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Activity Number:
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431
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 6, 2008 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301689 |
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Title:
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Beyond Standard Reports
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Author(s):
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Vipin Arora*+
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Companies:
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Takeda Pharmaceuticals North America
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Address:
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One Deerfield Parkway, Deerfield, IL, 60015,
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Keywords:
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DMC ; Independent Statistician ; creative
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Abstract:
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Data Monitoring Committee (DMC) has responsibility to make a recommendation based on the submitted data. DMC relies heavily on the data package submitted. However, DMC is often looks beyond the submitted data package to assess alternate scenarios that may lead to a different decision/recommendation. The resources used by DMC may include Independent Statistician, Literature available on a similar class of compounds or therapies. Tools like simulation are also used to look beyond the observed data and predict the safety and efficacy of the investigative compound. Such indulgence by DMC is extremely critical and needs resources. The security walls between Independent Statistician and clinical trial team limits the data sharing and poses an operational problem. To protect the integrity of the trial, DMC needs to be creative and proactively think of using alternative resources.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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