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A robust paradigm of finding the maximum tolerated dose in phase I cancer clinical trials with application to IL-21 denenicokin

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TitleInfo
Title
A robust paradigm of finding the maximum tolerated dose in phase I cancer clinical trials with application to IL-21 denenicokin
Name (type = personal)
NamePart (type = family)
Young
NamePart (type = given)
Tina Chang
NamePart (type = date)
1984-
DisplayForm
Tina Chang Young
Role
RoleTerm (authority = RULIB)
author
Name (type = personal)
NamePart (type = family)
Shih
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Weichung Joe
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Weichung Joe Shih
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Advisory Committee
Role
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chair
Name (type = personal)
NamePart (type = family)
LIN
NamePart (type = given)
YONG
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YONG LIN
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Advisory Committee
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internal member
Name (type = personal)
NamePart (type = family)
Moore
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Dirk F
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Dirk F Moore
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Advisory Committee
Role
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internal member
Name (type = personal)
NamePart (type = family)
Simonsen
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Katy L
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Katy L Simonsen
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Advisory Committee
Role
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outside member
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Rutgers University
Role
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degree grantor
Name (type = corporate)
NamePart
School of Public Health
Role
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school
TypeOfResource
Text
Genre (authority = marcgt)
theses
OriginInfo
DateCreated (qualifier = exact)
2017
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2017-05
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2017
Place
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xx
Language
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eng
Abstract (type = abstract)
In Phase I oncology trials, the main objective is typically to determine the maximum tolerated dose (MTD), the highest dose of a drug that does not cause unacceptable side effects. The MTD is determined by testing increasing doses on patient cohorts until the highest dose with acceptable side effects is found. To determine the MTD, many different dose escalation designs have been developed, such as the CRM, BLRM, mTPI-2, and BOIN, each of which has improved statistical properties over the traditional A+B class of designs. Yet most published Phase I trials still use a traditional 3+3 design. This dissertation proposes a robust paradigm of conducting Phase I cancer clinical trials that involves simultaneously running multiple designs to obtain a robust MTD. This paradigm will provide more confidence to clinicians and regulators in the selection of the dose for further drug development. The implementation of this paradigm with an application to the IL-21 denenicokin clinical development program is the focus of this dissertation.
Subject (authority = RUETD)
Topic
Public Health
Subject (authority = ETD-LCSH)
Topic
Clinical trials--Design
Subject (authority = ETD-LCSH)
Topic
Cancer--Treatment
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Rutgers University Electronic Theses and Dissertations
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ETD_7966
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electronic resource
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application/pdf
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Extent
1 online resource (xiv, 145 p. : ill.)
Note (type = degree)
Dr.P.H.
Note (type = bibliography)
Includes bibliographical references
Note (type = statement of responsibility)
by Tina Chang Young
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School of Public Health ETD Collection
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rucore10007500001
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Identifier (type = doi)
doi:10.7282/T3KW5JZD
Genre (authority = ExL-Esploro)
ETD doctoral
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Rights

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The author owns the copyright to this work.
RightsHolder (type = personal)
Name
FamilyName
Young
GivenName
Tina
MiddleName
Chang
Role
Copyright Holder
RightsEvent
Type
Permission or license
DateTime (encoding = w3cdtf); (qualifier = exact); (point = start)
2017-04-09 20:44:10
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Name
Tina Young
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Affiliation
Rutgers University. School of Public Health
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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)
2017-05-31
DateTime (encoding = w3cdtf); (qualifier = exact); (point = end)
2017-11-30
Type
Embargo
Detail
Access to this PDF has been restricted at the author's request. It will be publicly available after November 30th, 2017.
Copyright
Status
Copyright protected
Availability
Status
Open
Reason
Permission or license
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