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Methods for strengthening the design...

Dann, Rebekkah S.

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Methods for strengthening the design and analysis of clinical trials to show non-inferiority of a new treatment to a reference treatment for a binary response variable.

Record Type:	Electronic resources : Monograph/item
Title/Author:	Methods for strengthening the design and analysis of clinical trials to show non-inferiority of a new treatment to a reference treatment for a binary response variable./
Author:	Dann, Rebekkah S.
Description:	216 p.
Notes:	Source: Dissertation Abstracts International, Volume: 67-10, Section: B, page: 5827.
Contained By:	Dissertation Abstracts International67-10B.
Subject:	Biology, Biostatistics. -
Online resource:	http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=3239285
ISBN:	9780542941450

Methods for strengthening the design and analysis of clinical trials to show non-inferiority of a new treatment to a reference treatment for a binary response variable.
Dann, Rebekkah S.

Methods for strengthening the design and analysis of clinical trials to show non-inferiority of a new treatment to a reference treatment for a binary response variable. - 216 p.

Source: Dissertation Abstracts International, Volume: 67-10, Section: B, page: 5827.

Thesis (Ph.D.)--The University of North Carolina at Chapel Hill, 2006.

Non-inferiority clinical trials are increasingly becoming more prominent in research and development of new pharamaceuticals. The objective of such trials is to show that the amount by which a new treatment is worse than an active control is below a specified amount. Methodology specifically for the design and analysis of these trials is essential for the assurance of quality trials that are statistically defensible in the scientific community as well as in a regulatory setting, where traditionally focus has been on superiority.

ISBN: 9780542941450Subjects--Topical Terms:

1018416
Biology, Biostatistics.

Methods for strengthening the design and analysis of clinical trials to show non-inferiority of a new treatment to a reference treatment for a binary response variable.
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100 1 $a Dann, Rebekkah S. $3 1921474
245 1 0 $a Methods for strengthening the design and analysis of clinical trials to show non-inferiority of a new treatment to a reference treatment for a binary response variable.
300 $a 216 p.
500 $a Source: Dissertation Abstracts International, Volume: 67-10, Section: B, page: 5827.
500 $a Adviser: Gary Koch.
502 $a Thesis (Ph.D.)--The University of North Carolina at Chapel Hill, 2006.
520 $a Non-inferiority clinical trials are increasingly becoming more prominent in research and development of new pharamaceuticals. The objective of such trials is to show that the amount by which a new treatment is worse than an active control is below a specified amount. Methodology specifically for the design and analysis of these trials is essential for the assurance of quality trials that are statistically defensible in the scientific community as well as in a regulatory setting, where traditionally focus has been on superiority.
520 $a Standard methodology must be reviewed and assessed as to its appropriateness for addressing the non-inferiority hypothesis. Categorical data analysis for a dichotomous primary endpoint may include analysis of a risk ratio or a risk difference which compares the test and active control treatments. The effect of sample size allocation and other parameters of interest on the performance of these methods will be assessed. In addition, appropriate sample size formulas will be developed and evaluated to aid in trial planning.
520 $a In some non-inferiority trials, it is possible to include a placebo arm as well as an active control arm which allows non-inferiority to be assessed relative to the percentage of the difference between the control and placebo arms that the test treatment preserves over placebo. Methodology for this assessment is also of interest along with appropriate sample size calculations. This setting also presents an area of research for discussion of the one versus two trials paradigm.
520 $a Extensions to the methodology for the risk ratio and risk difference are assessed when stratification is necessary, specifically for large subgroups such as gender. Methods for stratification are an important component, and additionally the effects of stratification in a non-inferiority setting need evaluation.
520 $a Review, development, and assessment of this methodology for categorical data as specifically focused on the non-inferiority setting is an important addition to the current statistical practice. This research is a cohesive presentation for each of the measures of interest through assessment of methodology and its relation to appropriate design components such as sample size calculation. The importance of helping statisticians understand and implement methods in these areas is of most concern.
590 $a School code: 0153.
650 4 $a Biology, Biostatistics. $3 1018416
650 4 $a Statistics. $3 517247
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710 2 0 $a The University of North Carolina at Chapel Hill. $3 1017449
773 0 $t Dissertation Abstracts International $g 67-10B.
790 1 0 $a Koch, Gary, $e advisor
790 $a 0153
791 $a Ph.D.
792 $a 2006
856 4 0 $u http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=3239285