMC meeting; they are not voting members and should not editorialize regarding the data or try to sway the DMC. They should be mindful of the process and maintain due decorum.

2. Assertive

Data Monitoring Committees are very sincere and serious about their role in clinical trials. However, there can be digressions during a discussion. It is expected that SDAC statisticians be assertive to get the discussion back on track when necessary, so that the DMC is able to make a recommendation.

3. Confident

The SDAC statisticians need to be confident in their conduct or at least have the appearance of confidence during the proceedings. They should clearly lead the DMC through the agenda topics and the discussion of the DMC report and clearly explain the data and the expectations of everyone involved. If the DMC is struggling with the DMC process or how to form an appropriate recommendation when faced with a tricky situation, the SDAC statistician can suggest what has been done by other DMCs in similar circumstances.

4. Discrete

When discussing DMC activities with the study team, the SDAC statistician needs to maintain a neutral stance. Communication style or content should not be suggestive of privileged DMC information or unblinded study status. This risk can be mitigated by planning as much as possible in advance — for example, asking key questions prior to unblinding (especially formal interim analyses) to ensure the SDAC statistician doesn’t have questions after unblinding that appear to be providing too much information to the study team.

5. Tech savvy

In today’s tech age, it is essential for SDAC statisticians to understand how to effectively manage virtual meetings and give tech support to struggling attendees, many times while multi-tasking.

6. Quick-thinking

If asked a question, SDAC statisticians must determine if they can answer immediately or need to defer on answering. (Answer immediately if 100% sure. If uncertain, propose a time when the information can be provided.) SDAC statisticians must take care to ensure that their responses are not informative to the sponsor.

7. Diplomatic

SDAC statisticians must be diplomatic in their approach, especially for the study team and DMC interactions. There can be differences in approaches between the sponsor and the DMC, and the SDAC statisticians are expected to serve both groups (while foremost protecting the patients and the study integrity).

8. Collaborative with the DMC

In their proceedings with DMCs, SDAC statisticians may repeat or rephrase a DMC request to confirm it is really understood. They may suggest options that address the request and are practical to implement. SDAC statisticians should strive to provide the DMC with what is needed to make an appropriate recommendation including potentially offering alternative solutions that achieve the same goal, while minimizing strains on resourcing from both the SDAC and study team.

9. Understand the pain points

SDAC statisticians need the ability to read body language at in-person meetings and, more challenging, read emotions over the phone. It is essential to detect and comprehend DMC members’ frustration and pain points to adjust the flow of the meeting or other activities appropriately.

10. Good communication skills

The SDAC statistician should be able to record and disseminate precise minutes and draft appropriate professional emails. SDAC statisticians are expected to work and communicate as part of a cross-functional team from the SDAC to support DMCs. Excellent English speaking and listening skills (understanding global accents) can go a long way in successful collaborations the world over. 

Axio, a Cytel Company, has supported clients in the planning and management of more than 1,000 Data Monitoring Committees in all major therapeutic areas — making us one of the foremost companies in this field. Our staff members are highly trained to serve as independent statisticians for DMCs, and we apply this expertise and deep DMC experience to provide turnkey solutions for monitoring patient safety and ensuring trial integrity. 

Interested in learning more? Watch our recent webinar “Effective DMCs for Oncology Studies”: 

Share Via