Clinical Trials
Автор: Steven Piantadosi
Год издания: 0000
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. 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.
Project Management in Clinical Trials
Автор: Alexey Levashov
Год издания:
The book is about both theoretical and practical aspects of Project Management in clinical trials. The audience may find explanation of different phenomena in modern clinical trials, for example, why some approaches in managing trials work and others – do not. In addition to this, the book should serve the purposes of business psychotherapy. The book is saturated with examples from real life and practical tips.
Staying the Course as a CIO. How to Overcome the Trials and Challenges of IT Leadership
Автор: Jonathan Mitchell
Год издания:
STAYING THE COURSE AS A CIO: HOW TO OVERCOME THE TRIALS AND CHALLENGES OF IT LEADERSHIP The shelf-life of a Chief Information Officer can be shockingly short. Few survive in post for more than a few years. More often each falls prey to insurmountable problems and their careers come to a sharp and ignominious end. In this book, a global CIO with over thirty years of experience in major corporations examines the main reasons why this happens. Readers will understand which types of issue can cause problems for an IT Leader and more importantly, they will learn strategies of how these problems can be minimized or even avoided. IT is often seen a technical backwater, but it is a discipline which has the capability to add massive value to an organisation whether it is in the private or the public sector – provided of course it has the right leadership doing the right things. Aspiring IT Leaders will need to deal with a common set of recurring trials and challenges. These include: · Overcoming the challenge of managing diverse and conflicting stakeholders · How to deal with large and complex projects · Making sense of software and how to handle the rapidly changing technology landscape · Knowing when to outsource and how to get the best out of an outsourcing partner · Harnessing the intellectual power of consultants to help you meet your goals · And last but not least, how to develop a set of strategies that are aligned with your corporate goals and then make sure your resources are properly targetted so that the IT function generates maximum positive impact for the enterprise. For IT professionals looking to fully integrate their function into the enterprise, 'Staying the Course as a CIO’ is a valuable source of practical advice, all based on real experience.