Clinical Trials - A Methodologic Perspective

Clinical Trials Comprehensive resource presenting methods essential in planning, designing, conducting, analyzing, and interpreting clinical trials The Fourth Edition of Clinical Trials builds on the text's reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for clinical trials, discussing principles of design for various types of clinical trials and elements of planning the experiment, assembling a study cohort, assessing data, and reporting results. Each chapter contains an introduction and summary to reinforce key points. Discussion questions stimulate critical thinking and help readers understand how they can apply their newfound knowledge. Written by a highly qualified author with significant experience in the field, the Fourth Edition of Clinical Trials approaches the topic with:

• Problems that may arise during a trial, and accompanying common sense solutions
• Design alternatives for addressing many questions in therapeutic development
• Statistical principles with new and provocative topics, such as generalizing results, operating characteristics, trial issues during the COVID-19 pandemic, and more
• Alternative medicine, ethics, middle development, comparative studies, adaptive designs, and clinical trials using point of care data
• Revamped exercise sets, updated and extensive references, new material on endpoints and the developmental pipeline, and revisions of numerous sections, tables, and figures

Standing out due to its accessible and broad coverage of statistical design methods which are the building blocks of clinical trials and medical research, Clinical Trials is an essential learning aid on the subject for undergraduate and graduate clinical trials courses.

Steven Piantadosi, MD, PhD, is Professor in Residence at Brigham and Women's Hospital and Harvard Medical School. He is one of the world's leading experts on the design and analysis of clinical trials. Dr. Piantadosi has been engaged with clinical trials for over 4 decades and taught the subject for more than 30 years. His research has focused on cancer but has involved many other therapeutic areas as well. He has published over 275 papers on research results, clinical applications, and trial methodology. Dr. Piantadosi has held leadership roles with national cooperative oncology groups, including the Alliance, a National Clinical Trials Network collaboration. He has also served as a member of numerous advisory and clinical trial monitoring committees.