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Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials - Handbooks of Modern Statistical Methods (Hardcover)
Loot Price: R5,398
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Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials - Handbooks of Modern Statistical Methods (Hardcover)
Series: Chapman & Hall/CRC Handbooks of Modern Statistical Methods
Expected to ship within 12 - 17 working days
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Handbook of Methods for Designing, Monitoring, and Analyzing
Dose-Finding Trials gives a thorough presentation of
state-of-the-art methods for early phase clinical trials. The
methodology of clinical trials has advanced greatly over the last
20 years and, arguably, nowhere greater than that of early phase
studies. The need to accelerate drug development in a rapidly
evolving context of targeted therapies, immunotherapy, combination
treatments and complex group structures has provided the stimulus
to these advances. Typically, we deal with very small samples,
sequential methods that need to be efficient, while, at the same
time adhering to ethical principles due to the involvement of human
subjects. Statistical inference is difficult since the standard
techniques of maximum likelihood do not usually apply as a result
of model misspecification and parameter estimates lying on the
boundary of the parameter space. Bayesian methods play an important
part in overcoming these difficulties, but nonetheless, require
special consideration in this particular context. The purpose of
this handbook is to provide an expanded summary of the field as it
stands and also, through discussion, provide insights into the
thinking of leaders in the field as to the potential developments
of the years ahead. With this goal in mind we present: An
introduction to the field for graduate students and novices A basis
for more established researchers from which to build A collection
of material for an advanced course in early phase clinical trials A
comprehensive guide to available methodology for practicing
statisticians on the design and analysis of dose-finding
experiments An extensive guide for the multiple comparison and
modeling (MCP-Mod) dose-finding approach, adaptive two-stage
designs for dose finding, as well as dose-time-response models and
multiple testing in the context of confirmatory dose-finding
studies. John O'Quigley is a professor of mathematics and research
director at the French National Institute for Health and Medical
Research based at the Faculty of Mathematics, University Pierre and
Marie Curie in Paris, France. He is author of Proportional Hazards
Regression and has published extensively in the field of dose
finding. Alexia Iasonos is an associate attending biostatistician
at the Memorial Sloan Kettering Cancer Center in New York. She has
over one hundred publications in the leading statistical and
clinical journals on the methodology and design of early phase
clinical trials. Dr. Iasonos has wide experience in the actual
implementation of model based early phase trials and has given
courses in scientific meetings internationally. Bjoern Bornkamp is
a statistical methodologist at Novartis in Basel, Switzerland,
researching and implementing dose-finding designs in Phase II
clinical trials. He is one of the co-developers of the MCP-Mod
methodology for dose finding and main author of the DoseFinding R
package. He has published numerous papers on dose finding,
nonlinear models and Bayesian statistics, and in 2013 won the Royal
Statistical Society award for statistical excellence in the
pharmaceutical industry.
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