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Activity Number:
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481
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Type:
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Roundtables
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Date/Time:
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Wednesday, August 5, 2009 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304462 |
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Title:
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The Role of the Unblinded Statistician and Their Relationship with the DSMB
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Author(s):
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Valerie Durkalski*+
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Companies:
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Medical University of South Carolina
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Address:
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135 Cannon St, Ste 303, Charleston, SC, 29425,
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Keywords:
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DSMB ; clinical trial ; interim analysis ; safety reporting
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Abstract:
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The NIH requires that every Phase III clinical trial have an external data and safety monitoring board (DSMB). For each DSMB there should be an appointed statistician, usually a study team member, responsible for creating interim reports and presenting this information to the DSMB on a study specific reporting timeline. This often is an isolated role since this person has access to safety/efficacy data in a partial or complete unblinded format. Several complicated issues can arise during a study such as presentation of unplanned efficacy analyses and/or unexpected safety issues. The complexities of these situations often require consultation but who the unblinded statistician should consult with is a big question. We will share specific scenarios that the discussion leader and roundtable participants have experienced and discuss the approach taken to address each scenario.
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