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
RelatedItem (type = host)
TitleInfo
Title
Rutgers University Electronic Theses and Dissertations
Identifier (type = RULIB)
ETD
Identifier
ETD_7966
PhysicalDescription
Form (authority = gmd)
electronic resource
InternetMediaType
application/pdf
InternetMediaType
text/xml
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
RelatedItem (type = host)
TitleInfo
Title
School of Public Health ETD Collection
Identifier (type = local)
rucore10007500001
Location
PhysicalLocation (authority = marcorg); (displayLabel = Rutgers, The State University of New Jersey)
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