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Author: Steven Piantadosi
Publisher: Springer Nature
ISBN: 3319526367
Category : Medical
Languages : en
Pages : 2573
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Book Description
This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.
Author: Chase Turner
Publisher:
ISBN: 9781734531909
Category :
Languages : en
Pages :
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Book Description
Can you imagine waking up tomorrow and having no anxiety at work, finances, marriage or health? Nearly every person deals with anxiety and everyone deals with stress. There are many reasons for this epidemic, but anxiety is a result of how we handle the stress that we and others place in our lives. One of the primary causes of stress is comparative living, which comes as a result of trying to be "normal". The T.R.I.A.L.S. method has been developed to help everyone in their daily routine and relationships so stress can be minimal, and anxiety can be avoided. This workbook is designed to help individuals in their daily walk to develop relationships in a way that will increase communication and decrease stress and anxiety. There is space for making goals and plans for carrying them out.
Author: Tom Brody
Publisher: Academic Press
ISBN: 0128042583
Category : Medical
Languages : en
Pages : 897
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Book Description
Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. - Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more - Extensively covers the "study schema" and related features of study design - Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials - Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers
Author: Alisha Rankin
Publisher: University of Chicago Press
ISBN: 9780226744858
Category : Science
Languages : en
Pages : 0
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Book Description
In 1524, Pope Clement VII gave two condemned criminals to his physician to test a promising new antidote. After each convict ate a marzipan cake poisoned with deadly aconite, one of them received the antidote, and lived—the other died in agony. In sixteenth-century Europe, this and more than a dozen other accounts of poison trials were committed to writing. Alisha Rankin tells their little-known story. At a time when poison was widely feared, the urgent need for effective cures provoked intense excitement about new drugs. As doctors created, performed, and evaluated poison trials, they devoted careful attention to method, wrote detailed experimental reports, and engaged with the problem of using human subjects for fatal tests. In reconstructing this history, Rankin reveals how the antidote trials generated extensive engagement with “experimental thinking” long before the great experimental boom of the seventeenth century and investigates how competition with lower-class healers spurred on this trend. The Poison Trials sheds welcome and timely light on the intertwined nature of medical innovations, professional rivalries, and political power.
Author: Emily L. Thuma
Publisher: Haymarket Books
ISBN:
Category : History
Languages : en
Pages : 281
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Book Description
A vital history of organizing within and beyond the walls of women’s prisons in the 1970s, illuminating a crucial chapter in today’s abolition feminist struggles. This new edition of an award-winning book features a foreword from acclaimed scholar-activist Sarah Haley and an afterword by Thuma. During the 1970s, grassroots activists within and beyond the walls of women’s prisons forged a radical politics against gender violence and incarceration. Scholar-activist Emily L. Thuma traces the making of this anticarceral feminism at the intersections of struggles for racial and economic justice, imprisoned and institutionalized people’s rights, and gender and sexual liberation. All Our Trials chronicles the organizing, ideas, and influence of those who placed criminalized and marginalized women at the heart of their antiviolence mobilizations. This activism confronted a "tough on crime" political agenda and clashed with the mainstream women’s movement’s strategy of resorting to the criminal legal system as a solution to sexual and domestic violence. Drawing on extensive research, Thuma weaves together the stories of mass defense campaigns, prisoner uprisings, coalition organizing, and activist publications that cut through prison walls. In the process, All Our Trials reveals a vibrant culture of opposition to interpersonal and state violence that both transforms our understanding of 1970s social movements and illuminates the history of present struggles for transformative justice. Winner of the 2020 Lambda Literary Award for LGBTQ Studies Shortlisted for the Organization of American Historians’ Nickliss Prize and the American Studies Association’s Romero Prize
Author: Marilynne K. Roach
Publisher: Taylor Trade Publications
ISBN: 9781589791329
Category : History
Languages : en
Pages : 760
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Book Description
The Salem Witch Trials is based on over twenty-five years of archival research--including the author's discovery of previously unknown documents--newly found cases and court records. From January 1692 to January 1697 this history unfolds a nearly day-by-day narrative of the crisis as the citizens of New England experienced it.
Author: Lawrence M. Friedman
Publisher: Springer Science & Business Media
ISBN: 9780387985862
Category : Medical
Languages : en
Pages : 384
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Book Description
This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.
Author: Susan Halabi, PhD
Publisher: Demos Medical Publishing
ISBN: 1935281763
Category : Medical
Languages : en
Pages : 396
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Book Description
Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout
Author: Freddie Stevenson
Publisher:
ISBN: 9780578915890
Category :
Languages : en
Pages :
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Book Description
Author: Steven Piantadosi
Publisher: Springer Nature
ISBN: 3319526367
Category : Medical
Languages : en
Pages : 2573
Get Book Here
Book Description
This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.
Author: Francis Hargrave
Publisher:
ISBN:
Category :
Languages : en
Pages : 1154
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Book Description
