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Two-stage winner designs for non-inferiority trials with two to three experimental treatments and an active control

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TitleInfo
Title
Two-stage winner designs for non-inferiority trials with two to three experimental treatments and an active control
Name (type = personal)
NamePart (type = family)
Wang
NamePart (type = given)
Pin-wen
NamePart (type = date)
1976-
DisplayForm
Pin-wen Wang
Role
RoleTerm (authority = RULIB)
author
Name (type = personal)
NamePart (type = family)
Lu
NamePart (type = given)
Shou-En
DisplayForm
Shou-En Lu
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
chair
Name (type = personal)
NamePart (type = family)
LIN
NamePart (type = given)
YONG
DisplayForm
YONG LIN
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
co-chair
Name (type = personal)
NamePart (type = family)
Shih
NamePart (type = given)
Weichung Joe
DisplayForm
Weichung Joe Shih
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
internal member
Name (type = personal)
NamePart (type = family)
Lan
NamePart (type = given)
Gordon K.K.
DisplayForm
Gordon K.K. Lan
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
outside member
Name (type = corporate)
NamePart
Rutgers University
Role
RoleTerm (authority = RULIB)
degree grantor
Name (type = corporate)
NamePart
Graduate School - New Brunswick
Role
RoleTerm (authority = RULIB)
school
TypeOfResource
Text
Genre (authority = marcgt)
theses
OriginInfo
DateCreated (qualifier = exact)
2013
DateOther (qualifier = exact); (type = degree)
2013-05
Place
PlaceTerm (type = code)
xx
Language
LanguageTerm (authority = ISO639-2b); (type = code)
eng
Abstract (type = abstract)
In drug development, two-stage winner design can be cost-effective when the best treatment is to be determined from multiple experimental treatments. In this design, an interim analysis is devised to select the best treatment to avoid high cost, long-term trial conduction, and exposure to ineffective treatments. When an existing effective treatment is available, but new experimental treatments have advantages such as less cost, easier delivery, less invasive and fewer side effects, etc., including placebo in the trial may be considered unethical. It is desirable to conduct a non-inferiority trial that directly compares new treatments with the existing treatment (active control), and show that the new treatments are not less effective than the active control by a certain amount (so called non-inferiority margin). In this dissertation, we extended the framework of the two-stage winner design of Shun et al. (2008) to conduct non-inferiority tests. Specifically, we considered designs of trials with two or three experimental treatments and an active control. Our methods include superiority hypotheses as a special case, but the hypothesis setting is more general than that studied by Shun et al.. We studied the distribution of test statistics, cut-off values, sample size and power calculations using exact distribution of the test statistics as well as using normal approximations. Theoretical justifications and extensive numerical assessments were conducted to calculate the design parameters and evaluate the performance of our methods.
Subject (authority = RUETD)
Topic
Public Health
RelatedItem (type = host)
TitleInfo
Title
Rutgers University Electronic Theses and Dissertations
Identifier (type = RULIB)
ETD
Identifier
ETD_4559
PhysicalDescription
Form (authority = gmd)
electronic resource
InternetMediaType
application/pdf
InternetMediaType
text/xml
Extent
xviii, 179 p. : ill.
Note (type = degree)
Ph.D.
Note (type = bibliography)
Includes bibliographical references
Note (type = vita)
Includes vita
Note (type = statement of responsibility)
by Pin-wen Wang
Subject (authority = ETD-LCSH)
Topic
Drug development
Subject (authority = ETD-LCSH)
Topic
Drugs--Testing
Subject (authority = ETD-LCSH)
Topic
Drug delivery systems
Identifier (type = hdl)
http://hdl.rutgers.edu/1782.1/rucore10001600001.ETD.000068996
RelatedItem (type = host)
TitleInfo
Title
Graduate School - New Brunswick Electronic Theses and Dissertations
Identifier (type = local)
rucore19991600001
Location
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NjNbRU
Identifier (type = doi)
doi:10.7282/T3BK19X8
Genre (authority = ExL-Esploro)
ETD doctoral
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Rights

RightsDeclaration (ID = rulibRdec0006)
The author owns the copyright to this work.
RightsHolder (type = personal)
Name
FamilyName
Wang
GivenName
Pin-wen
Role
Copyright Holder
RightsEvent
Type
Permission or license
DateTime (encoding = w3cdtf); (qualifier = exact); (point = start)
2013-03-28 16:00:52
AssociatedEntity
Name
Pin-wen Wang
Role
Copyright holder
Affiliation
Rutgers University. Graduate School - New Brunswick
AssociatedObject
Type
License
Name
Author Agreement License
Detail
I hereby grant to the Rutgers University Libraries and to my school the non-exclusive right to archive, reproduce and distribute my thesis or dissertation, in whole or in part, and/or my abstract, in whole or in part, in and from an electronic format, subject to the release date subsequently stipulated in this submittal form and approved by my school. I represent and stipulate that the thesis or dissertation and its abstract are my original work, that they do not infringe or violate any rights of others, and that I make these grants as the sole owner of the rights to my thesis or dissertation and its abstract. I represent that I have obtained written permissions, when necessary, from the owner(s) of each third party copyrighted matter to be included in my thesis or dissertation and will supply copies of such upon request by my school. I acknowledge that RU ETD and my school will not distribute my thesis or dissertation or its abstract if, in their reasonable judgment, they believe all such rights have not been secured. I acknowledge that I retain ownership rights to the copyright of my work. I also retain the right to use all or part of this thesis or dissertation in future works, such as articles or books.
RightsEvent
DateTime (encoding = w3cdtf); (qualifier = exact); (point = start)
2013-05-31
DateTime (encoding = w3cdtf); (qualifier = exact); (point = end)
2015-05-31
Type
Embargo
Detail
Access to this PDF has been restricted at the author's request. It will be publicly available after May 31st, 2015.
Copyright
Status
Copyright protected
Availability
Status
Open
Reason
Permission or license
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ETD
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windows xp
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