This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
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Activity Number:
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469
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Type:
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Contributed
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Date/Time:
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Wednesday, August 4, 2010 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #307451 |
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Title:
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The Case for Embedding a Detailed Statistical Analysis Plan in Clinical Trial Protocols
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Author(s):
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Keaven M. Anderson*+ and Chris Assaid+
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Companies:
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Merck Research Laboratories
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Address:
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351 N Sumneytown Pike, North Wales, PA, 19454, UG 1C-46 POB 1000, North Wales, PA, 19454-0001,
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Keywords:
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Statistical Analysis Plan ;
Clinical Trial Protocols
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Abstract:
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The question regarding the level of detail related to the Statistical Analysis Plan (SAP) in clinical trial protocols is an age-old one, with opinions covering the extremes. Regulatory authorities have their own concerns, which may or may not be aligned with those of sponsor biostatisticians. Many factors influence this decision, from resources to protocol length to strategic philosophies. We outline the rationale for including a detailed SAP in late-stage protocols, which includes a description of a high level discussion with regulatory statisticians, as well as practical considerations/experiences from trial sponsors. We also describe implementation via a user-friendly template that includes standardized structure and textual descriptions of preferred analytical methods; examples of the successful use of this approach across multiple therapeutic areas at Merck will be provided.
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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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