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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.
At the 2019 Challenges in Rare Diseases Clinical Trials Symposium and East training, Cytel partnered with Alexion to bring together expertise from academia and industry. David Kerr, Director of DMC Services at AXIO, was among the notable speakers and his talk “Data Monitoring Committees – Behind Closed Doors” covered general considerations and options that the DMC has when reviewing the data presentations during their closed sessions. He presented four specific case studies that highlighted the data provided to the DMC from meeting to meeting and discussed how the DMC arrived at their recommendations for each meeting. We had the opportunity to sit down with David and speak about Data Monitoring Committees, understand their proceedings and talk about his presentation at the symposium.