SampleSizeConsideration

: Public Class

Created:	9/3/2008 12:15:42 PM
Modified:	5/29/2013 4:25:59 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{7CA22211-50CD-4b3f-9F08-95BCFBCD7B22}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View SA: Statistical Analysis

DEFINITION: Information needed for computing the sample size, including any detail not provided in the study protocol. EXAMPLE(S): "Approximately 100 patients will be randomized to each of the 3 treatment groups. Previous experience with the oral formulation of xanomeline suggests that this sample size has 90% power to detect a 3.0 mean treatment difference in ADAS-Cog (p#lt;.05, two-sided), based on a standard deviation of 6.5. Furthermore, this sample size has 80% power to detect a 0.36 mean treatment difference in CIBIC+ (p#lt;.05, two-sided), based on a standard deviation of 0.9." OTHER NAME(S): NOTE(S): InterventionalStudyProtocolVersion.interventionGroupQuantity, Arm.targetAccrualNumberRange, and StudyProtocolVersion.targetAccrualNumberRange are all related to parts of the SampleSizeConsideration that are not yet fully modeled here.

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Attribute

Public ED
text

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:Statistics v1.0=SampleSizeConsideration.text

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A textual or media-based representation of the sample size consideration, including #lt;br /#gt;#lt;/p#gt;#lt;p#gt;details needed to replicate sample size calculations.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;"Approximately 100 patients will be randomized to each of the 3 treatment groups. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;Previous experience with the oral formulation of xanomeline suggests that this #lt;br /#gt;#lt;/p#gt;#lt;p#gt;sample size has 90% power to detect a 3.0 mean treatment difference in ADAS-Cog #lt;br /#gt;#lt;/p#gt;#lt;p#gt;(p#lt;.05, two-sided), based on a standard deviation of 6.5. Furthermore, this sample #lt;br /#gt;#lt;/p#gt;#lt;p#gt;size has 80% power to detect a 0.36 mean treatment difference in CIBIC+ (p#lt;.05, #lt;br /#gt;#lt;/p#gt;#lt;p#gt;two-sided), based on a standard deviation of 0.9."#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Details included could be: difference to be detected, variability, assumptions.#lt;br /#gt;#lt;/p#gt;

Element	Source Role	Target Role
StatisticalAnalysisPlanVersion Class	Name: includedSampleSizeConsideration	Name: includingStatisticalAnalysisPlanVersion
Details: DESCRIPTION:<br /></p><p>Each SampleSizeConsideration always is included in one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might include one or more SampleSizeConsideration.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Identifies the considerations that inform the calculation of the sample size for a given version of a statistical analysis plan.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>

Tag	Value
Map:Statistics v1.0	SampleSizeConsideration
Details:

Object	Type	Connection	Direction	Notes
StatisticalAnalysisPlanVersion	Class	Weak	To	DESCRIPTION: Each SampleSizeConsideration always is included in one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might include one or more SampleSizeConsideration. DEFINITION: Identifies the considerations that inform the calculation of the sample size for a given version of a statistical analysis plan. EXAMPLE(S): OTHER NAME(S): NOTE(S):