This book gives the reader important accounts of basic statistical procedures used in clinical trials. It covers several areas of study, including biostatics, biomathematics, biometry and epidemiology. There is emphasis for trialists to learn good methodology while giving quality clinical treatment. Discusses and explores controversial issues such as ethics and offers pragmatic information regarding allegations of fraud or misconduct.
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STEVEN PIANTADOSI, MD, PhD, is Professor of Oncology and Director of Biostatistics at the Johns Hopkins Oncology Center. He also holds appointments in the Departments of Biostatistics and Epidemiology at the Johns Hopkins School of Hygiene and Public Health, and is the author of more than 100 articles on topics related to clinical trial methods and results.
A straightforward, authoritative review of basic statistical methods for clinical trials––an essential reference for physicians, biostatisticians, and students
Although there has been an explosion of literature on clinical trials in recent years, the demand for accessible coverage of statistical methods––the crucial building blocks of medical researchh––as remained unmet. As modern medicine advances toward defining a specialty in clinical research, Clinical Trials: A Methodologic Perspective responds to this pressing need. Steven Piantadosi′s hands–on approach, embracing a number of different trial designs and clinical fields, guides readers through the process of planning an experiment, putting together a study cohort, assessing data, and reporting results, and addresses the problems that are likely to confront any such study.
Supplemented with a data disk, dozens of illustrations, a comprehensive bibliography, reference listings, and a subject index, this invaluable volume:
∗ Covers such vital design considerations as controlling bias and random error, allocating treatments, and making decisions about terminating a study
∗ Emphasizes experimental designs to search for treatment advances of great clinical importance but modest size relative to the variability and bias which characterize studies of human disease
∗ Focuses on concepts that unify all types of clinical trials
∗ Explores areas of controversy such as ethics and offers pragmatic information regarding allegations of fraud or misconduct
∗ Includes summaries and discussion questions in each chapter
Striking a balance between qualitative clinical and rigorous statistical methods, this unique resource provides professionals, researchers, and students alike with the statistical tools they need to design and conduct their own trials.
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