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A study of stagewise phase II and phase II/III designs for clinical trials

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TypeOfResource
Text
TitleInfo (ID = T-1)
Title
A study of stagewise phase II and phase II/III designs for clinical trials
Identifier
ETD_2883
Identifier (type = hdl)
http://hdl.rutgers.edu/1782.1/rucore10001600001.ETD.000056294
Language
LanguageTerm (authority = ISO639-2); (type = code)
eng
Genre (authority = marcgt)
theses
Subject (ID = SBJ-1); (authority = RUETD)
Topic
Public Health
Subject (ID = SBJ-2); (authority = ETD-LCSH)
Topic
Drugs--Testing
Subject (ID = SBJ-3); (authority = ETD-LCSH)
Topic
Drug development
Subject (ID = SBJ-4); (authority = ETD-LCSH)
Topic
Bayesian statistical decision theory
Subject (ID = SBJ-5); (authority = ETD-LCSH)
Topic
Decision making--Mathematical models
Abstract
Clinical trials play vital roles in drug development. Traditionally, phase II and phase III studies are conducted separately. However, in the pharmaceutical industry there is a recent trend toward combining phase II and phase III in a seamless fashion (a so-called phase II/III clinical trial). To first understand traditional phase II clinical trial designs, we develop two two-stage single-arm phase II clinical trial designs: a Bayesian-frequentist design and a Bayes factor-based design. Both designs control frequentist Type I and Type II error rates. Then we develop a varying-stage adaptive phase II/III clinical trial design. In this design, in addition to traditional initial learning stage (phase II) and final confirmatory stage (phase III), we also consider whether there is a need to have an intermediate stage to obtain more data, so that a more informative decision can be made to advance the trial to the final confirmatory stage. With respect to adaptations, we consider dropping dose arm(s), changing the primary study endpoint, determining sample size, and early stopping for futility. We use an adaptive combination test to perform final statistical analyses. Under conditional distribution of p-values or combined p-values, we derive Type I error rate and statistical power for each decision path. By applying closed testing procedure, we control family-wise Type I error rate at nominal level of α in the strong sense.
PhysicalDescription
Form (authority = gmd)
electronic resource
Extent
xvii, 169 p. : ill.
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application/pdf
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text/xml
Note (type = degree)
Ph.D.
Note (type = bibliography)
Includes bibliographical references
Note (type = vita)
Includes vita
Note (type = statement of responsibility)
by Gaohong Dong
Name (ID = NAME-1); (type = personal)
NamePart (type = family)
Dong
NamePart (type = given)
Gaohong
NamePart (type = date)
1971-
Role
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author
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Gaohong Dong
Name (ID = NAME-2); (type = personal)
NamePart (type = family)
Shih
NamePart (type = given)
Weichung Joe
Role
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chair
Affiliation
Advisory Committee
DisplayForm
Weichung Joe Shih
Name (ID = NAME-3); (type = personal)
NamePart (type = family)
Moore
NamePart (type = given)
Dirk
Role
RoleTerm (authority = RULIB)
internal member
Affiliation
Advisory Committee
DisplayForm
Dirk Moore
Name (ID = NAME-4); (type = personal)
NamePart (type = family)
Marcella
NamePart (type = given)
Stephen
Role
RoleTerm (authority = RULIB)
internal member
Affiliation
Advisory Committee
DisplayForm
Stephen Marcella
Name (ID = NAME-5); (type = personal)
NamePart (type = family)
Quan
NamePart (type = given)
Hui
Role
RoleTerm (authority = RULIB)
outside member
Affiliation
Advisory Committee
DisplayForm
Hui Quan
Name (ID = NAME-1); (type = corporate)
NamePart
Rutgers University
Role
RoleTerm (authority = RULIB)
degree grantor
Name (ID = NAME-2); (type = corporate)
NamePart
Graduate School - New Brunswick
Role
RoleTerm (authority = RULIB)
school
OriginInfo
DateCreated (qualifier = exact)
2010
DateOther (qualifier = exact); (type = degree)
2010
Place
PlaceTerm (type = code)
xx
RelatedItem (type = host)
TitleInfo
Title
Rutgers University Electronic Theses and Dissertations
Identifier (type = RULIB)
ETD
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/T34X57JM
Genre (authority = ExL-Esploro)
ETD doctoral
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Rights

RightsDeclaration (AUTHORITY = GS); (ID = rulibRdec0006)
The author owns the copyright to this work.
Copyright
Status
Copyright protected
Availability
Status
Open
Reason
Permission or license
RightsHolder (ID = PRH-1); (type = personal)
Name
FamilyName
Dong
GivenName
Gaohong
Role
Copyright Holder
RightsEvent (ID = RE-1); (AUTHORITY = rulib)
Type
Permission or license
DateTime
2010-09-20 12:52:56
AssociatedEntity (ID = AE-1); (AUTHORITY = rulib)
Role
Copyright holder
Name
Gaohong Dong
Affiliation
Rutgers University. Graduate School - New Brunswick
AssociatedObject (ID = AO-1); (AUTHORITY = rulib)
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.
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Technical

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ETD
MimeType (TYPE = file)
application/pdf
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application/x-tar
FileSize (UNIT = bytes)
1249280
Checksum (METHOD = SHA1)
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