In cancer research, a traditional phase II trial is designed as a single-arm trial that compares the experimental therapy to a historical control. This simple trial design has led to several adverse issues, including increased false positivity of phase II trial results and negative phase III trials. To rectify these problems, oncologists and biostatisticians have begun to use a randomized phase II trial that compares an experimental therapy with a prospective control therapy.
Randomized Phase II Cancer Clinical Trials explains how to properly select and accurately use diverse statistical methods for designing and analyzing phase II trials. The author first reviews the statistical methods for single-arm phase II trials since some methodologies for randomized phase II trials stem from single-arm phase II trials and many phase II cancer clinical trials still use single-arm designs. The book then presents methods for randomized phase II trials and describes statistical methods for both single-arm and randomized phase II trials. Although the text focuses on phase II cancer clinical trials, the statistical methods covered can also be used (with minor modifications) in phase II trials for other diseases and in phase III cancer clinical trials.
Suitable for cancer clinicians and biostatisticians, this book shows how randomized phase II trials with a prospective control resolve the shortcomings of traditional single-arm phase II trials. It provides readers with numerous statistical design and analysis methods for randomized phase II trials in oncology.
The Duke University Department of Biostatistics and Bioinformatics is proud to announce it is participating in the International Year of Statistics 2013, a worldwide celebration of the contributions of statistical science to the advancement of our global society.
More than 700 organizations - universities, research institutes, high schools, professional societies, government agencies and businesses - in nearly 100 countries are joining to celebrate and promote the importance of statistical science to the science community, businesses, governments, the news media, policymakers, employers, students and the public.
During this yearlong celebration, Duke B&B and the hundreds of other participating organizations around the world will be:
Be sure to visit the International Year of Statistics 2013 website in the months ahead to learn more about how Statistics helps shape your everyday life.
Thank you for visiting the Duke Department of Biostatistics and Bioinformatics website. This is an exciting time for biostatistics and bioinformatics and there is no better biomedical environment in which to work and/or study than a major medical center such as Duke. Our faculty members have the opportunity to collaborate with colleagues in all areas of clinical and translational research. The healthy collaborative environment here at Duke fosters long-lasting relationships and exposes us to the numerous methodological problems arising from the current explosion of medical data sources. We take pride in leading and participating in cutting edge research that has an impact on medicine around the world.
Elizabeth (Liz) DeLong
Professor and Chair
Department of Biostatistics and Bioinformatics
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