Data Monitoring Committees (DMCs) are groups of independent experts who periodically receive (by-arm) reports created by an independent Statistical Data Analysis Center (SDAC) using interim data from ongoing studies. The role of the DMC is to make recommendations about the continuation of the studies based on their best judgment and sometimes specified guidelines.
The DMC typically includes at least one statistician who votes on the decision to recommend stopping, modifying, or continuing a study. The SDAC typically is represented by at least one independent statistician and these statisticians are intermediaries between the sponsor and the DMC. The SDAC independent statisticians facilitate the efforts of the DMC by preparing and presenting summary data, taking care of meeting logistics, etc. These SDAC statisticians need ‘hard skills’ such as expertise in biostatistics, experience with clinical trial data, and knowledge of the study protocol. But it is essential that these SDAC statisticians also have the ‘soft skills’ for this role. In this blog, we highlight 10 key qualifications for these SDAC independent statisticians that are less technical, but no less essential.
1. Deferential – The 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 the SDAC statisticians be assertive to get the discussion back on track when necessary.
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 report discussion, 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 other similar circumstances.
4. Poker-faced – When discussing DMC activities with study team, the SDAC statisticians need to maintain a neutral stance on the outside and not give away their inclinations by way of their body language or how questions are asked or answered. An SDAC statistician works with unblinded data and thus, along with the DMC, is the only person who truly knows the status of the study in terms of success or failure. To preserve the trial integrity, it is critical that the SDAC statistician does not betray this status in any way.
5. Tech savvy – In today’s tech age, especially with the virtual meetings in the times of the current pandemic, it is essential for SDAC statisticians to understand the ‘shared screen’ and teleconference services to manage the meetings smoothly and give tech support to struggling attendees.
6. Quick thinker – If asked a question, the SDAC statisticians should be able to decide whether they can answer immediately or need to defer on answering (For example: Answer immediately if 100% sure, or if needed instead say “Great question. I don’t immediately have the answer. Can I follow-up and get back to you after the meeting?”)
7. Diplomatic –With experience, SDAC statisticians are expected to learn to 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 DMC –In their proceedings with DMCs, SDAC statisticians may repeat or rephrase their question back to the DMC to make sure it is really understood, and perhaps suggest a counter-proposal that addresses the concern and is probably more practical to implement. The SDAC statisticians should strive to provide the DMC with what they need to make an appropriate recommendation.
9. Understands the pain points – A key quality in SDAC statisticians that can be very helpful is the ability to read body language at in-person meetings, and more importantly, read emotions over the phone which can be challenging. 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 Communicator – The SDAC statisticians should be able to record and disseminate precise minutes and draft appropriate professional email content. Good English speaking and listening skills (understanding global accents) can go a long way in successful collaborations world over.
Cytel Axio has supported clients in the planning and management of more than 600 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. Click the button to learn more.