Trial Techniques and Trials, Eleventh Edition

Power Analysis of Trials with Multilevel Data is a valuable reference for anyone who wants to perform power calculations on trials with hierarchical data. It provides a thorough overview of power analysis, familiarizing you with terminology and notation, outlining the key concepts of statistical power and power analysis, and covering all common hierarchical designs.

A revealing look at how the Orpheus myth helped Renaissance writers and thinkers understand the force of eloquence In ancient Greek mythology, the lyrical songs of Orpheus charmed the gods, and compelled animals, rocks, and trees to obey his commands. This mythic power inspired Renaissance philosophers and poets as they attempted to discover the hidden powers of verbal eloquence. They wanted to know: How do words produce action? In The Trials of Orpheus, Jenny Mann examines the key role the Orpheus story played in helping early modern writers and thinkers understand the mechanisms of rhetorical force. Mann demonstrates that the forms and figures of ancient poetry indelibly shaped the principles of sixteenth- and seventeenth-century scientific knowledge. Mann explores how Ovid's version of the Orpheus myth gave English poets and natural philosophers the lexicon with which to explain language's ability to move individuals without physical contact. These writers and thinkers came to see eloquence as an aesthetic force capable of binding, drawing, softening, and scattering audiences. Bringing together a range of examples from drama, poetry, and philosophy by Bacon, Lodge, Marlowe, Montaigne, Shakespeare, and others, Mann demonstrates that the fascination with Orpheus produced some of the most canonical literature of the age. Delving into the impact of ancient Greek thought and poetry in the early modern era, The Trials of Orpheus sheds light on how the powers of rhetoric became a focus of English thought and literature.

Statistical concepts provide scientific framework in experimental studies, including randomized controlled trials. In order to design, monitor, analyze and draw conclusions scientifically from such clinical trials, clinical investigators and statisticians should have a firm grasp of the requisite statistical concepts. The Handbook of Statistical Methods for Randomized Controlled Trials presents these statistical concepts in a logical sequence from beginning to end and can be used as a textbook in a course or as a reference on statistical methods for randomized controlled trials. Part I provides a brief historical background on modern randomized controlled trials and introduces statistical concepts central to planning, monitoring and analysis of randomized controlled trials. Part II describes statistical methods for analysis of different types of outcomes and the associated statistical distributions used in testing the statistical hypotheses regarding the clinical questions. Part III describes some of the most used experimental designs for randomized controlled trials including the sample size estimation necessary in planning. Part IV describe statistical methods used in interim analysis for monitoring of efficacy and safety data. Part V describe important issues in statistical analyses such as multiple testing, subgroup analysis, competing risks and joint models for longitudinal markers and clinical outcomes. Part VI addresses selected miscellaneous topics in design and analysis including multiple assignment randomization trials, analysis of safety outcomes, non-inferiority trials, incorporating historical data, and validation of surrogate outcomes.

I've been kidnapped by Zeus. Plucked from the streets of Manhattan and frightened half to death by a freaking Olympian god. And now I'm trapped in the Underworld, being forced to compete in a series of deadly trials for the position of Queen of the Underworld. Which would mean marrying Hades, the utterly terrifying Lord of the Dead. Who the hell wants a husband at all, let alone one made of smoke and riddled with death? I have to get back home, to New York and my brother. But I can't leave without completing the trials and they've been designed for a godly Queen, not Persephone - barista and botanical garden enthusiast. I'm surrounded by lethal, all-powerful maniacs. Sexy-as-hell maniacs, sure, but as dangerous as they come. And I'm going to have to prove to all of them that there's a goddess of hell inside me. It's the only way I'll survive the Hades Trials. But then what? And why, why, why am I so desperate to see under Hades smoky exterior and find out what he's hiding from me? If I win the trials, I have to marry the devil himself. But losing might mean losing my life. The Power of Hades is book 1 in the Hades Trials, which is intended for adults and is packed with magic, mythology and slow-burn soulmate romance! *Contains swearing and mature themes.*

Presents elements of clinical trial methods that are essential in planning, designing, conducting, analyzing, and interpreting clinical trials with the goal of improving the evidence derived from these important studies This Third Edition builds on the text’s reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for clinical trials. Readers will encounter the principles of design for various types of clinical trials, and are then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides common sense solutions. All stages of therapeutic development are discussed in detail, and the methods are not restricted to a single clinical application area. The authors bases current revisions and updates on his own experience, classroom instruction, and feedback from teachers and medical and statistical professionals involved in clinical trials. The Third Edition greatly expands its coverage, ranging from statistical principles to new and provocative topics, including alternative medicine and ethics, middle development, comparative studies, and adaptive designs. At the same time, it offers more pragmatic advice for issues such as selecting outcomes, sample size, analysis, reporting, and handling allegations of misconduct. Readers familiar with the First and Second Editions will discover revamped exercise sets; an updated and extensive reference section; new material on endpoints and the developmental pipeline, among others; and revisions of numerous sections. In addition, this book: • Features accessible and broad coverage of statistical design methods—the crucial building blocks of clinical trials and medical research -- now complete with new chapters on overall development, middle development, comparative studies, and adaptive designs • Teaches readers to design clinical trials that produce valid qualitative results backed by rigorous statistical methods • Contains an introduction and summary in each chapter to reinforce key points • Includes discussion questions to stimulate critical thinking and help readers understand how they can apply their newfound knowledge • Provides extensive references to direct readers to the most recent literature, and there are numerous new or revised exercises throughout the book Clinical Trials: A Methodologic Perspective, Third Edition is a textbook accessible to advanced undergraduate students in the quantitative sciences, graduate students in public health and the life sciences, physicians training in clinical research methods, and biostatisticians and epidemiologists. This book is accompanied by downloadable files available below under the DOWNLOADS tab. These files include: MATHEMATICA program – A set of downloadable files that tracks the chapters, containing code pertaining to each. SAS PROGRAMS and DATA FILES used in the book. The following software programs, included in the downloadables, were developed by the author, Steven Piantadosi, M.D., Ph.D: RANDOMIZATION – This program generates treatment assignments for a clinical trial using blocked stratified randomization. CRM – Implements the continual reassessment methods for dose finding clinical trials. OPTIMAL – Calculates two-stage optimal phase II designs using the Simon method. POWER – This is a power and sample size program for clinical trials. Executables for installing these programs can also be found at https://risccweb.csmc.edu/biostats/. Steven Piantadosi, MD, PhD, is the Phase One Foundation Distinguished Chair and Director of the Samuel Oschin Cancer Institute, and Professor of Medicine at Cedars-Sinai Medical Center in Los Angeles, California. Dr. Piantadosi is one of the world’s leading experts in the design and analysis of clinical trials for cancer research. He has taught clinical trials methods extensively in formal courses and short venues. He has advised numerous academic programs and collaborations nationally regarding clinical trial design and conduct, and has served on external advisory boards for the National Institutes of Health and other prominent cancer programs and centers. The author of more than 260 peer-reviewed scientific articles, Dr. Piantadosi has published extensively on research results, clinical applications, and trial methodology. While his papers have contributed to many areas of oncology, he has also collaborated on diverse studies outside oncology including lung disease and degenerative neurological disease.

This is a special edition of the complete Hades Trials series, in hardback. I've been kidnapped by Zeus. Plucked from the streets of Manhattan and frightened half to death by a freaking Olympian god. And now I'm trapped in the Underworld, being forced to compete in a series of deadly trials for the position of Queen of the Underworld. Which would mean marrying Hades, the utterly terrifying Lord of the Dead. Who the hell wants a husband at all, let alone one made of smoke and riddled with death? I have to get back home, to New York and my brother. But I can't leave without completing the trials and they've been designed for a godly Queen, not Persephone - barista and botanical garden enthusiast. I'm surrounded by lethal, all-powerful maniacs. Sexy-as-hell maniacs, sure, but as dangerous as they come. And I'm going to have to prove to all of them that there's a goddess of hell inside me. It's the only way I'll survive the Hades Trials. But then what? And why, why, why am I so desperate to see under Hades' smoky exterior and find out what he's hiding from me? If I win the trials, I have to marry the devil himself. But losing might mean losing my life.

This book explains statistics specifically for a medically literate audience. Readers gain not only an understanding of the basics of medical statistics, but also a critical insight into how to review and evaluate clinical trial evidence.

This extensively revised second edition is a unique and portable handbook focusing on clinical trials in surgery. It includes new educational materials addressing the rapid evolution of novel research methodologies in basic science, clinical and educational research. The underlying principles of clinical trials, trial design, the development of a study cohort, statistics, data safety, data monitoring, and trial publication for device and drug trials are also discussed. Clinical Trials provides a comprehensive resource on clinical trials in surgery and describes all the stages of a clinical trial from generating a hypothesis through to trial publication and is a valuable resource for all practicing and trainee academic surgeons.