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Activity Number: 648
Type: Topic Contributed
Date/Time: Thursday, August 4, 2016 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #320035 View Presentation
Title: Outside the Closed Door: Industry Statisticians Discuss the DMC Process
Author(s): Paul Gallo* and Walt Offen* and Markus Abt* and Gordon Sun* and Gary Aras*
Companies: Novartis and AbbVie and Roche/Genentech and BioMarin and Amgen
Keywords: DMC ; DSMB ; IDMC ; Clinical trial ; Clinical study ; Safety monitoring
Abstract:

Session Description: Data Monitoring Committees (DMCs) meet throughout a clinical study to help protect the safety of study participants, the credibility of the study and the validity of study results. Industry statisticians interact with DMCs as they are formed and perform their reviews. This panel will gain the thoughts from industry leaders on their preferred process of interactions with DMCs.

Topics may include: 1) identifying DMC members, 2) dealing with a DMC recommendation for a major change to the study, 3) implementing adaptive designs with a DMC, 4) deciding whether to program DMC reports in-house or outsource, 5) choosing an Independent Statistical Center (ISC), 6) creating standardized documents (e.g. DMC Charter) for use throughout the company, 7) utilizing a DMC for program-wide review, 8) choosing whether to provide the DMC efficacy data, 9) presenting results fully unblinded or merely A vs. B, 10) reconciling output with the ISC, 11) dealing with SDTM data for early DMC reviews, and 12) retelling particularly good and particularly unpleasant DMC experiences.


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

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