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Activity Number:
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557
- Data Monitoring Committees – the Multi-Disciplinary Approach to Drug Safety Assessment
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, July 31, 2019 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #304643
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Presentation
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Title:
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A Journey Through Guidelines for DMC in Addressing Evolving Paradigm Changes – What Really Matters
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Author(s):
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Estelle Russek-Cohen*
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Companies:
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FDA CDER
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Keywords:
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safety monitoring;
FDA
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Abstract:
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Data monitoring committees have been around for several decades. At the FDA these are only mandatory when individual informed consent is not feasible (eg investigating treatments for trauma victims) and only community consent is an option. However, DMCs provide a role in enhancing trial integrity and DMCs enhance the success of many trials. In 2006 FDA issued a guidance on DMCs with recommendations. Since then there have been several changes both outside and inside of FDA. More DMCs are asked to manage multiple trials within an overall drug development trial. There has been a rise in the number of trials utilizing DMCs, a rise in the number of adaptive designs and a change in reporting of adverse events that ask sponsors to consider the potential for causality of the investigational drug. These may impact the DMC (including the DMC statistician) and its assigned tasks. FDA also recognizes that the role of the DMCs could vary depending on the depth of expertise internal to the trial sponsor. Some of these changes and how they could impact a DMC are discussed.
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Authors who are presenting talks have a * after their name.
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