This book presents the state of the art of biostatistical methods and their applications in
clinical oncology. Many methodologies established today in biostatistics have been brought
about through its applications to the design and analysis of oncology clinical studies. This
field of oncology now in the midst of evolution owing to rapid advances in biotechnologies and
cancer genomics is becoming one of the most promising disease fields in the shift toward
personalized medicine. Modern developments of diagnosis and therapeutics of cancer have also
been continuously fueled by recent progress in establishing the infrastructure for conducting
more complex large-scale clinical trials and observational studies. The field of cancer
clinical studies therefore will continue to provide many new statistical challenges that
warrant further progress in the methodology and practice of biostatistics. This book provides a
systematic coverage of various stages of cancer clinical studies. Topics from modern cancer
clinical trials include phase I clinical trials for combination therapies exploratory phase II
trials with multiple endpoints treatments and confirmative biomarker-based phase III trials
with interim monitoring and adaptation. It also covers important areas of cancer screening
prognostic analysis and the analysis of large-scale molecular data in the era of big data.
