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Abstract:
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FDA's Guidance on DMCs suggests an external or "independent" statistician report unblinded data. Communication between the sponsor, DMC, and reporting statistician can take many forms, some more "independent" than others. In many cases, trials require neither a sophisticated DMC nor an experienced reporting group and the simplest models suffice. Sometimes, however, something happens that requires agility and insight from the reporting statistician, and careful reasoning from the DMC - unanticipated serious adverse events, related data from external trials, or subgroup effects. Drawing from our experience reporting to DMCs for pharmaceutical and biotech sponsors, we will discuss our philosophy of independence, which requires aggressive curiosity and thoughtful reporting from the external statistician, open exchange of information from the sponsor, and measured judgment from the DMC.
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