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Activity Number:
542 - Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee)
Type: Roundtables
Date/Time: Wednesday, August 1, 2018 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract #328894
Title: Confessions of an Independent DMC Statistician
Author(s): Brian Cohen*
Companies: ACI Clinical
Keywords: Data Monitoring Committee; DMC; Dirty data; interim analysis; futility analysis

In pharmaceutical clinical trials, emphasis is given to the safety of the patients and the ethical reasons for continuing with the study. One of the tools for evaluating safety of such trials in the implementation of a Data Monitoring Committee (DMC), comprised of independent medical and statistical experts. To help DMCs, often an unblinded independent statistician is entrusted to analyze, present and facilitate the data review during the 'closed' DMC meetings. The roles of this reporting DMC statistician is quite different than that of a project statistician. This round table will be presented by a 20 plus year experienced statistician who has played both these roles. Differences such as breadth of medical knowledge, need to work with dirty data, importance of interim analyses, comparing importance in summarizing safety data and efficacy data, and timelines in producing reports will be discussed. Differences in personality characteristics and statistical skills needed for each role will be explored. The round table will allow statisticians who are not privy to closed session DMC meetings to ask a DMC statistician what goes on 'behind closed doors'.

Authors who are presenting talks have a * after their name.

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